201 Evidence Base (extract from the ‘Designed to Smile -­‐ How to Guide’) All components of D2S are informed by and underpinned with an evidence base. These have been researched by Cardiff University Dental Public Health Unit and are included in the Appendices. Appendix 1 – evidence base for tooth brushing Appendix 2 – evidence base for fluoride varnish Appendix 3 – evidence base for fissure sealant Appendix 4 – evidence base for behaviour change (oral health education) Appendix 5 – screen protocol 1
APPENDICES Appendix 1 Evidence -­‐ Based Advice on Tooth Brushing This document reviews the evidence for the use of a fluoride toothpaste/tooth brushing programme in nurseries and schools in Wales. The classification of the evidence and grades of recommendation assigned are based on those used by the journal for Evidence Based Dentistry (Appendix A). The evidence contained in this document while directed at supervised tooth brushing programmes in schools applies equally to children brushing their teeth at home and can be used by all members of the dental team in providing advice to parents and the carer of children on tooth brushing. Recommendations The results of these studies provide clear evidence in support of a supervised tooth brushing scheme for Wales. The recommendations based on the studies reviewed with the grade of evidence to support them are: Toothpaste containing 1350-­‐1500 ppm fluoride is used for all children aged 3 and over. For children aged 3-­‐6 years it is recommended Grade A that the amount of toothpaste dispensed be restricted to a pea-­‐size amount, For children aged less than 3 years, toothpaste containing no less than 1000 ppm fluoride should be used – the amount dispensed o the tooth brush being kept to a smear Children are given toothpaste and tooth brush for home use and advised to have their teeth brushed twice a day, preferable after breakfast and last thing at night Grade A Children are encouraged not to rinse their mouth after brushing. Grade A Until age 7, children should be supervised / helped when brushing their teeth. Children should not be allowed to lick or eat toothpaste from Grade C the tube. Like all medicines, toothpaste should be stored out of the reach of small children. The papers included in this review have been divided into four principle subject areas namely: use of fluoride toothpaste to prevent caries, the concentration of fluoride in toothpaste, the role of supervised brushing and the frequency of brushing and post-­‐brushing rinsing. For each subject area relevant papers have been identified and the results analysed. 2
Subject area Evidence Source In a systematic review of fluoride toothpaste, 70 studies contributed data for a meta-­‐analysis (involving 42,300 children). The results demonstrated that 24% of decay experience can be prevented by brushing with fluoride toothpaste. The effect of fluoride toothpaste increased with higher baseline levels of decay experience but was not influenced by exposure to water fluoridation. Marinho VCC, Higgins JPT, Logan S, Sheiham A. Fluoride toothpastes for preventing dental caries in children and adolescents. Cochrane Database of Systematic Reviews 2003, Issue 1. 54 studies contributed to a further systematic review of the caries preventive effect of fluoride toothpaste. The results revealed strong evidence for the effect of daily use of fluoride toothpaste in the young permanent dentition. The preventive fraction was 24.9%, with on average 0.58 fewer decayed, missing or filled tooth surfaces per year for children using fluoride toothpaste compared to placebo. Twetman S, Axelsson S, Dahlgren H, Holm A-­‐K, Källestål C, Lagerlöf F, Lingström P, Mejàre Supervised brushing A systematic review which included 12 studies demonstrated that children who participated in supervised tooth brushing programmes displayed a higher preventive fraction than those with unsupervised interventions both when compared to placebo (31.0% vs. 23.3%) and other fluoride containing controls (12.0% vs. 3.9%). There was strong evidence for the fact that supervised brushing with fluoride-­‐containing toothpaste had a superior caries preventive effect over non-­‐
supervised brushing. Twetman S, Axelsson S, Dahlgren H, Holm A-­‐K, Källestål C, Lagerlöf F, Lingström P, Mejàre I, Nordenram G, Norlund A, Petersson LG and Söder B (2003) Caries-­‐preventive effect of fluoride toothpaste: a systematic review, Acta Odontologica Scandinavica, 61:6, 347-­‐355. Ia Four years after the end of a 30 month randomised controlled trial of supervised tooth brushing with 1000ppm fluoride toothpaste at school, the intervention group still had significantly less caries than the non-­‐intervention group, demonstrating the prolonged benefit of the intervention. Pine CM, Curnow MM, Burnside G, Nicholson JA, Roberts AJ (2007) Caries prevalence four years after the end of a randomised controlled trial. Caries Res., 41(6):431 -­‐6. Ib Provision of fluoride toothpaste Level of evidence Ia Ia I, Nordenram G, Norlund A, Petersson LG and Söder B (2003) Caries-­‐preventive effect of fluoride toothpaste: a systematic review, Acta Odontologica Scandinavica, 61:6, 347-­‐355. 3
A randomised controlled trial of daily supervised tooth brushing in school with 1450ppm fluoride containing toothpaste demonstrated a reduction of 10.9% in caries for the intervention group compared to the control group Jackson RJ, Newman HN, Smart GJ, Stokes E, Hogan JI, Ib Brown C, Seres J. (2005) The effects of a supervised toothbrushing programme on the caries increment of primary school children, initially aged 5-­‐6 years. Caries Res.,39(2):108-­‐15. A two year clinical trial of an oral health programme involving health education and supervised daily tooth brushing with 1100ppm fluoride toothpaste for 3 year old children showed a reduction in caries increment of 30.6% for the children in the intervention group. Rong WS, Bian JY, Wang WJ, Wang JD. (2003) Effectiveness of an oral health education and caries prevention program in kindergartens in China. Community Dent Oral Epidemiol.,31(6):412-­‐6. Ib In a randomised controlled trial of daily supervised brushing in school for children aged 5 at the start of the study, the 2-­‐year caries increment on first permanent molars was 56% lower for caries into dentine for children in the intervention arm of the study than children in the control