Journal of Medicine and Medical Science Vol. 2(4) pp.794-804, April 2011 Available online @http://www.interesjournals.org/JMMS Copyright © 2011 International Research Journals Full Length Research Paper Model development of mandibular two-implant retained overdentures plus nutritional empowerment in elderly with dentures (need) (Intermediate outcome) Nawakamon Suriyan1* DDS, PGDip OMFS, FICOI, Ph.D PH (candidate), Sathirakorn Pongpanich2 BEcon, MA, Ph.D, Surasak Taneepanichskul3 MD., MSc, FRCOGT , Settakorn Pongpanich4, MD, DDS, FDSRCS (Edin). 1 Dental Implantologist, Prachatipat Hospital, Pathumthani, Thailand Associate Dean and Director of Ph.D Study, College of Public Health Sciences, Chulalongkorn University, Bangkok, Thailand 3 Dean, College of Public Health Sciences, Chulalongkorn University, Bangkok, Thailand 4 Assistance Professor, Prince of Songkhanakarin University, Thailand 2 Accepted 28 April, 2011 It is unclear whether the replacement of conventional dentures with mandibular two implant-retained overdentures alters the diet selection and thus improves nutritional status and quality of life of elderly edentulous persons. In this randomized clinical trial, the objective was to explore the effectiveness of IODNEED programme. Population was Thai male and female, aged over 65years and edentulous for at least 1 year, n=33 in each group, living in Pathumthani Province, Thailand. Intervention was Mandibular two implant-retained Overdentures (IOD) plus NEED (Nutritional Empowerment in Edentulous people with Dentures). Comparison was among IODNEED, IOD only; Conventional dentures (CD) plus NEED and CD only. Outcome was post-treatment differences in satisfaction, oral heath related quality of life and nutritional status and anthropometric and blood parameters among the groups and measured pretest, post 1 month, post 3 months and post 6 months. The research results found that all general characteristics and pretest mean scores of most of the measured variables were not statistically significant difference among the four groups (p-value >.05). Pretest mean scores of nearly all of variables measured among the four groups were not significant different (p-value >.05). At post 6 months assessment, in IODNEED group, the best improvement was seen in most of the variables than other three groups such as oral health related quality of life, masticatory function, satisfaction, nutritional status, body mass index, daily diet intake, and 6 out of 7 items of blood nutrient parameters were significantly higher than pretest (p-value <.001). Comparison between IODNEED and IOD, mean scores of serum albumin, serum Iron, and red blood cells were significantly increased ((p-value <.001) in IODNEED. Between IODNEED and CDNEED, nearly all of the variables such as oral heath related quality of life; mastication function, nutritional status, and 4 out of 7 blood parameters were significantly increased in IODNEED (p-value < .02). From the results of correlation and regression analysis of cost-effectiveness, IODNEED was better than IOD and CDNEED was better than CD in term of oral health related quality of life and satisfaction (p-value < .001). Regarding masticatory function, IOD was 6 times more effective than CD, in our studied population (p-value < .001). we can concluded that “IODNEED” program had more effective in improvement of oral health related quality of life, mastication function, satisfaction for mandibular, nutritional status, BMI, body fat percentage (skin fold thickness), and blood parameters. Moreover, it can also be concluded that “NEED” had not only improvement in mean scores of studied parameters but also effective by cost. Regular participatory nutritional empowerment and isometric exercise should be provided in conjunction with mandibular two implant-retained overdentures in elderly edentulous Thai citizens. Key words: mandibular two implant-retained overdentures, dental implants, edentulous, elderly, nutrition, dental prosthesis, cost-effectiveness, Funyim INTRODUCTION Oral health is a standard of the oral and related tissues which enables an individual to eat, speak and socialize *Corresponding author: nawakamons@hotmail.com without active disease, discomfort or embarrassment and which contributes to general well-being (WHO, 1983). In Thailand, the senior edentulous citizens waiting for dental implants are 107, 366 persons, whereas, 2155 are residing in Bangkok and 1038 in Pathumthani province. Suriyan et al. 795 (King project MOPH Thailand, 2008). Conventional dentures “CD” could not chew many types of foods, particularly raw vegetables and other hard and tough foods (Hartsook, 1974; Wayler and Chauncey, 1983; Chauncey et al., 1984). On the other hand, mandibular two implant-retained overdentures “IOD” not only can chew most of the foods (Feine et al., 1994; Geertman et al., 1999) but also provides significantly greater satisfaction, masticatory function, and oral healthrelated quality of life (OHRQoL) than CD (Awad et al., 2000). A few studies had reported deficiencies of isolated nutrients in denture wearers, but there was no consistent pattern. (Papas et al., 1998; Joshipura et al., 1996; Greksa et al., 1995) Moreover, some studies generally had