BHARATI VIDYAPEETH DEEMED UNIVERSITY
-DENTAL COLLEGE AND HOSPITAL, PUNE
Synopsis of Proposed Research Project
Name of Postgraduate student: Dr. Jyotsana Khurana
 Subject: Periodontology
 Name of Postgraduate guide: Dr. Amita Mali
 Dissertation Title: Comparative evaluation of healing after periodontal flap
surgery using Iso Amyl 2-Cyanoacrylate (bioadhesive material) and silk sutures :
A split – mouth clinical study
 Brief resume of the proposed research:
A. Need for research:
After periodontal surgeries, the conventional method is to suture the wound and
let it heal by primary intention. Suturing requires time and good skills and
additional second visit for suture removal. To overcome these disadvantages, an
alternative to sutures, cyanoacrylate or tissue adhesive glue was introduced.
Amcrylate (Iso Amyl 2-Cyanoacrylate), the medical grade tissue glue, saves time
,is hemostatic and bacteriostaticand doesn’t need to be removed during postoperative follow-up . Hence it is a promising agent that can be used as an
alternative to the conventional suturing technique.
B. Review of literature:
1. Ashvini Padhye , Dilip G Pol conducted a study comparing the
clinical efficacy of cyanoacrylate as a bioadhesive material in
comparison to conventional silk sutures in modified widman flap
surgery, in the anterior region . They concluded that apart from the cost
effectiveness , cyanoacrylates were biologically well accepted by the
tissues and patient acceptance was far better as opposed to conventional
sutures.
2. Sudhinda Kulkarni , Vijay Dodwad , Vijay Chava conducted a
clinical and histological study on healing of periodontal flaps when
closed with silk sutures and cyanoacrylate.They found that healing with
cyanoacrylate is associated with less amount of inflammation and it
was concluded that cyanoacrylates aids in early initial healing.
3. C.P Giray ,A.Atasever, B.Durgan, K.Araz conducted a clinical
and electron
microscope comparison of silk sutures and
cyanoacrylate in human mucosa. The results demonstrate that
Histoacryl, as a tissue adhesive, is not cytotoxic in vivo and can be
used as an alternative to sutures in surgical procedures with its
haemostatic and bacteriostatic properties and its ability to isolate
wounds from food debris during the healing period. Moreover, its
ease of application shortens the operation time
C. Research objectives:
1. To evaluate and compare the healing after periodontal flap surgery using
amcrylate(Iso amyl-2-cyanoacrylate) with silk sutures by
1) Assessment of plaque index.
2) Assessment of sulcus bleeding index.
3) Assessment of depth of periodontal pocket.
4) Assessment of healing index.
2. To
evaluate
and
compare
the
subjective
criteria(pain/discomfort
,
burning/itching and acceptance by the subjects) and objective criteria (redness
,crater formation , material alba and displacement of suture) after
approximation of periodontal flap surgery using amcrylate(Iso amyl -2cyanoacrylate) with silk sutures.
D. Materials and Methods:
Source of data: A total of 20 subjects will be selected from those visiting the
Department of Periodontology,Bharati Vidyapeeth Dental college , Pune.
Inclusion criteria:
.
1) Subjects having moderate to severe periodontitis as
assessed by clinical criteria (i.e probing depth of
≥5mmand bone loss on radiograph ≥50% )in
consecutive 3 teeth at least in 2 quadrants.
2) Subjects between 20-50 years of age of both the sexes.
3) Subjects demonstrating acceptable oral hygiene prior
to surgical therapy
Exclusion criteria:
1. Known systemic diseases and/ or drug therapy which may
interfere with wound healing.
2. Known drug allergies to any of medications used in the
study
3. Patients with habits of smoking , tobacco chewing or any
other habit that might influence the disease or the treatment
4. Pregnant or lactating mother.
Study Protocol:
Subjects with chronic periodontitis measuring a pocket depth of≥5mm , indicated
for periodontal flap surgeries will be included in this study. An informed written
consent will be obtained from each subject. Mechanical subgingival debridement
will be carried out in all the subjects one month prior to the surgery. On the day of
the surgery ,before surgical procedure a short case history including
specificclinical parameters such as Plaque index (PI) (Turesky-Gilmore–
Glickman index), Sulcus bleeding index (Mulhemman and Son S) and Periodontal
probing depth will be recorded.The sites will be divided into two: Test sitewhere amcrylate will be applied after flap surgery and Control site-where 3-0 silk
suture will be given after periodontal flap surgery. Conventional flap surgery will
be performed under local anesthesia .Subjective and objective criteriawill be
recorded next day after surgery.Subjects will be recalled after 1 week for suture
removal and for recordingthe Plaque index, Healing index (Wachtel et
al).Subjects are again recalled after 2 weeks from baseline to re-record the
Healing index, and after 6weeks and 3 months to record thePlaque index , Sulcus
bleeding index and Periodontal probing depth.
Method of Data Analysis:
The data thus obtained will be subjected to statistical analysis.
Does the study require any investigation or intervention to be made on patients or
any other human or animals? Yes
 List of References
1. AshviniPadhya ,Dilip G Pol:clinical evaluation of the efficacy of N-butyl 2cyanoacrylate as a bioadhesive material in comparison to conventional silk
sutures in modified widman flap surgery in the anterior region. JIDA , Vol 5 , No.