group. Curnow MM, Pine CM, Burnside G, Nicholson JA, Chesters RK, Huntington E. (2002) A randomised controlled trial of the efficacy of supervised toothbrushing in high-­‐caries-­‐risk children. Caries Res., 36(4): 294-­‐300. Ib Concentration of fluoride in toothpaste A study of supervised toothbrushing with 1200ppm fluoride toothpaste in nursery aged children demonstrated 10% fewer children with caries in the test group compared to a matched retrospective control group. Holtta P, Alaluusua S. (1992) Effect of supervised use of IIa a fluoride toothpaste on caries incidence in pre-­‐school children. Int. J. Paediatr. Dent., 2(3): 145-­‐9. A systematic review found a non-­‐significant difference (p=0.051) between caries levels and fluoride concentration in toothpaste, with an 8% increase in prevented fraction per 1000ppm fluoride. Marinho VCC, Higgins JPT, Logan S, Sheiham A. Fluoride toothpastes for preventing dental caries in children and adolescents. Cochrane Database of Systematic Reviews 2003, Issue 1. Ia 4
Four studies included in a review of low fluoride (<600ppm F) compared to standard fluoride toothpastes provided limited evidence for an anti-­‐caries difference between the fluoride concentrations. Twetman S, Axelsson S, Dahlgren H, Holm A-­‐K, Källestål Ia C, Lagerlöf F, Lingström P, Mejàre I, Nordenram G, Norlund A, Petersson LG and Söder B (2003) Caries-­‐preventive effect of fluoride toothpaste: a systematic review, Acta Odontologica Scandinavica, 61:6, 347-­‐355. Nine papers included in the evaluation of toothpastes with higher fluoride content found a significant higher caries reduction with a 1500ppm toothpaste compared to a standard formulation (1000ppm) with an average difference in prevented fraction of 9.7% (0-­‐22%). Six of the studies were high quality randomised controlled trials, which provided strong evidence that toothpastes containing 1500ppm had a superior preventive effect. Twetman S, Axelsson S, Dahlgren H, Holm A-­‐K, Källestål Ia C, Lagerlöf F, Lingström P, Mejàre I, Nordenram G, Norlund A, Petersson LG and Söder B (2003) Caries-­‐preventive effect of fluoride toothpaste: a systematic review, Acta Odontologica Scandinavica, 61:6, 347-­‐355. A systematic review included seven randomised controlled trials concluded that 250ppm fluoride toothpaste was not as effective in caries prevention in permanent teeth as those containing 1000ppm fluoride or more. Frequency of brushing and rinsing after brushing Ia Ammari AB, Bloch-­‐Zupan A, Ashley PF. (2003) Systematic review of studies comparing the anti-­‐caries efficacy of children’s toothpaste containing 600ppm of fluoride or less with high fluoride toothpastes of 1,000ppm or above. Caries Res., 37: 85-­‐92. In a systematic review of fluoride toothpaste the effect of fluoride toothpaste increased higher frequency of use such that there was a 14% increase in prevented fraction with twice daily brushing as opposed to once daily. Marinho VCC, Higgins JPT, Logan S, Sheiham A. Fluoride toothpastes for preventing dental caries in children and adolescents. Cochrane Database of Systematic Reviews 2003, Issue 1. Ia 5
Reported frequency of tooth brushing was strongly related to caries experience in a three year clinical trial of 12 year old children. Caries increment was 20% lower in participants who reported brushing more than once a day compared to those who reported brushing less than once per day. Overall frequency of brushing and rinsing method accounted for over 50% of the explained variance in caries increment. Chestnutt IG, Schafer F, Jacobsen APM, Stephen KW (1998) The influence of tooth brushing frequency and post-­‐brushing rinsing on caries experience in a caries clinical trial. Community Dent Oral Epidemiol, 26: 406-­‐
11. Ib A cross-­‐sectional study of 7 year old Flemish children found that children who brushed their teeth less than once a day were more likely to have decay than those who cleaned their teeth at least once a day (odds ratio 1.24, p=0.05). Vanobbergen J, Martens L, Lesaffre E, Bogaerts K, Declerck D. (2001) Assessing risk indicators for dental caries in the primary dentition. Community Dent Oral Epidemiol, 29: 424-­‐34. A cross-­‐sectional survey of pre-­‐school children in the UK found that in children from non-­‐manual backgrounds, 13% had decay if they brushed their teeth once a day or less compared to 8% of those who brushed more than once a day. For children from manual backgrounds the difference was not significant with 24% of children with decay for less frequent brushing and 21% for those who brushed twice daily. Gibson S, Williams S (1999) Dental caries in pre-­‐school children: associations with social class, tooth brushing habit and consumption of sugars and sugar-­‐containing foods. Caries Res, 33: 101-­‐13. III III 6
Results from the studies described provide clear evidence that: 1. 2. 3. 4. 5. Fluoride toothpaste reduces the incidence and severity of dental decay in children, The higher the concentration of fluoride in the toothpaste the greater its preventive effect, A supervised tooth brushing programme is more effective than an unsupervised programme, Twice daily use of a fluoride based toothpaste is more effective than less frequent use in reducing caries, Rinsing after tooth brushing reduces the effectiveness of the fluoride toothpaste. For young children the risk of dental fluorosis (a potentially unsightly discolouration of the teeth) from the ingestion of toothpaste has led to concerns about the concentration of fluoride in toothpaste. The critical period for the calcification of the upper incisors (front teeth) and therefore the risk of developing fluorosis is 22 -­‐25 months.1 Up to three years of age it is sensible to restrict the concentration of fluoride in toothpaste to 1000ppm and to use a smear on the brush to limit the risk of fluorosis to the upper front teeth whilst maximising the protective effect of fluoride. For children aged 3-­‐6 years, a pea-­‐sized amount of family fluoride toothpaste (1,350-­‐1,500 ppm fluoride) is indicated as the risk of fluorosis of cosmetic significance is small. 2 Commissioned by the Welsh Assembly Government and Produced by: Dental Public Health Unit Cardiff University Dental School June 2008 1 SIGN 83: Prevention and management of dental decay in the pre-­‐school child. November 2005 2 Delivering better oral health. An evidence based toolkit for prevention. Department of Health, England 2007 7