shown that prosthetic rehabilitation in the absence of dietary counseling does not lead to dietary improvement (Moynihan and Bradbury , 2001; Moynihan et al., 2006; Hildebrandt et al., 1997; Sahyoun et al., 2003; Sheiham et al., 2001). In this study, we explored the effectiveness of IOD plus NEED programme by making comprehensive comparison of the efficacies among three intervention groups and control group in Thai elderly edentulous people in Prachatipat hospital, Pathumthani province, in the aspect of satistisfaction, OHRQoL, nutritional improvement and cost-effectiveness. Thus we empowered one of the factor related to food choice i.e knowledge, attitude and practice concerning about healthy diet by NEED (Nutritional Empowerment in Edentulous people with Dentures) programme using participatory learning approach. Our research question was “Can the combine effect of two interventions (IODNEED) have better improvement in patient satisfaction and nutritional status than the other compared groups; IOD only, CDNEED, and CD only”. We tested the null-hypothesis that there are no difference in satisfaction, oral heath related quality of life and nutritional status and anthropometric and blood parameters among the groups and measured at pretest, post 1 month, post 3 months and post 6 months. MATERIAL AND METHODS This study was a Randomized clinical trial. This study was conducted in Prachatipat hospital, Pathumthani province, Thailand. The study population for this study were Thai edentulous people over 65 –year old age attending (King project) “Project Dental Implant Honor” during the study period from September 2010 to March 2011. The subjects were recruited from the waiting list of elderly edentulous persons residing in Pathumthani Province. The subjects were invited to participate in this study by telephone conversation. All the patients who agreed the study protocol were screened according to inclusion criteria and exclusion criteria. Informed written consent was obtained from all participants. The estimated sample size was calculated by comparisons of two means formula, according to standard statistical criteria (α =0.05, power of the test = 90%). Difference between means and standard deviation of two groups was used from previous study in 2003, primary outcome patients’ satisfaction VAS, visual analogue scale (Morais J.A et al., 2003). The sample size calculated was 27 per each group and we added another 20 percent for estimated attrition. Participants were randomly allocated to each of the four studied groups. Subjects received either mandibular two implant-retained overdentures (n=66) by “Funyim” Titanium grade IV, ISO 13485, provided from King, manufactured in ADTEC (Advanced Dental Technology Center), Thailand or conventional completes dentures (n=66) by new maxillary and mandibular conventional dentures. For the primary outcome of the study, general satisfaction was measured by visual analogue scales (0 to 100) for maxilla and mandibular. The secondary outcomes were quality of mastication function, oral health related quality of health by OHIP oral health impact profile, mini nutritional assessment, and anthropometric measurement. These were gathered at pretest, post 1 month, post 3 months and post 6 months treatment. Blood parameters such as serum albumin, plasma B12, serum and erythrocyte folate, serum Iron, red blood cells, haemoglobin, and total lymphocyte counts were tested at pretest and post 6 months assessment. Data were gathered by a dietitian and a trained public health nurse, who were blind to research protocol. Weight and height was measured by stadiometer (DETECTO, donated by UNICEF), we measured to the nearest 100gm, with light clothing and without shoes. Waist and hip circumferences were measured with nonelastic tape. From height and weight, the Body Mass Index was calculated. A Lange caliper was used for skin fold thickness (SFT) measurements by two persons (a trained dietitian and public health nurse), and from their measurement in each person, within 1 mm were averaged. The skin fold thickness was measures at dominant side of body at biceps, triceps, subscapular, abdominal and iliac crest area. Body fat percentage (BFAT %, SFT) and Lean Body Mass were calculated by Durnin & Womersley calculation (Durnin and Womersley, 1974). Past seven days daily dietary intake was also collected at pretest, post 1 month, post 3 months, and post 6 months. Instruments for data collection: the questionnaires used for data collection were as follows; (1) For oral health related quality of health by OHIP 20 Thai version already adopted (John et al., 2006), translated and used in King Project “Project Dental Implant Honor”. (2) Quality of mastication function (QMF) adopted from original English language was translate to Thai by researcher (3) Mini Nutritional Assessment (MNA) (Guigoz Y et al., 1996) was adopted and translated to Thai by researcher 796 J. Med. Med. Sci. NEED Workshop I Objective To give information of nutrients and nutrients portion Content Introduction of NEED Nutrient portion Nutrient sheets Thai Food pyramid Isometric exercise Workshop II To specify and select daily food counting and serving Food counting Shopping game Food serving