FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/04/107632 [Registered on: 06/04/2026] Trial Registered Prospectively
Last Modified On: 06/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Pain-Relieving Stitches on Reducing Pain After Gum Surgery. 
Scientific Title of Study   Ibuprofen-Coated Absorbable Suture for Post-Operative Pain Management in Periodontal Surgical Procedures: A Single-Blind Randomized Controlled Trial  
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 Rashi Jhanwar 
Designation  Post Graduate student 
Affiliation  Tatyasaheb Kore Dental College and Research Centre, Nave Pargaon 
Address  Department of Periodontology, Tatyasaheb Kore Dental College and Research Centre, Nave Pargaon

Kolhapur
MAHARASHTRA
416113
India 
Phone  9834516311  
Fax    
Email  rashijhanwar.rj55@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhijeet Shete 
Designation  Professor and HOD 
Affiliation  Tatyasaheb Kore Dental College and Research Centre, Nave Pargaon 
Address  Department of Periodontology, Tatyasaheb Kore Dental College and Research Centre, Nave Pargaon

Kolhapur
MAHARASHTRA
416113
India 
Phone  9325220496  
Fax    
Email  drabhijeetshete@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhijeet Shete 
Designation  Professor and HOD 
Affiliation  Tatyasaheb Kore Dental College and Research Centre, Nave Pargaon 
Address  Department of Periodontology, Tatyasaheb Kore Dental College and Research Centre, Nave Pargaon


MAHARASHTRA
416113
India 
Phone  9325220496  
Fax    
Email  drabhijeetshete@gmail.com  
 
Source of Monetary or Material Support  
Department of Pharmaceutical Quality Assurance Bharati Vidyapeeth, College of Pharmacy, Kolhapur Near Chitranagari, Kolhapur-416013 
 
Primary Sponsor  
Name  Dr Rashi Jhanwar 
Address  Department of Periodontology, Tatyasaheb Kore Dental College and Research Centre, Nave Pargaon  
Type of Sponsor  Other [Private dental college] 
 
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 Rashi Jhanwar  Private Dental College  Department of Periodontology, Tatyasaheb Kore Dental College and Research Centre, Nave Pargaon
Kolhapur
MAHARASHTRA 
9834516311

rashijhanwar.rj55@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee - TATYASAHEB KORE DENTAL COLLEGE AND RESEARCH CENTRE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Individuals having insufficient crown height.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Coated-Suture  Ibuprofen coated polyglactin 910 sutures 0.5-1mg per 5 cm suture. total suture length 14cm. 
Comparator Agent  Non-Coated Sutures  Non-coated polyglactin 910 sutures  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients who are clinically, radiographically and after through laboratory investigations are eligible for functional crown lengthening procedure with undisplaced flap involving 1 or 2 teeth
2. No existing Oro-facial pain.
3. Patient with age group of 15 to 65 years.
4. Systemically healthy patient.
5. No need for antimicrobial prophylaxis
 
 
ExclusionCriteria 
Details  1. Patients who have taken analgesic 7 days or less prior to beginning the study.
2. Patient who is a known case of allergy/ intolerance to ibuprofen.
3. Habit of tobacco consumption in any form.
4. Pregnant and lactating women.
5. Patients who refuse to provide written informed consent.
6. Patient undergoing orthodontic treatment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain  2hrs, 6hrs, 24hrs. 72hrs 
 
Secondary Outcome  
Outcome  TimePoints 
healing  3rd day, 7th day post-operative 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="15" 
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 3 
Date of First Enrollment (India)   21/04/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This study aims to evaluate the effectiveness of ibuprofen coated absorbable sutures in reducing postoperative pain after functional crown lengthening procedures. Postoperative pain following periodontal surgery is common and is usually managed with systemic non steroidal anti inflammatory drugs. However prolonged systemic use may lead to adverse effects and reduced drug availability at the surgical site. Local drug delivery through analgesic coated sutures may provide targeted pain relief while minimizing systemic complications.

The study is designed as a single blind randomized controlled clinical trial including 34 systemically healthy patients aged 15 to 65 years who require functional crown lengthening with an undisplaced flap. Participants will be randomly allocated into two groups. The test group will receive ibuprofen coated polyglactin 910 absorbable sutures, while the control group will receive non coated polyglactin 910 absorbable sutures. Pain will be assessed using a visual analogue scale at 2 hours 6 hours 24 hours and 48 hours after surgery. Healing will be evaluated using a healing index on the third and seventh postoperative days.

The primary objective is to determine whether ibuprofen coated sutures significantly reduce postoperative pain compared to conventional sutures. The secondary objective is to evaluate their effect on wound healing. The study hypothesizes that analgesic coated sutures will reduce postoperative pain without adversely affecting healing. The findings may contribute to improved localized pain management strategies in periodontal surgical procedures while reducing reliance on systemic analgesics.

 
Close