Classification of evidence levels and grades of recommendations Evidence Level Required Standard Ia Ib IIa Evidence obtained from meta-­‐analysis of RCT Evidence obtained from at least one RCT Evidence obtained from at least one well-­‐designed controlled study without randomisation IIb Evidence obtained from at least one other type of well-­‐designed quasi-­‐ experimental study* III Evidence obtained from well-­‐designed nonexperimental descriptive studies, e.g., comparative studies, correlation studies and case studies Evidence obtained from expert committee reports or opinions and/ or clinical experiences of respected authorities IV Grades of Recommendations A Requires at least one RCT as part of a body of literature of overall good quality and consistency addressing specific recommendation (evidence levels Ia, Ib) B Requires availability of well-­‐conducted clinical studies but no RCT on topic of recommendation (evidence levels IIa, IIb, III) C Requires evidence obtained from expert committee reports or opinions and/ or clinical experiences of respected authorities. Indicates an absence of directly applicable clinical studies of good quality (evidence level IV) *A situation in which implementation of an intervention is beyond the control of the investigators, but an opportunity exists to evaluate its effect. RCT, Randomised controlled trial. 8
Appendix 2 – Evidence for the effectiveness and use of fluoride varnish Evidence based technical document for fluoride varnish application
Designed to Smile, as announced by the Minister for Health and Social Services in April 2008, forms a key element of the oral health
improvement agenda in Wales.
The core programme comprises two parts, the supervised tooth brushing scheme for 3-5 year olds and a promotional programme for 6-11 year
olds. The core programme also includes the clinically appropriate use of other fluoride supplements.
This document reviews the evidence for the use of fluoride varnishes as a supplement to the toothpaste/tooth brushing programme in Wales.
The classification of evidence and grades of recommendation are based on those used by the journal for Evidence Based Dentistry (Appendix
A).
Recommendations
Children between the ages of 3 of 16 should be eligible for fluoride varnish
Grade A
Children from the ages of 6 months to 3 years who have a high risk of caries should be considered for fluoride varnish
applications
Grade A*
Children at high risk of dental caries or from high risk areas are advised to have topical fluoride varnish applications 2-4
times per year at regular intervals of 6 months or less
Grade A
Fluoride varnish needs to be delivered through a programme that encourages the participation of children from high
caries risk groups
Grade B
9
The papers have been divided into areas of; fluoride varnish, fluoride varnish as a supplement to fluoride toothpaste, the concentration and
dose of fluoride varnish preparations, frequency of application, fluoride varnish in high and low risk populations and programmes for the
delivery of fluoride varnishes.
Results from the studies reviewed provide evidence that: 1. Fluoride varnishes are effective in inhibiting caries.
2. Fluoride varnishes are effective in children from the ages of 3 to 16 years.
3. There is a small but inconclusive amount of evidence suggesting that children aged from 6 months in high risk groups would benefit
from fluoride varnish applications.
4. Fluoride varnish techniques are quick and acceptable to young patients.
5. Application of fluoride varnish for low risk populations at regular 6 monthly intervals would prevent caries in the population.
6. Application of fluoride varnishes for high risk populations at regular intervals of 4-6 months would prevent approximately 66-69% of
carious surfaces.
7. The most effective and tested concentration of fluoride varnish preparation is 22,600 ppm F-(2.2%F-).
For young children below the age of 3, there was only a small amount of evidence to support the use of fluoride varnishes.1 The lack of
evidence in this area does not demonstrate fluoride varnishes are not potentially appropriate or effective in the prevention of caries.
There are different definitions in studies for the risk of dental caries, with some studies using a child’s individual caries history as the indicator of
risk and other studies using area based measures, area DMFT and economic deprivation. Few studies compared the effects on fluoride
varnish on children with differing levels of risk. However there is a trend towards an increased preventative effect in high risk populations.
Studies have most frequently measured the mean number of carious surfaces in first permanent molar teeth. The overall effects of fluoride
varnish application on the other teeth in the dentition have been subject to less research.
10
There is limited evidence comparing community based programmes to deliver fluoride varnish. Non responses, lack of consent and drop out
rates have affected most studies of fluoride varnishes. Analysis of non-responders has shown that this population is the most likely to have
untreated dental caries2, therefore prevention programmes should aim to encourage participation from these groups.
Fluoride varnishes are not suitable for all children as they are contraindicated in children with ulcerative gingivitis and stomatitis.3 Children with
a history of hospital admissions for allergic episodes should not have varnish application as the preparation Duraphat contains colophony
(roisin), which can cause allergy in a small number of children.3
1
SIGN 83: Prevention and management of dental decay in the pre-school child. November 2005.
2
Splieth, C. H. et al. 2005. Responder and non-responder analysis for a caries prevention program. Caries Research 39(4), pp. 269-272.
3
Delivering better oral health. An evidence based toolkit for prevention. Department of Health, England 2007.
11
Subject area
Fluoride
varnish
Evidence
Source
In a systematic review of fluoride varnishes 9 studies were
included (involving 2709 children) of which 7 studies contributed
to a meta analysis. A mean of 33% fewer surfaces with caries in
the primary dentition and 46% fewer carious surfaces in the
adult dentition was seen in the population of children treated
with fluoride varnishes compared to those with no treatment.