Calculating food game Isometric exercise Workshop III To compare and apply correct daily healthy foods intake serving Twenty eight days food plan Food choice Dental care in dental prosthesis Diet consultation for systemic diseases Isometric exercise (4) VAS (McDowell I et al., 1996), visual analogue satisfaction score maxilla and mandibular (VASMX, VASMD) was adopted and translated by researcher. Regarding the IOD surgery and NEED programme were mentioned in Box 1. The Ethical Review Committee for research involving human research subjects, Health Science group, Chulalongkorn University, Thailand, had approved and the study title number is 037.2/53. Material & Methods Power point presentation Nutrients paper sheets Flipcharts Small group discussion Post assessment questionnaires Power point presentation Shopping games Food model Papers, Markers, Pen Small group discussion Post assessment questionnaires Power point presentation Photos, food models Food choice, mixer game Papers, Markers, Pen Small group discussion Post assessment questionnaires All data were entered into the Epidata version 3.1 programs and then transfer into SPSS statistical software and analyzed in SPSS Statistical software 17.0. Firstly, general characteristics among four groups were test by chi-square test and ANOVAs for comparability. Then, data analysis was done by applying descriptive and inferential statistics. For descriptive statistics; frequency, percentage, mean and standard deviation was used to describe the general characteristics of participants. For Suriyan et al. 797 Edentulous patients 65-83 years N=132 Male= 51, Female= 81 Excluded 4 senior edentulous persons 2, maxilofacial carcinoma with radiotherapy 1, retroviral infection with active pulmonary tuberculosis Pt rating(Satisfaction, OHQOL, QMF) Anthropometric measurements Blood parameters Food diaries 1, uncontrolled type 2 Diabetes with endstaged renal failure Random allocation IODNEED N=33 IOD N=33 CDNEED N=33 CD N=33 Female=16, Male=17 Female=25, Male=8 Female=19, Male=14 Female=21, Male=12 Pretest Post 1 month Post 3 months IODNEED N=33 IOD N=33 CDNEED N=32 CD N=33 Post 6 months Female=16, Male=17 Female=25, Male=8 Female=18, Male=14 Female=21, Male=12 Dropout (Expired) Female=1 OHQOL: oral health related quality of health QMF: quality of mastication function within-group data, compared between before and post 6 months in each group, paired t -tests were performed. Comparison among groups, scores were compared by one way ANOVA and if there was difference among four groups, was analyzed by post-hoc test to know exactly between which groups, and for equal variances Bonferoni was used and in case of equal variance was not assumed the Dunnett T3 was used. Comparing among the timing of measurements (pretest, post one month, post three months and post 6 months) and among the four studied groups were analyzed by general Linear Model, repeated measures. If in case of among groups, equal variance was not assumed the Kruskal Wallis Test was used. Cost-effective was analyzed by correlation and regression. For nonparametric data, within groups was tested by Wilcosin sign-rank test and among groups was by Kruskal-Wallis test. RESULTS According to inclusion criteria, one hundred and thirty two participants (81 female and 51 male) were initially randomized into the study. There were 33 participants in each group at baseline. All of the participants attended post one month, post 3 months, post 6 months follow-up appoints except one female expired in CDNEED group due to motorcycle accident (Figure 1). The research results found that all general characteristics were not statistically significant difference among the four groups; “IODNEED”, “IOD”, “CDNEED”, and “CD" (p-value > .05). Mean scores of pretest OHIP, QMF, VASMX, BMI, BFAT% (SFT), LBM, daily diet intake, most of the blood parameters were not significant different among the four groups (p-value > .05). Except IODNEED group had significant lower mean scores in VASMD and MNA than CD and CDNEED group. Moreover, IODNEED group had significant higher mean scores in Serum albumin, Serum Fe and RBC (p-value < 0.05). As for description of mean and standard deviation of sum of scores of oral health related quality of life (OHIP and QMF), satisfaction scores VASMX and VASMD, nutritional status MNA and BMI among the four groups were elicited in Table 1. It can be seen that in IODNEED group had from time to time improvement of mean scores in all variables and higher than the others. Comparison of the mean scores within group, categorized by oral health impact profile (OHIP), quality of mastication (QMF) , satisfaction for maxilla (VASMX) , satisfaction for mandibular (VASMD), pretest and post 6 months intervention, there had higher mean scores in all four groups (p-value .001) but the best improvement of mean difference was seen in IODNEED group (Table 2). 