| 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
|
|
|
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
|
|
|
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. |