Marinho VCC, Higgins JPT, Logan S, Sheiham
A. Fluoride varnishes for preventing dental
caries in children and adolescents. Cochrane
Database of Systematic Reviews 2002, Issue 1.
Art. No.: CD 002279. DOI:
10.1002/14651858.CD002279.
Twenty four trials including over 12,000 children were included
in a systematic review of the use of fluoride varnishes in
children. Children receiving fluoride varnish had a mean of 30%
fewer carious surfaces in permanent molars compared to a
placebo or no treatment. Children treated with fluoride varnish
had 17.8% fewer carious surfaces than active controls treated
with other fluoride treatments. In addition three trials compared
the effects of fluoride varnish on the deciduous dentition of
young children. One of the three studies found a mean of 44%
fewer surfaces with caries in the population treated with fluoride
varnish, while the other 2 studies did not have significant results.
Petersson LG, Twetman S, Dahlgren H, Norlund
A, Holm AK, Nordenram G, et al. Professional
fluoride varnish treatment for caries control: a
systematic review of clinical trials. Acta Odontol
Scand. 2004 Jun;62(3):170-6.
A systematic review of Duraphat fluoride varnish for the
prevention of caries included a meta analysis including 8 studies
involving 927 children. The population treated with fluoride
varnish had a mean of 38% fewer carious tooth surfaces than
untreated controls.
Helfenstein U, Steiner M.1994. Fluoride
varnishes (Duraphat): a meta-analysis.
Community Dentistry & Oral Epidemiology
22(1), pp. 1-5.
A systematic review of the literature identified 7 studies of
fluoride varnish use in the deciduous dentition, of which only two
were randomised controlled trials. The incidence of carious
surfaces was lower in population treated with fluoride varnish in
the studies, but the findings were statistically insignificant in 5 of
the 7 studies.
Rozier, R. G. and Rozier, R. G. 2001.
Effectiveness of methods used by dental
professionals for the primary prevention of
dental caries. Journal of Dental Education
65(10), pp. 1063-1072.
Level of
evidence
Ia
Ib
Ia
Ib
12
Fluoride varnish to
supplement fluoride
toothpaste
Concentration and
dose of fluoride
varnish
A randomised controlled single blind trial including 376 children
at enrolment tested the effect of applying fluoride varnish to
children who were between the ages of 6 and 44 months at the
start of the study. Despite errors in the allocation of fluoride
varnishes, children who did not have fluoride varnish treatment
had 50% more carious surfaces than the population treated with
fluoride varnishes. The children treated more frequently, with up
to 4 applications of with fluoride in a year had fewer new carious
lesions.
Weintraub, J. A. et al. 2006. Fluoride varnish
efficacy in preventing early childhood caries.
Journal of Dental Research 85(2), pp. 172-176.
One systematic review identified two studies comparing the
combination of fluoride varnish and fluoridated toothpaste with
toothpaste alone. One of the trials included compared the
effects of combined therapy (toothpaste and fluoride varnish) on
the percentage of new carious surfaces in permanent teeth, with
the population treated with varnish showing 48% fewer carious
surfaces. The second study showed that combined therapy
prevented 15% of carious surfaces in the deciduous dentition
compared to toothpaste alone.
Marinho VCC, Higgins JPT, Sheiham A, Logan
S. Combinations of topical fluoride (toothpastes,
mouthrinses, gels, varnishes) versus single
topical fluoride for preventing dental caries in
children and adolescents. Cochrane Database
of Systematic Reviews 2004, Issue 1. Art.
No.:CD002781. DOI: 10.1002/14651858.
CD002781.pub2.
A systematic review included a meta analysis of 4 studies
involving a total of 924 children; these studies compared fluoride
varnish and other fluoride delivery systems as controls. The
results indicated that fluoride varnish had a positive effect on
caries, with all but one of the studies demonstrating positive
findings but the study findings were not statistically significant.
Strohmenger L, Brambilla E. 2001. The use of
fluoride varnishes in the prevention of dental
caries: a short review.Oral Diseases. 7: 71–80.
There was no conclusive evidence identifying the most effective
concentration of fluoride varnish preparation. However one
systematic review noted that the most frequently used
concentration in studies used to demonstrate the effectiveness
of fluoride varnish was 22,600 (2.2%F ).
Azarpazhooh, A. Main, PA. 2008. Fluoride
varnish in the prevention of dental caries in
children and adolescents: a systematic
review.[reprint in Tex Dent J. 2008
Apr;125(4):318-37; PMID: 18491761]. Journal
(Canadian Dental Association) 74(1), pp. 73-79.
A systematic review of fluoride varnishes included 3 studies that
found single dose vials provided a more consistent dose of
fluoride than multidose vials, though no optimum dose was
specified.
Azarpazhooh, A. Main, PA. 2008. Fluoride
varnish in the prevention of dental caries in
children and adolescents: a systematic
review.[reprint in Tex Dent J. 2008
Apr;125(4):318-37; PMID: 18491761]. Journal
(Canadian Dental Association) 74(1), pp. 73-79
Ib
Ia
Ia
Ib
Ib
13
Frequency of
application
A systematic review of fluoride varnishes detailed the findings of
the 7 articles meeting the inclusion criteria. This concluded that
regular fluoride varnish application 2-4 times per year in the
deciduous and permanent dentition prevents caries in children.
Marinho VCC, Higgins JPT, Logan S, Sheiham
A. Fluoride varnishes for preventing dental
caries in children and adolescents. Cochrane
Database of Systematic Reviews 2002, Issue 1.