798 J. Med. Med. Sci. Table 1. Descriptive statistics of OHIP, QMF, VASMX, VASMD, MNA and BMI till post 6 mos appointment Variables OHIP QMF VASMX VASMD MNA BMI IOD NEED Mean ± SD 75.1818±19.1449 101.3030±12.1591 IOD Mean ± SD 75.9394±18.0311 98.1515±12.1838 CD NEED Mean ± SD 81.7576±14.2281 91.3939±13.9462 CD Mean ± SD 81.5455±15.3401 88.8182±11.1256 105.5455±8.9620 110.4242±5.6956 108.4848±8.1590 109.5152±7.4335 96.5000±14.0919 96.9688±13.9734 92.0303±10.7746 92.2424±10.8398 68.3333±20.1117 100.606±16.5245 67.8182±17.2526 96.9697±14.7574 75.9697±16.7919 83.0909±14.0809 70.3030±15.4161 80.6364±11.5402 112.4545±13.0098 116.7576±10.5713 114.9091±12.3374 117.0303±11.0439 87.2813±14.8720 88.6875±13.9964 83.0909±11.1869 89.7879±10.5260 561.788±125.3179 682.879±63.9339 550.768±115.732 651.061±64.563 605.7576±85.1022 635.0000±76.6995 553.7879±79.2842 604.0909±67.5631 686.9697±66.9149 688.9394±64.3933 668.3333±66.9149 668.1818±67.2660 660.3125±67.8463 658.2813±70.4320 603.3333±69.7167 602.4242±67.2591 488.333±117.0781 684.546±58.1399 472.727±96.007 647.273±78.522 557.1212±100.078 596.0606±91.8623 509.6970±85.5948 569.3939±74.6843 699.8485±66.7725 721.8182±48.9231 670.3030±82.7169 702.8788±51.1742 618.1250±91.0047 620.1563±84.9714 557.8788±70.1230 558.0303±68.4076 24.5606±3.5416 27.9848±1.9704 26.3182±2.9257 27.6818±2.5459 26.1970±2.3517 27.7879±1.9962 26.7727±2.5803 28.0000±2.6428 28.5000±1.7321 28.8485±1.3721 28.4545±2.1879 28.6212±1.8583 28.0938±1.9528 28.1719±1.7808 27.6061±2.7436 27.6970±2.5798 24.3864±4.1260 24.8667±4.2778 23.7688±5.3477 24.3876±5.2485 24.9100±4.1289 25.4470±3.7145 25.1242±4.0957 24.8755±3.8426 25.3242±4.2842 25.8073±4.0734 24.6685±5.2447 25.1464±4.8420 25.6809±3.7588 25.8650±3.3889 25.1645±3.7179 25.2448±3.6540 TIMING Pretest 1 month 3 months 6 months Pretest 1 month 3 months 6 months Pretest 1 month 3 months 6 months Pretest 1 month 3 months 6 months Pretest Post 1 mo 3 months 6 months Pretest Post 1 mo 3 months 6 months OHIP: Oral Health Impact Profile QMF: Quality of Mastication Function VASMX: Visual Analogue Satisfaction Score for Maxilla VASMD: Visual Analogue Satisfaction Score for Mandibular MNA: Mini Nutritional Assessment BMI: Body Mass Index Table 2. Comparison of sum of scores between pretest and post 6 months within group (Paired t-test) OHIP M diff a b p-value QMF M diff a b p-value VASMX M diff a b p-value VASMD M diff a b p-value a b IODNEED -35.2424 IOD -33.5758 CDNEED -15.750 CD -10.697 < .001 < .001 < .001 < .001 -48.4242 -49.2121 -13.219 -19.485 < .001 < .001 < .001 < .001 -127.1515 < .001 -117.4242 -55.000 -48.636 < .001 < .001 < .001 -233.4849 -230.1515 -65.156 -48.333 < .001 < .001 < .001 0.001 Mean difference Sig. (2-tailed) Regarding nutritional (MNA, DIET, DIETITEM) and anthropometric (BMI, BFAT% SFT, LBM) assessments, within group pretest and post 6 months intervention, significant higher mean differences were found in IODNEED and CDNEED group, of the variables MNA, daily dietary intake and BMI (p-value < .03). Moreover, BFAT% (SFT) was non-significant lower in IODNEED and CDNEED group (p-value >.05). On the other hand, Suriyan et al. 799 Table 3. Comparison of sum of scores between pretest and post 6 months within group (Paired t-test) IODNEED -4.2879 IOD CDNEED CD -2.3030 -1.922 -0.924 p-value < .001 < .001 < .001 0.105 M diffa -86.3636 -16.6667 -65.6250 -18.1818 p-value <.001 .2270 .0020 .1120 DIETITEM M rankc 16.50 7.86 12.13 8.88 <.001 0.496 0.001 0.082 -1.4209 -1.3776 -0.961 -0.121 p-value < .001 < .001 .029 .731 a .7606 -1.6818 .3094 -.5636 0.635 0.203 0.584 0.343 -2.6667 -.8636 -1.6094 .1455 0.219 0.726 0.012 0.802 MNA M diff a b DIET b d p-value BMI M diff a b BFAT% M diff b p-value LBM M diff a b p-value a c Mean difference Mean rank b Sig. (2-tailed) d Wilcoxon Signed Ranks Test, Asymp. Sig (2-tailed) DIET: Average mean score of seven days daily diet intake (Calories) DIETITEM: 5 Items of Diet such as protein, carbohydrate, fat, fruits and vegetables (mixed healthy diet) BFAT% (SFT) was -significant increase in IOD and CD group (p-value >.05) (Table 3). Within group comparison of the mean scores of seven items of blood parameters between pretest and post 6 months intervention, significant higher mean differences were found in six out of seven items in IODNEED group (p-value < .015) and three out of seven items in CDNEED group (p-value < ..215). Moreover, the highest mean score differences were seen in IODNEED group (Table 4). Regarding the comparison among groups after post 6 months intervention, General linear model repeated measures was used to analyzed the different among timing of measurements (pretest, post 1 month, post 3 months and post 6 months) and among the four groups (4 ˣ 4 factors) for the variables OHIP, QMF, VASMX, VASMD, MNA and BMI. Moreover, Univariate ANOVA was used for daily nutritional intake, BFAT% (SFT), LBM, and blood parameters. The results were shown in (Table 5). (i) comparison between “IODNEED” group and “IOD” group, there had significant lower mean score of BFAT% (SFT), significant higher mean scores of daily diet intake and 4 out of 7 blood parameters in IODNEED group (p-value< .05). (ii) comparison between “IODNEED” group and “CDNEED” group, “IODNEED” group had significant higher mean score in OHIP, QMF, VASMD, and 4 out of 7 blood parameters than “CDNEED” group (p-value< .02). (iii) comparison between “IODNEED” group and “CD control group”, “IODNEED” group had significant higher mean score in OHIP, QMF, VASMX, VASMD, 6 out of 7 blood parameters than “CD control group” (p-value< .016). (iv) comparison