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CTRI Number  CTRI/2024/02/062586 [Registered on: 13/02/2024] Trial Registered Prospectively
Last Modified On: 09/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assessment of wound healing in periodontal flaps closed using N-Hexyl cyanoacrylate and Isoamyl 2-cyanoacrylate glue 
Scientific Title of Study   Comparative evaluation of wound healing in periodontal flaps approximated with N-hexyl cyanoacrylate and Isoamyl 2-cyanoacrylate tissue adhesives – A clinico-histological study.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yogita Uttam Landge 
Designation  Postgraduate Student  
Affiliation  YCMM and RDFs Dental Collage and Hospital Ahmednagar 
Address  Room no.1, PG section, Department of Periodontics, YCMM and RDFs Dental Collage and Hospital, Vadgaon Gupta Road, Opposite to MIDC, Ahmednagar

Ahmadnagar
MAHARASHTRA
414003
India 
Phone  7038579850  
Fax  02412785111  
Email  yogitalandge12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nikesh Moolya 
Designation  Professor 
Affiliation  YCMM and RDFs Dental Collage and Hospital Ahmednagar 
Address  Room no.1, PG section, Department of Periodontics, YCMM and RDFs Dental Collage and Hospital, Vadgaon Gupta Road, Opposite to MIDC, Ahmednagar

Ahmadnagar
MAHARASHTRA
414003
India 
Phone  9987004390  
Fax  02412785111  
Email  drmoolya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Yogita Uttam Landge 
Designation  Postgraduate Student 
Affiliation  YCMM and RDFs Dental Collage Ahmednagar 
Address  Room no.1, PG section, Department of Periodontics, YCMM and RDFs Dental Collage and Hospital, Vadgaon Gupta Road, Opposite to MIDC, Ahmednagar

Ahmadnagar
MAHARASHTRA
414003
India 
Phone  7038579850  
Fax  02412785111  
Email  yogitalandge12@gmail.com  
 
Source of Monetary or Material Support  
YCMM & RDFs Dental Collage and Hospital Ahmednagar 414003 
 
Primary Sponsor  
Name  Yogita Uttam Landge 
Address  YCMM & RDFs Dental Collage and Hospital Ahmednagar 414003 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nilima Rajhans  Shri. Yashwantrao Chavan Memorial Medical & Rural Development Foundations Dental College & Hospital  Room no.1, Post-graduate surgical section, Department of Periodontics
Ahmadnagar
MAHARASHTRA 		 9860622850
02412785111
drnilimarajhans@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE YASHWANTRAO CHAVAN MEMORIAL MEDICAL AND RURAL DEVELOPMENT FOUNDATION S DENTAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  3-0 black braided silk suture  Periodontal flap approximation after periodontal flap surgery for 7 days 
Intervention  Isoamyl 2-cynoacrylate tissue adhesive  Periodontal flap approximation after periodontal flap surgery for 7 days 
Intervention  N-hexyl cynoacrylate tissue adhesive  Periodontal flap approximation after periodontal flap surgery for 7 days 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Chronic periodontitis subjects indicated for periodontal flap surgery. 
 
ExclusionCriteria 
Details  1. Subjects with any pre-existing pathology.
2. Subjects with systemic diseases which delays the healing, cardiovascular
diseases, poorly controlled diabetes, HIV, cancer, haemorrhagic disorders.
3. Subjects having history of drug allergy, food allergy or allergy to polymers in
cyanoacrylate, glues, tissue adhesives.
4. Pregnant or lactating women.
5. Subjects using tobacco (In any form).
6. Chronic use of antimicrobial, ant-inflammatory drugs and other medications 6
months prior to the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Wound healing index (Landry, Turnbull, and Howley index)
2. Pain score (Visual Analogue Scale)
3. Plaque index  		 7th day, 15th day, 1 month follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
Histological examination  7th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [yogitalandge12@gmail.com].

  6. For how long will this data be available start date provided 15-08-2024 and end date provided 31-07-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Background: Periodontal surgical procedures are carried out for management of disease induced changes in periodontium and regeneration of lost periodontal tissues. Conventional methods used for flap approximation such as sutures, may cause trauma during needle penetration while passing through the tissues and provide a “wick down” through which bacteria can gain access to the underlying tissues. N-Hexyl Cyanoacrylate is a hybrid tissue sealant which is an innovative technology used in mesh fixation and haemostasis in digestive, visceral & uro-gynecological surgeries and showed fast-acting tissue adhesive properties hence widely used in medical surgical procedures now a days. Also, Isoamyl-2-cyanoacrylate has been the most popular and common tissue adhesive that offers advantages such as immediate haemostasis, bacteriostatic proprieties, and rapid adhesion to soft and hard tissues.

Objectives: To evaluate and compare the clinical and histological healing of surgical sites approximated with N-hexyl cyanoacrylate, Isoamyl-2-cyanoacrylate as tissue adhesives and silk suture.

Materials & methods: Total 30 patients will be selected and divided into three study groups randomly, 10 of each group. Signed informed consent will be obtained from the patients. N-hexyl-cyanoacrylate, Isoamyl-2-cyanoacrylate and Silk sutures will be used to approximate flap following periodontal flap surgery for the group 1, 2 & 3 respectively. The clinical parameters will be recorded after an interval of 7 days, 15 days and 1 month which will be evaluated using Wound healing index (Landry, Turnbull, and Howley index), Pain score (Visual Analogue Scale) and Plaque index (Quigley Hein Index (Modified), 1970). Standardized gingival punch biopsies will be taken and histological examination will be performed on 7th day.

Statistical analysis: Data will be analysed statistically using appropriate software.

Expected outcomes: There is a great possibility of significant difference in wound healing of periodontal surgical sites approximated with N-hexyl-Cyanoacrylate than Isoamyl-2-Cyanoacrylate and silk sutures. 

 
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