Art. No.: CD 002279. DOI:
10.1002/14651858.CD002279.
One randomised controlled trial compared different regimes for
the application for fluoride varnishes. Fluoride varnish applied
monthly prevented 76% of caries, whilst the 6 monthly
application of varnish prevented 57% of carious surfaces across
all of the populations.
Skold UM, Petersson LG, Lith A, Birkhead D.
2005. Effect of School-Based Fluoride Varnish
Programmes on Approximal Caries in
Adolescents from Different Caries Risk Areas.
Caries Research 39, pp. 273-279.
Fluoride varnish for
prevention in high and
low risk populations
In one randomised controlled trial, there was a greater
percentage of caries prevented in children living in areas with a
high risk of caries. Children from high risk areas treated with
fluoride varnish had 69% fewer carious surfaces, compared to
no varnish treatment, whereas there was a 20% reduction in the
caries in the population treated with fluoride varnish from a low
risk area.
Skold UM, Petersson LG, Lith A, Birkhead D.
Effect of School-Based Fluoride Varnish
Programmes on Approximal Caries in
Adolescents from Different Caries Risk Areas.
Caries Research 39, pp. 273-279.
Acceptability of
Fluoride varnish
A controlled trial compared the acceptability of professionally
applied fluoride delivery systems and concluded that fluoride
varnish was a faster procedure than other methods and patients
found this technique more acceptable.
Hawkins R, Noble J, Locker D, Weibe D, Murray
H, Weibe P, Frosina C, Clarke M. A comparison
of the costs and patient acceptability of
professionally applied topical fluoride foam and
varnish. Journal of Public Health Dentistry
64(2), pp. 106-110.
A randomised controlled trial applying fluoride varnish of very
young children’s teeth, Starting with children aged 6-44 months,
they reported little difficulty with co operation in this population.
Weintraub, J. A. et al. 2006. Fluoride varnish
efficacy in preventing early childhood caries.
Journal of Dental Research 85(2), pp. 172-176
Cluster Randomised controlled trial of a fluoride varnish
programme involved 334 children aged 6-7 in the test group and
330 in the control group in 32 schools. The study, which
involved the application in fluoride varnish to children in school
found significantly fewer enamel lesions in the treatment group
but did not find a significant reduction in caries in the children
receiving varnish. The lack of significance was attributed to the
population with the greatest likelihood of decay and subsequent
Hardman, MC. Davies, GM. Duxbury, JT
.Davies, RM. 2007. A cluster randomised
controlled trial to evaluate the effectiveness of
fluoride varnish as a public health measure to
reduce caries in children. Caries Research
41(5), pp. 371-376.
Fluoride varnish
programmes
Ib
Ia
Ib
IIa
Ib
Ib
14
potential for prevention not consenting to participate.
A cross sectional study was used to evaluate the effectiveness
of a caries prevention programme in Germany. Alongside tooth
brushing and oral health education this programme included
fluoride varnishes. Continual decreases in the population mean
DMFT for school children of all ages was observed year on year.
Dohnke-Hohrmann, S. Zimmer, S. et al. 2004.
Change in caries prevalence after
implementation of a fluoride varnish program.
Journal of Public Health Dentistry 64(2), pp. 96100.
III
15
Appendix A
Classification of evidence levels and grades of recommendations Evidence
level
Required standard
Ia
Evidence obtained from meta-analysis of RCT
Ib
Evidence obtained from at least one RCT
IIa
Evidence obtained from at least one well-designed controlled study without randomisation
IIb
Evidence obtained from at least one other type of well-designed quasi-experimental study
III
Evidence obtained from well-designed non experimental descriptive studies, eg, comparative studies, correlation studies and case studies
IV
Evidence obtained from expert committee reports or opinions and/ or clinical experiences of respected authorities
*
Grades of recommendations
A
Requires at least one RCT as part of a body of literature of overall good quality and consistency addressing specific recommendation
(evidence levels Ia, Ib)
B
Requires availability of well-conducted clinical studies but no RCT on topic of recommendation (evidence levels IIa, IIb, III)
C
Requires evidence obtained from expert committee reports or opinions and/ or clinical experiences of respected authorities. Indicates an
absence of directly applicable clinical studies of good quality (evidence level IV)
*
A situation in which implementation of an intervention is beyond the control of the investigators, but an opportunity exists to evaluate its effect.
RCT, Randomised controlled trial.