between “IOD” group and “CDNEED group”, “IOD” group had significant higher mean score in OHIP, QMF, and VASMD than “CDNEED group” (p-value< .001). (v) comparison between “IOD” group and “CD control group”, “IOD” group had significant higher mean score in OHIP, QMF, VASMX, and VASMD than “CD control group” (p-value= .001). (vi) there had only significant higher mean score in satisfaction in CDNEED group than CD group (p-value= .007). (vii) mean scores in MNA, BMI, were not significant different among the groups after post 6 months intervention. The analysis of interview timing; pretest, post 1 month, post 3 months and post 6 months within the group: for OHIP and QMF, it was found that pretest mean score was significant lower than post 1 month, post 3 months and post 6 months (p-value <0.001). Whereas, post 1 800 J. Med. Med. Sci. Table 4. Comparison of sum of scores between pretest and post 6 months within group (Paired t-test) Se albu IODNEED -.1152 IOD CDNEED CD -.0242 -.0875 .0121 <.001 .498 .025 .254 -91.3333 -3.8485 -.0938 35.7272 p-value <.001 .768 .992 .196 M diff a b p-value -3.2258 .2215 -.4866 .0046 <.001 .706 .022 .993 -9.2424 .6970 -2.5938 .5152 .015 .642 .189 .582 M diff a b p-value Pl B12 M diff a b Se folate Se Fe M diff a p-valueb RBC a -.1776 -.0655 -.0884 -.0103 p-value <.001 .090 .006 .429 a -.6515 -.1697 .0531 -.2152 <.001 .013 .848 .029 0.2727 -.8939 .3906 .7061 .848 .339 .773 .369 M diff b Hb M diff b p-value Lympho M diff a b p-value Serum albumin (g/L) Plasma B12 (pmol/L) Red blood cells ˣ10 Haemoglobin (g/L) Total Lymphocytes ˣ 109 Serum and erythrocyte folate (nmol/L) Serum iron (mmol/L) 12 a Mean difference Table 5. Pairwise comparisons among 4 groups for post 6 months(Summary). b Sig. (2-tailed) Suriyan et al. 801 Table 6. Correlation between Total cost and Oral Health Related Quality of Life Variables 2 P1 OHIP .380a 0.145 87.799 0.001 4.689 95% CI Lower 0.001 P3 OHIP .497 a 0.247 91.962 0.002 6.537 0.001 0.002 <.001 a 0.377 91.302 0.002 8.842 0.002 0.002 <.001 P6 OHIP R R .614 Constant b (slope) t p-value Upper 0.002 <.001 a Predictors: (Constant) Total cost 95% CI slope “b” month was significant lower from post 3 months and post 6 months (p-value <0.001) and also post 3 months was significant lower from post 6 months (p-value <0.001). Regarding the satisfaction score for mandibular, pretest was significant lower than post 1 month, post 3 months and post 6 months (p-value <0.001). Moreover, the post 1 month and post 3 months mean scores were significant lower from post 6 months (p-value <0.001). For MNA, pretest mean score was significant lower than post 1 month, post 3 months and post 6 months (p-value <0.001), and also post 3 months was significant lower from post 6 months (p-value <0.001). For BMI, there was no significant different between pretest and post 1 month mean scores but pretest mean score was significant lower than post 3 months and post 6 months (p-value <0.001), whereas, and post 1 month was significant lower from post 3 months and post 6 months (p-value <0.001) and also post 3 months was significant lower from post 6 months (p-value <0.001). Pairwise compairons within groups and among groups for MNA and BMI are shown in Figure 2 and Figure 3, respectively. From these figures, it can be seen that IODNEED group had better improvement of nutritional status from time to time. In IODNEED group, total cost for one person was combination of unit cost for dental implant with NEED program cost for one person (52 baths). In the IOD group, total cost for one person was the unit cost for dental implant only. Same as in CDNEED group, total cost for one person was combination of unit cost for conventional denture with NEED program cost for one person (52 baths) and in the CD group, total cost for one person was the unit cost for conventional denture only. The mean total cost in Thai Baths were in “IODNEED” group 9565.45±792.48, followed by “IOD” group 9091.18±479.25, in “CDNEED” group 1749.78±280.35 and “Control” group 1562.36±341.99. Regarding the analysis for cost-effectiveness in the time period of 6 months after post intervention, correlation between total cost and oral health related quality of life, it was revealed that, if cost 1000 Baths increase, there would have 1 score increased in one month post intervention, 2 scores increased in post three months intervention, and 2 scores increased in post six months intervention (p-value < .001). According to mean total cost in different studied groups, it could be calculated that the cost-effectiveness of “NEED” programme was (0.5 OHIP score) increased in “IODNEED” group than “IOD” group at one month post intervention, then (1 OHIP score) increased in “IODNEED” group than “IOD” group at three months post intervention. But there was no change in score increased at post 6 months intervention than from post 3 months, even though there had the stronger the linear relation between the two variables, as r=.614. Also, between CDNEED and CD group, the cost-effectiveness of “NEED” programme in CDNEED group was (0.2 OHIP score) increased at one month post intervention, (0.4 OHIP score) of OHIP increased at three months post intervention than CD group. But there