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CTRI Number  CTRI/2025/04/085906 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 25/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Silk Stitches and Surgical Glue in Gum Surgery: Which Works Better? 
Scientific Title of Study   Clinical Evaluation of Silk Sutures and Cyanoacrylate Tissue Adhesives in Periodontal Flap Surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Parveen Dahiya 
Designation  Professor 
Affiliation  Department of Periodontics and implantology Room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh 
Address  Department of Periodontics and implantology Room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh

Sirmaur
HIMACHAL PRADESH
173025
India 
Phone  9857373300  
Fax    
Email  parveen_132@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neharika Trehan 
Designation  Post Graduate student 
Affiliation  Department of Periodontics and implantology Room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh 
Address  Department of Periodontics and implantology Room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh

Sirmaur
HIMACHAL PRADESH
173025
India 
Phone  07833851030  
Fax    
Email  neharika.trehan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parveen Dahiya 
Designation  Professor 
Affiliation  Department of Periodontics and implantology Room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh 
Address  Department of Periodontics and implantology Room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh

Sirmaur
HIMACHAL PRADESH
173025
India 
Phone  9857373300  
Fax    
Email  parveen_132@yahoo.com  
 
Source of Monetary or Material Support  
Department of Periodontics and implantology Room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh District-Sirmaur pin code-173025 India 
 
Primary Sponsor  
Name  Dr Parveen Dahiya  
Address  Department of Periodontics and implantology Room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh District-Sirmaur pin code-173025 India 
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 Parveen Dahiya  Himachal Institute of Dental Sciences, Poanta Sahib,Himachal Pradesh.  Department of Periodontics and implantology Room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh District-Sirmaur pin code-173025 India
Sirmaur
HIMACHAL PRADESH 		 09857373300

parveen_132@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HIDS Institutional Ethics Committee  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 
Comparator Agent  ISO AMYL 2-CYANOACRYLATE  Iso Amyl 2- cyanoacrylate ampoule 0.25ml, Bio Adhesive for wound closure 
Intervention  Non absorbable Silk suture  3-0 U.S.P (2 metric) braided coated silk, non-absorbable suture 26mm 3/8 circle reverse cutting  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  pocket depth greater than 5mm 
 
ExclusionCriteria 
Details  patients with systemic diseases
uncooperative patients
smokers
patients with bleeding disorders
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
assess post operative healing  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
assess patient comfort  6 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   15/05/2025 
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 - NO
Brief Summary  

 The study aims to comparatively evaluate postoperative healing and patient comfort following Periodontal Flap Surgery using Silk Suture vs. Cyanoacrylate Tissue Adhesive. Inclusion Criteria includes individuals of age 25–50 years, pocket depth greater than or equal to 5 mm and bleeding on probing. Exclusion Criteria includes patients with systemic conditions such as diabetes, heart disease; uncooperative patients, smokers/tobacco users and patients with bleeding disorders. Methodology is Group I is for Silk sutures; Group II is for Cyanoacrylate adhesive. Parameters such as healing, comfort level, bleeding, swelling, eating discomfort, speech discomfort will be evaluated using OHIP-14, plaque Index and bleeding Index. Pain will be evaluated using using VAS (Visual Analogue Scale). Parameter assessment will be done at 7th day and1 month post-operatively.

 
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