October 2008 Mrs I.G. Johnson, Professor I.G. Chestnutt, Dental Public Health Unit, Applied Clinical Research and Public Health, Cardiff University School of Dentistry. 16
Appendix 3 Evidence for the effectiveness of Fissure Sealants Fissure sealants are a preventive dental technology that are designed to specifically reduce the caries susceptibility of the occlusal (biting) surface of posterior teeth. In the context of the D2S programme this applies particularly to the first permanent molar teeth which erupt around age 6 years. In the period immediately following eruption, the occlusal surface of these teeth are particularly at risk. At age 15, 80% of the caries burden is to be found on this single tooth surface and so steps to protect it and reduce vulnerability in “high-­‐risk” 6-­‐7 year olds is important. The most commonly used type of fissure sealant is Bis-­‐GMA resin. This is a plastic material that is placed on the tooth surface and which forms a physical barrier between the tooth and the oral environment preventing the ingress of caries causing bacteria into the pit and fissures of the tooth surface. Recently published evidence suggests that an incipient carious lesions, confined to dental enamel do not progress when they are sealed and that cariogenic bacteria do not survive under sealants. For this reason, unless there is suspicion that dental caries has progressed into dentine (when operative intervention is then required), all first permanent molars should be sealed in children deemed at higher risk. This means it is appropriate to seal “stained fissures”. From the perspective of D2S, higher risk is on the basis of residence in an area of high caries prevalence. 17
Subject Area Evidence of caries prevention Evidence A 2013 Cochrane review examined the evidence for the caries preventive effect of fissure sealants. Thirty-­‐four trials are included in the review. Twelve trials evaluated the effects of sealant compared with no sealant (2575 participants); 21 trials evaluated one type of sealant compared with another (3202 participants); and one trial evaluated two different types of sealant and no sealant (752 participants). Children were aged from 5 to 16 years. Trials rarely reported the background exposure to fluoride of the trial participants or the baseline caries prevalence. Source Level of Evidence Ahovuo-­‐Saloranta A, Forss H, Walsh T, Hiiri A, Nordblad A, Mäkelä M, Worthington HV. Sealants for preventing dental decay in the permanent teeth. Cochrane Database of Systematic Reviews 2013, Issue 3. Art. No.: CD001830. DOI: 10.1002/14651858.CD001830.pub4. http://onlinelibrary.wiley.com/doi/10.1002/146
51858.CD001830.pub4/pdf Resin-­‐based sealant compared with no sealant: Compared to control without sealant, second or third or fourth generation resin based sealants prevented caries in first permanent molars in children aged 5 to 10 years (at 2 years of follow-­‐up odds ratio (OR) 0.12, 95% confidence interval (CI) 0.07 to 0.19, six trials (five published in the 1970s and one in 2012), at low risk of bias, 1259 children randomised, 1066 children evaluated, moderate quality evidence). If we were to assume that 40% of the control tooth surfaces were decayed during 2 years of follow-­‐up (400 carious teeth per 1000), then applying a resin-­‐based sealant will reduce the proportion of the carious surfaces to 6.25% (95% CI 3.84% to 9.63%); similarly if we were to assume that 70% of the control tooth surfaces were decayed (700 carious teeth per 1000), then applying a resin-­‐based sealant will reduce the proportion of the carious surfaces to 18.92% (95% CI 12.28% to 27.18%). This caries preventive effect was maintained at longer follow-­‐up but both the quality and quantity of the evidence was reduced (e.g. at 48 to 54 months of follow-­‐up OR 0.21, 95% CI 0.16 to 0.28, four trials (two studies at low risk of bias and two studies at high risk of bias), 18
482 children evaluated; risk ratio (RR) 0.24, 95% CI 0.12 to 0.45, one study at unclear risk of bias, 203 children evaluated). The application of sealants is a recommended procedure to prevent or control caries. Sealing the occlusal surfaces of permanent molars in children and adolescents reduces caries up to 48 months when compared to no sealant, after longer follow-­‐up the quantity and quality of the evidence is reduced. The review revealed that sealants are effective in high risk children but information on the magnitude of the benefit of sealing in other conditions is scarce. The relative effectiveness of different types of sealants has yet to be established. Evidence of relevance to the placement of fissure sealants in a school based programme In relation to each of the aims, the review came to the following Gooch BF, Griffin SO, Gray SK et al. Preventing conclusions: dental caries through school based sealant programs: updated recommendations and 1 Sound pit and fissure surfaces. What is the effectiveness reviews of evidence. Journal of the American of sealants in preventing the development of caries on sound Dental Association. 2009;140(11):1356-­‐65. pit and fissure surfaces? Summary of evidence. Systematic http://www.ncbi.nlm.nih.gov/pubmed/?term=
reviews have found that sealants are effective in preventing the Gooch+BF%2C+Griffin+SO%2C+Gray+SK+et+al.+
development of caries on sound pit and fissure surfaces in Preventing+dental+caries+through+school+base
children and adolescents. d+sealant+programs%3A+Journal+of+the+Amer
2 Noncavitated or incipient lesions. What is the ican+Dental+Association.+2009%3B140(11)%3A
effectiveness of sealants in preventing the progression of 1356-­‐65. noncavitated or incipient carious lesions to cavitation? Summary of evidence. A systematic review found that pit-­‐and-­‐
fissure sealants are effective in reducing the percentage of noncavitated carious lesions that progressed to cavitation in children, adolescents and young adults. 3 Bacteria levels. What is the effectiveness of sealants in reducing bacteria levels in cavitated carious lesions? Summary of evidence. A systematic review found that pit-­‐and-­‐fissure sealants are effective in reducing bacteria levels in cavitated 19
carious lesions in children, adolescents and young adults. 4 Assessment of caries on surfaces to be sealed. Which caries assessment methods should be used in SBSPs to differentiate pit and fissure surfaces that are sound or noncavitated from those that are cavitated or have signs of dentinal caries? Summary of evidence. A systematic review found that visual assessment alone is sufficient to detect the presence of surface cavitation and/or signs of dentinal caries. 5 Surface preparation. What surface cleaning methods or techniques are recommended by manufacturers for unfilled resin-­‐based sealants (self-­‐curing and light-­‐cured) commonly used in SBSPs? Summary of evidence. A review of manufacturers’ instructions for use for unfilled resin-­‐based sealants found that they do not specify a particular method of cleaning the tooth surface. 6 Effect of clinical procedures. What is the effect of clinical procedures—specifically, surface cleaning or mechanical preparation methods with use of a bur before acid etching—on sealant retention? Summary of evidence. The effect of specific surface cleaning or enamel preparation techniques on sealant retention cannot be determined because of the small number of clinical studies comparing specific techniques and, for mechanical preparation with a bur, inconsistent findings. Bivariate and multivariate analyses of retention data across existing studies suggest that supervised tooth brushing or use of a hand piece prophylaxis may result in similar sealant retention rates over time. 7 Four-­‐handed technique for applying dental sealant. Does use of a four-­‐handed technique in comparison with a two-­‐handed technique improve sealant retention? Summary of evidence. In the absence of direct comparative studies, the results of a 20