was no change in score increased at post 6 months intervention than from post 3 months, even though there had the stronger the linear relation between the two variables, as r=.614 (Table 6). Similarly, the cost-effectiveness of “NEED” programme was (5.5 VASMD scores) increased in “IODNEED” group than “IOD” group at one month post intervention, then (6.5 VASMD scores) increased at three months post intervention. Moreover, (8 VASMD scores) satisfaction score for mandibular increased in “IODNEED” group than “IOD” group at six months post intervention (p-value <.001). Whereas, between CDNEED and CD group, (2.2 VASMD scores) increased in “CDNEED” group than “CD” group at one month post intervention, then (2.6 VASMD scores) increased at three months post intervention. Moreover, (3.2 VASMD scores) increased in “CDNEED” group than “CD” group at six months post intervention (pvalue < .001). From (Table 7), It could be concluded that (1) if cost 1000 Baths increase there would have (2 scores) increased in quality of mastication function in one month post intervention (2) if cost 1000 Baths increase there would have (4 scores) increase in satisfaction score for mandibular in three months post intervention (3) if cost 1000 Baths increase there would have (4 scores) increase in satisfaction score for mandibular in six months post intervention (p-value <.001). It could be calculated that the cost-effectiveness of “IOD” 802 J. Med. Med. Sci. Figure 2 Pairwise compairons for MNA Figure 3 Pairwise compairons for BMI Table 7. Correlation between Total cost and Quality of Mastication function Variables R2 R Constanta b (slope) t P1 QMF .525a 0.276 78.01 0.002 7.04 95% CI Lower 0.002 p-value P3 QMF a .733 0.538 79.72 0.004 12.295 0.003 0.004 <.001 P6 QMF .767a 0.589 83.58 0.004 13.598 0.003 0.004 <.001 Upper 0.003 <.001 a Predictors: (Constant) Total cost : 95% CI slope "b" programme and “CD” programme was (18 QMF scores) increased in “IOD” group and (3 QMF scores) increased in “CD” group at one month post intervention, then (36 QMF scores) increased in “IOD” group and (6 QMF scores) increased in “CD” group at three months post intervention. But there was no change in score increased at post 6 months intervention than post 3 months, even though there had the stronger the linear relation between the two variables, as r=.767 (Table 7). DISCUSSION The research results found that all general characteristics were not statistically significant difference among the four groups; (IODNEED), (IOD), (CDNEED), and (CD). It was the same results of other study in Canada (Morais J.A et al., 2003). Moreover, there were no different between “Before program scores” of the most of the variables among the four groups. Comparison of mean scores between pretest and after 6 months intervention in “IODNEED” group (Paired ttest), found: mean scores for OHIP, QMF, VAS for Maxilla, VAS for mandibular, MNA, BMI, Hip Circumference (HC), 6 out of 7 blood parameters such as serum albumin, plasma B12, Serum and erythrocyte folate, serum Fe, RBC, Hb were statistically significance higher than pretest. Moreover, lean body mass (LBM) was increased than pretest but there was no significant difference. It can be concluded that the senior persons can chew meat, fruits and vegetables. On the other hand, mean scores (BFAT%, SFT), skin fold thickness of biceps, triceps were no significant lower than pretest. It revealed that, the participants have knowledge and attitude to modify their diet especially not to eat saturated fat and intention to do light exercise such as regular walking, yoga and light body exercise for elderly (isometric exercise). Comparison of mean scores between pretest and after 6 months intervention in “IOD” group, found: mean scores for OHIP, QMF, VAS for Maxilla, VAS for mandibular, MNA, BMI, sub-scapular and abdominal skin fold thickness, HC, and Hb were statistically significance higher than pretest. On the other hand, there were no significant higher mean score of skin fold thickness (SFT) biceps, triceps, Waist Circumference (WC), BFAT%, LBM, serum albumin, plasma B12, Serum and erythrocyte folate, serum Fe, and RBC. It can be clearly seen that their skin fold thickness and body fat percentage were higher than pretest; increase in BMI would be due to body fat percentage. It was similar from the study that they concluded implant subjects had significant increases in the biceps, sub-scapular, and Suriyan et al. 803 abdominal skin-fold thickness measurements (Morais J.A et al., 2003). This revealed that effectiveness of surgery had a good achievement in only better mastication function but not increase in blood parameters and not effective on healthier distribution of adipose tissue. It can only be concluded that the senior persons can chew meat, fruits, nuts and vegetables. Our finding is similar to other studies; they reported that a significant number of those who received the implant overdentures reported that they had increased their intake of cheese, raw carrot, raw apple, nuts, and bacon (Allen and McMillan, 2002). Morais (Morais et al., 2003) confirmed that the provision of mandibular dentures supported by 2 implants increases food choice for individuals accustomed to wearing