8 , August 2011
2. SudhindraKulkarni ,VidyaDodwad , Vijay Chava:Healing of periodontal flaps
when closed with silk sutures and N- Butyl cyanoacrylate :A clinical and
histological study. Indian J Dent Res ,18(2),2007
3. C.B. Giray, A.Atasever, B.Durgan, K.Araz: Clinical and electron microscope
comparison of silk sutures and n - butyl -2 -cyanoacrylate in human mucosa.
4. W.H.Binnie ,J.O.Forrest : A Study of tissue response to cyanoacrylate adhesive
in periodontal surgery.J.Periodontal.August,1974
 Signature of the Student:
Remarks of the Guide:
Periodontal surgical procedures are routinely carried out for management of disease –
induced changes in the periodontal tissues .Close postoperative adaptation of the flap
onto the prepared root surface and the maintenance of this adaptation for a period of time
holds the key to the reestablishment of a healthy
dentogingivalunit.Amcrylate(cyanoacrylate or tissue glue) is a tissue adhesive , which
can be used for closure of the incised wounds to overcome the problems associated with
conventional suture materials like silk. The present study is designed to evaluate the
efficacy of Amcrylate assutureless wound closure in periodontal flap surgeries and
compare the results with the conventional suturing technique .
Name, designation and signature of the guide and head of department :
Dr. AmitaMali,
Professor & Head of Department of Periodontology
Participant Information Sheet
Title of Research: Comparative Evaluation of healing after periodontal flap surgery
usingof Iso Amyl 2-Cyanoacrylate (Bioadhesive Material) with Silk Sutures : A Split mouth clinical study
Name of Investigator: Dr. JyotsanaKhurana.
Research setting: Department of Periodontology,
BharatiVidyapeeth
Deemed
University Dental
College
and
Hospital, Pune.
Introduction of the proposed research:
Periodontal diseases are characterized by the presence of gingival inflammation,
periodontal pocket formation , loss of connective tissue attachment and alveolar bone
resorption around the affected teeth. Periodontal surgical procedures are routinely
carried out for the management of disease – induced changes in the periodontal tissues.
Several factors contribute to uneventful and healthy post operative healing. One very
important aspect is the closure of the periodontal flaps post surgery for attainment of a
primary union between the flap margins. Proper re-adaptation of these tissues over the
underlying structures so that micromovement is prevented during healing and maintains
the flaps in position until reattachment to the underlying tissues. To overcome the
disadvantages of sutures, an alternative , plastic adhesives were discovered in 1949 and
10 years later COOVER et al reported their use in surgical procedures.
Cyanoacrylate is adhesive compound characterized by their polymerization, in the
presence of water, into glue with high tensile and adhesive strengths. They are
characterized according to the length of the carbon chain. Amcrylate (the medical grade
tissue glue - Iso Amyl 2-Cynoacrylate, Manufactured by concord Drugs Ltd), dispensed
in ampules of 0.25, 0.50 and 1 ml can be used as an alternative to the conventional
suturing technique. It has several advantages over sutures in soft tissue injury : it saves
time , is hemostatic and bacteriostatic, and doesn’t need to be removed during post –
operative follow up , along with a few limitations like it delays healing due to the heat
produced if too thick an application is applied.
The proposed study will be comparing the efficacy of sutureless wound closure by
Amcrylate with conventional suturing technique. In this study amcrylate will be applied
to the periodontal flap on one region and sutures will be given on the other region.
You are being asked to participate in this research study .However , before you give
your consent to take part in this study , you must read and understand the following
explanation of the proposed study . It describes purpose , procedure and benefits of the
study . After you have read it , please feel free to ask any questions you may have . This
is to make sure you understand , what your participation in this study may involove ,
before you sign and date the consent form. Your participation in this study is voluntary .
The results of your samples will be kept confidential and used for the research only.
Purpose of this study:
To assess the efficacy of Amcrylate (iso amyl 2-cyanoacrylate) glue over the sutures in
periodontal surgery.
Procedure:
A complete history of your medical status will be recorded and complete periodontal
checkup will be carried out in the same appointment. You will be rendered thorough
scaling and polishing 1 month prior to the commencement of the study . You will be
advised to maintain oral hygiene. On the day of the surgery the clinical parameters will
be recorded. The surgery will be performed under local anesthesia .Flap will be raised ,
thorough debridement will be carried out. The flap will be sutured or adhered to the tooth
surface with the amcrylate glue. You will be given postoperative instructions and then
recalled on day 7 for suture removal and recording of the clinical parameter .The clinical
parameters will be re- recorded after 2 weeks , 6 weeks and 3 months from baseline .
Benefits of the study:
This study will help us evaluate the efficacy of amcrylate glue over the sutures in
periodontal flap surgeries.
Informed Consent
I confirm that I have read the participant information sheet on ____/____/____ or it has
been read to me, that I understand it, that I have had the opportunity to ask questions
about it, and that my questions have been answered to my satisfaction.
I have no objection to the bioadhesive material (amcrylate) being applied to the
periodontal flap on one region and silk sutures on the other region ,under LA after
surgery. I give my written consent to the operator and/or his co-worker for carrying out
flapsurgical procedure and clinical examination on the day of surgery, 2ndday,7thday , 14th
day , 6 weeks and 3 months after the surgery. I have also been informed about the
advantages and disadvantages of this material.
I have no objection to being a part of this study. The operator has promised to keep the
confidentiality of my personal records. I understand that my participation is voluntary
and I am free to withdraw at any time.
Name of the Participant: __________________
Signature or thumb impression: ________________
Date: _____________
Name of Researcher: Dr. Jyotsana Khurana
Signature: ________________
Date : ___________