multivariate study of available data19 suggest that use of the four-­‐handed placement technique is associated with a 9 percentage point increase in sealant retention. 8 Caries risk associated with lost sealants. Are teeth in which sealants are lost at a higher risk of developing caries than are teeth that were never sealed? Summary of evidence. Findings from a meta-­‐analysis indicate that the caries risk for sealed teeth that have lost some or all sealant does not exceed the caries risk for never-­‐sealed teeth. Thus, the potential risk associated with loss to follow-­‐up for children in school-­‐based programs does not outweigh the potential benefit of dental sealants. Evidence of relevance to the placement of fissure sealants in a school based programme In relation to each of the aims, the review came to the following Gooch BF, Griffin SO, Gray SK et al. Preventing conclusions: dental caries through school based sealant programs: updated recommendations and 1 Sound pit and fissure surfaces. What is the effectiveness reviews of evidence. Journal of the American of sealants in preventing the development of caries on sound Dental Association. 2009;140(11):1356-­‐65. pit and fissure surfaces? Summary of evidence. Systematic http://www.ncbi.nlm.nih.gov/pubmed/?term=
reviews have found that sealants are effective in preventing the Gooch+BF%2C+Griffin+SO%2C+Gray+SK+et+al.+
development of caries on sound pit and fissure surfaces in Preventing+dental+caries+through+school+base
children and adolescents. d+sealant+programs%3A+Journal+of+the+Amer
2 Noncavitated or incipient lesions. What is the ican+Dental+Association.+2009%3B140(11)%3A
effectiveness of sealants in preventing the progression of 1356-­‐65. noncavitated or incipient carious lesions to cavitation? Summary of evidence. A systematic review found that pit-­‐and-­‐
fissure sealants are effective in reducing the percentage of noncavitated carious lesions that progressed to cavitation in children, adolescents and young adults. 3 Bacteria levels. What is the effectiveness of sealants in reducing bacteria levels in cavitated carious lesions? Summary of evidence. A systematic review found that pit-­‐and-­‐fissure 21
sealants are effective in reducing bacteria levels in cavitated carious lesions in children, adolescents and young adults. 4 Assessment of caries on surfaces to be sealed. Which caries assessment methods should be used in SBSPs to differentiate pit and fissure surfaces that are sound or noncavitated from those that are cavitated or have signs of dentinal caries? Summary of evidence. A systematic review found that visual assessment alone is sufficient to detect the presence of surface cavitation and/or signs of dentinal caries. 5 Surface preparation. What surface cleaning methods or techniques are recommended by manufacturers for unfilled resin-­‐based sealants (self-­‐curing and light-­‐cured) commonly used in SBSPs? Summary of evidence. A review of manufacturers’ instructions for use for unfilled resin-­‐based sealants found that they do not specify a particular method of cleaning the tooth surface. 6 Effect of clinical procedures. What is the effect of clinical procedures—specifically, surface cleaning or mechanical preparation methods with use of a bur before acid etching—on sealant retention? Summary of evidence. The effect of specific surface cleaning or enamel preparation techniques on sealant retention cannot be determined because of the small number of clinical studies comparing specific techniques and, for mechanical preparation with a bur, inconsistent findings. Bivariate and multivariate analyses of retention data across existing studies suggest that supervised tooth brushing or use of a hand piece prophylaxis may result in similar sealant retention rates over time. 7 Four-­‐handed technique for applying dental sealant. Does use of a four-­‐handed technique in comparison with a two-­‐handed technique improve sealant retention? Summary of evidence. In 22
the absence of direct comparative studies, the results of a multivariate study of available data19 suggest that use of the four-­‐handed placement technique is associated with a 9 percentage point increase in sealant retention. 8 Caries risk associated with lost sealants. Are teeth in which sealants are lost at a higher risk of developing caries than are teeth that were never sealed? Summary of evidence. Findings from a meta-­‐analysis indicate that the caries risk for sealed teeth that have lost some or all sealant does not exceed the caries risk for never-­‐sealed teeth. Thus, the potential risk associated with loss to follow-­‐up for children in school-­‐based programs does not outweigh the potential benefit of dental sealants. 23
Appendix 4 Evidence of relevance to Behaviour Change (oral health education) The role of traditional classroom based oral health education. Systematic reviews of the research evidence show that traditional classroom based oral health education is ineffective in improving oral health (Sprod et al. 1996; Kay and Locker, 1998). These reviews concluded that interventions which do not include the provision of fluoride do nothing to prevent dental caries and in fact have the potential to widen oral health inequalities. One to one health education in a clinical context, at the chair-­‐side with parent and child is useful as tailored one-­‐to one advice on diet and fluoride use can be provided. However, the current evidence shows that there is no place for traditional class-­‐room teaching in groups, and especially not with young children. While this may play some part in providing knowledge, it does nothing to change behaviour, particularly in those children at greatest risk (Davies and Bridgeman, 2011). It is for these reasons that the Designed to Smile programme does not provide traditional stand-­‐alone class teaching by oral health education teams – it is not an effective use of resources. The provision of oral health education is to support and enhance the implementation of daily brushing and fluoride varnish programmes which are more likely to bring about clinical change and address oral health inequalities (Shaw et al. 2009; Macpherson et al. 2013). References Davies, G. and C. Bridgman (2011). "Improving oral health among schoolchildren -­‐ which approach is best?" British Dental Journal 210(2): 59-­‐61. Kay, E. and D. Locker (1998). "A systematic review of the effectiveness of health promotion aimed at improving oral health." Community Dental Health 15(3): 132-­‐144. Macpherson, L. M., Y. Anopa, D. I. Conway and A. D. McMahon (2013). "National supervised tooth brushing program and dental decay in Scotland." Journal of Dental Research 92(2): 109-­‐113. 24
Shaw, D., L. Macpherson and D. Conway (2009). "Tackling socially determined dental inequalities: ethical aspects of Childsmile, the national child oral health demonstration programme in Scotland." Bioethics 23(2): 131-­‐139. Sprod A.J., Anderson, R. and Treasure, E,T. (1996) Effective oral health promotion : literature reviewUniversity of Wales. College of Medicine. Dental Public Health Unit.; Health Promotion Wales.Cardiff : Dental Public Health Unit, UWCM : Health Promotion Wales. 25
Appendix 5 Screening Protocol All Wales CDS school dental screening / inspection protocol
This protocol has been developed as part of the Welsh Government’s National Oral Health Plan commitment to work with PHW to
consider evidence regarding dental screening, review the current school screening programme in Wales, and update advice to CDS.