conventional dentures. They find it easier to consume hard, tough, and crisp foods, such as raw vegetables and fruits, as well as different types of meats. Comparison of mean scores between pretest and after 6 months intervention in “CDNEED” group, mean scores for OHIP, QMF, VAS for Maxilla, VAS for mandibular, MNA, BMI, LBM, 3 out of 7 of blood parameters such as serum albumin, Serum and erythrocyte folate, and RBC were statistically significance higher than pretest. And also there were no significant lower mean score of BFAT% (SFT) than pretest. This revealed that combined effect of new CD and nutritional empowerment have better achievement in oral health related quality of life, nutritional status and some of the blood parameters. In CD group, the results revealed that effectiveness of new CD had a good achievement in only better mastication function and oral health related quality of health but not increase in nutritional status, blood parameters and anthropometric measurement. It is the same result mentioned “there was good evidence that people adapt to tooth loss by altering their dietary intake to compensate for the increased difficulty of eating certain foods, even if masticatory function is restored with conventional dentures” (Wayler and Chauncey, 1983; Chauncey et al., 1984; Fontijn-Tekamp et al., 1996). Pairwise comparisons among 4 groups at Post 6 months assessment, the IODNEED group had the best significant outcomes mean scores not only oral health related quality of life, satisfaction and mastication but also nutritional status and blood parameters. Those finding proved that IODNEED program was better than IOD, CDNEED and CD. Moreover, the mean scores of oral health related quality of life, mastication function and satisfaction were also significantly higher in “IODNEED” group than “CD” group and “IOD” group than “CD” group. This could be concluded that effective of mandibular two implant-retained over dentures was more effective in terms of oral health related quality of life, mastication function and satisfaction than new conventional dentures. It was the same result with the study mentioned better post-treatment scores for the IOD than the CD group for general satisfaction (P<0.001) (Boerrigter et al., 1995), significant post-treatment between group difference in general satisfaction (P<0.005) (Thomason et al.,2003). Furthermore, comparison between IODNEED and CDNEED, there was significant higher mean scores in oral health related quality of life, satisfaction for mandibular and 4 out of 7 blood parameters. Thus, our finding filled the gaps of other findings “prosthetic rehabilitation in the absence of dietary counseling does not lead to dietary improvement” (Moynihan and Bradbury, 2001; Moynihan et al., 2006; Hildebrandt et al., 1997; Sahyoun et al., 2003; Sheiham et al., 2001). The results from comparisons among the timing of assessments (within groups) revealed that there was a steady increase in mean score of oral health related quality of health, mastication function and mini nutritional assessment from time to time. Regarding the mean scores of body mass index, it remain stable between pretest and post 1 month, then significant increase in post 3 months than pretest, and post 6 months than post 3 months. This revealed that the longer the post treatment duration the better improvement in BMI. The results also shown, there are positive correlations between cost and oral health related quality of life, satisfaction and mastication function. From the results of correlation and regression analysis of cost-effectiveness, it could be clearly seen that “NEED” program had a gradual improvement in terms of oral health related quality of health and clients’ satisfaction. From those, it can be concluded that “NEED” had not only improvement in mean scores of studied parameters but also effective by cost. Furthermore, positive correlation of cost and effective of quality of mastication was also seen between “IOD group and CD group” and there was 6 times improvement of masticatory function in IOD than CD, in our study. All of all, NEED program can improve nutritional status not only in mandibular two implant-retained overdentures but also in conventional dentures. RECOMMENDATION Regular participatory nutritional empowerment and isometric exercise should be provided in conjunction with mandibular two implant-retained overdentures in Thai senior edentulous citizens. Moreover, we have better to provide nutritional empowerment in conjunction with conventional dentures to whom in waiting lists or the person who not yet suitable for IOD. Lastly, one nutritionist should be empowered among the dental assistances in the dental team in each treatment unit. ACKNOWLEDGEMENT This study was supported by the Higher Education Research Promotion and National Research University project of Thailand, Office of the Higher Education 804 J. Med. Med. Sci. Commission (No. AS1148A). First of all, we would like to thank “THE 90th ANNIVERSARY OF CHULALONGKORN UNIVERSITY FUND” (Rachadaphiseksomphot Endowment Fund) for giving the research grant. Then, we would like to thank to all participants. Furthermore, we would like to express our appreciation and gratitude for College