It is informed by Public Health Wales review of school screening (Hyperlink Screening Protocol literature overview). It is to be used
by all CDS in Wales.
This document and the Ministerial Letter on the Role of the CDS (EH/ML/014/08) refer to school dental screening, but it is important
to note the legal framework refers to “inspection”. See Appendix 2
Published January 2014
To be reviewed January 2017
The purpose of screening
There is no evidence to show that traditional school screening per se encouraged children with dental need to attend a dentist. This
all Wales protocol focuses on links with Designed to Smile which has the potential to offer appropriate follow up in defined
circumstances. Thus The primary purpose of screening is to
• identify children with erupted first permanent molars (FPMs) which can be fissure sealed or have fluoride varnish
applied, and
• identify children who may benefit from fluoride varnish application where local policy includes screening for this.
26
Screening may also 1. Identify children with dental and oral disease / conditions requiring active treatment and inform their parents / people with
parental responsibility (e.g where there is acute or spreading dental infection)
2. Facilitate those children to obtain appropriate treatment
3. Foster effective working relationships with schools and nurseries
Children to be screened
No children in secondary schools will be screened – unless identified as school for children with special needs
In Wales the only children who will be screened are those in relevant year-groups in schools participating in D2S
programme. That is primary school years 2 and 3 and 4
CDS may offer screening to the following groups as capacity and resources allow
•
•
•
Special schools/units
Children in D2S eligible schools who have refused to participate in D2S, or who have withdrawn from the programme (in part
or wholly). These children attend schools in areas of multiple deprivation and should be offered screening
Other children in D2S participant schools, particularly where local decision is to pre-screen before applying fluoride varnish
to teeth other than FPMs
•
School where Mobile Dental unit visits to provide treatment
•
Primary Schools in area with high Welsh Index Multiple Deprivation (WIMD) super output area, but not already in D2S or
eligible for D2S. That is schools where recent epidemiological data shows significantly higher rates of caries as identified by
Welsh Oral Health Information Unit (If requested, WOHIU will help CDS to identify these schools)
27
Welsh Government expect that children in year groups 2, 3 and 4 of D2S eligible schools will be offered screening in at least one of
these year groups
Schools in areas of low need
These schools (as defined by WIMD) will not be offered screening, but CDS may offer to provide parents with written reminders of
the importance of dental attendance.
Consent to screening
•
•
•
•
Consistent with D2S, and including medical history as appropriate
In D2S year groups everyone is eligible for tooth brushing whether or not they consent to screening
Children can only be offered Fissure Sealants if they have been screened
Screening of children for fluoride varnish is for Local Health Board and CDS decision. Where screening is not undertaken
there will be clear written processes on identifying and providing fluoride varnish for these children.
Clinical criteria for school screening
The main criteria relate to Designed to Smile
•
child for fissure sealant under D2S (as per local D2S provision) where first permanent molars are sufficiently erupted
and good moisture control possible
•
child for fluoride varnish under D2S (as per local D2S provision) where first permanent molars are sufficiently erupted
•
caries in primary dentition (primarily as a marker for risk of caries in the permanent dentition)
Screening may also identify children who could benefit from fluoride varnish on teeth other than first permanent molars. Screening
of children for fluoride varnish alone is for Health Board and CDS decision
Additional criteria which require standard letter to parent / person with parental responsibility are -
•
evidence of pathology including localised sepsis, generalised oral infection, mucosal lesion(s)
•
permanent incisors darkened / discoloured / fractured into dentine
•
caries in permanent dentition
•
child with either gross plaque, calculus or swollen gums
28
•
dental developmental anomalies, E.g. Supernumary tooth, potential malocclusion
Dental professionals will use their clinical judgement to note any other oral health issues or concerns about the child’s health and
well-being
(Adapted from Kearney-Mitchell et al, 2006 as noted in PHW review)
Data collection
Data will be collected in a standardised format which includes:
General
• Date of screening,
• Name/ GDC number of dental professional
• School name,
Child specific
• Child name and D.O.B,
• Confirmation of positive consent
• Year group and class.
• Child absent for screening
• Child refused screening
• Child scores positive to any of the criteria -record the criteria and relevant clinical data.
• Other Observations/comments e.g. safeguarding concern
Screening Process and Documentation required
The operational process for screening is described by the Community Dental Service Clinical Directors and standard
documentation is included as part of the process.
Every child will receive a feedback letter whether or not they require follow up as part of D2S programme or for other clinical
reason.
If requested the CDS must respond appropriately and promptly to facilitate access to dental care.
29
Consider providing a report letter to Head teacher giving information on number screened, number who require treatment, number
who don’t require treatment etc. This information can be useful basis for discussion on Design to Smile where a school may be
considering withdrawing from the programme.
This protocol was developed with the support and expertise of Public Health Wales dental governance team and the CDS in Wales.
30