of Public Health Sciences, Chulalongkorn University, (King project) “Project Dental Implant Honor”, Prachatipat hospital, and BMA Bureau of Nutrition Bangkok for their supportive efforts in this study. Moreover, we also would like to thank to credential experts from “Project Dental Implant Honor”, Clinical Prof. Surachai Chaiwat, Department of Dental Surgery, Mahidol University, Assoc. Prof. Lertrit Sarinnapakorn, Department Dental Prosthodontics, Thammasart University, Thailand. Then, we also thank to Assoc. Prof. Dusit Sujirarat, Head of Department of Epidemiology, Faculty of Public Health, Mahidol University for giving statistical comments. Lastly, we extend our thanks to Dr. Kyaw Min (Physician), Ms. Vatcharaporn Yaemyeesuin (Public Health nurse), Dental assistance team in Prachatipat hospital for helping during intervention period and data collection. REFERENCES Allen PF, McMillan A (2002). Food selection and perception of chewing ability following provision of implant and conventional prostheses in complete denture wearers. Clin Oral Implants Res 3:320-326.) Awad MA, Locker D, Korner-Bitensky N, Feine JS (2000). Measuring the effect of intra-oral implant rehabilitation on health-related quality of life in a randomized controlled clinical trial. J Dent Res 79:16591663. Boerrigter, E.M., Stegenga, B., Raghoebar, G.M. & Boering, G. (1995) Patient satisfaction and chewing ability with implant-retained mandibular overdentures: a comparison with new complete dentures with or without preprosthetic surgery. The International Journal of Oral and Maxillofacial Surgery 53: 1167–1173. Chauncey HH, Muench ME, Kapur KK, Wayler AH. (1984). The effect of the loss of teeth on diet and nutrition. Int Dent J 34:98-104. Durnin JVGA, Womersley J. (1994). Body fat assessed from total body density and its estimation from skinfold thickness: measurements on 481 men and women aged from 16 to 72 years. Br J Nutrition. 32: 7797. Feine JS, Maskawi K, de Grandmont P, Donohue WB, Tanguay R, Lund JP. (1994). Within-subject comparisons of implant-supported mandibular prostheses: evaluation of masticatory function. J Dent Res 73:1646-1656. Fontijn-Tekamp FA, van 't Hof MA, Slagter AP, van Waas MA (1996). The state of dentition in relation to nutrition in elderly Europeans in the SENECA Study of 1993. Eur J Clin Nutr 50(Suppl 2):117-122. Geertman ME, Slagter AP, van't Hof MA, van Waas MA, Kalk W. (1999). Masticatory performance and chewing experience with implant-retained mandibular overdentures. J Oral Rehabil 26:7- 13. Greksa LP, Parraga IM, Clark CA (1995). The dietary adequacy of edentulous older adults. J Prosthet Dent;73:142-5. Guigoz Y, Vellas B, Garry PJ. (1996). Assessing the nutritional status of the elderly: the Mini Nutritional Assessment as part of the geriatric evaluation. Nutr Rev;54:59–65. Hartsook EI. (1974). Food selection, dietary adequacy, and related dental problems of patients with dental prostheses. J Prosthet Dent 32:32-40. Hildebrandt GH, Dominguez BL, Schork MA, Loesche WJ. (1997). Functional units, chewing, swallowing and food avoidance among the elderly. J Prosthet Dent;77(6):588-95. John MT, Slade GD, Szentpetery A, Setz JM (2006). Oral health-related quality of life in patients treated with fixed, removable and complete dentures 1 month and 6 to 12 months after treatment. Int J Prosthodont 17, 503-511. Joshipura KJ, Willett WC, Douglass CW. (1996). The impact of edentulousness on food and nutrient intake. J Am Dent Assoc 1996;127:459-67. King project, Dental implant honor report (2008). Department of Dental Institute, Ministry of Public Health, Thailand. McDowell I, Newell C (1996) Measuring health: a guide to rating scales and questionnaires. 2nd ed. New York: Oxford University Press; p. 341-5. Moynihan P, Butler TJ, Thomason JM, Jepson NJ. (2000). Nutrient intake in partially dentate patients: the effect of prosthetic rehabilitation. J Dent;28(8):557-63. Moynihan PJ, Bradbury J. Compromised dental function and nutrition. (2001). Nutrition ;17(2):177-8. Morais JA, Heydecke G, Pawliuk.J, Lund. J.P, Feine.J.S: (2003). The Effects of Mandibular Two implant Overdentures on Nutrition in Elderly Edentulous Individuals. J Dent Res 82(1):53-58. Papas AS, Palmer CA, Rounds MC, Russell RM. (1998). The effects of denture status on nutrition. Spec Care Dentist;18:17-25. Sahyoun N, Lin CL, Krall E. (2003). Nutritional status of the older adult is associated with dentition status. J Am Diet Assoc;103(1):61-6. Sheiham A, Steele JG, Marcenes W, Lowe C, Finch S, Bates CJ, Prentice A, Walls AW. (2001). The relationship between dental status nutrient intake, and nutritional status in older people. J Dent Res 80: 408e413. Thomason, J.M., Lund, J.P., Chehade, A. & Feine, J.S. (2003). Patient satisfaction with mandibular implant overdentures and conventional dentures 6 months after delivery. The International Journal of Prosthodontics 16: 467–473. Wayler AH, Chauncey HH (1983). Impact of complete dentures and impaired natural dentition on masticatory performance and food choice in healthy aging men. J Prosthet Dent 49:427-433. World Health Organization (1983). World oral health report, oral health to be part of the strategy for health for all, resolution WHA36.14.