| CTRI Number |
CTRI/2025/04/084923 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative analysis of clinical outcomes using three different absorbable sutures in impacted third molar surgeries - Randomised control study |
|
Scientific Title of Study
|
Comparative analysis of clinical outcomes using polydioxanone, polyglecaprone 25 AND polyglactin 910 sutures in impacted third molar surgeries - Randomised control 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 |
Devyani Sharma |
| Designation |
Postgraduate student |
| Affiliation |
ITS DENTAL COLLEGE , HOSPITAL AND RESEARCH CENTRE GREATER NOIDA |
| Address |
First floor , room number 5 , 47 Knowledge park 3 , Greater noida , Uttar Pradesh 201310
First floor , room number 5 , 47 Knowledge park 3 , Greater noida , Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8800971506 |
| Fax |
|
| Email |
devyanisharma610@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Himanshu Bhutani |
| Designation |
HOD & Professor |
| Affiliation |
ITS DENTAL COLLEGE , HOSPITAL AND RESEARCH CENTRE GREATER NOIDA |
| Address |
First floor, room number 5 , 47 Knowledge park 3 , Greater noida , Uttar Pradesh 201310
First floor, room number 5 , 47 Knowledge park 3 , Greater noida , Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8076039385 |
| Fax |
|
| Email |
himanshubhutiani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DEVYANI SHARMA |
| Designation |
Post graduate student |
| Affiliation |
ITS DENTAL COLLEGE , HOSPITAL AND RESEARCH CENTRE GREATER NOIDA |
| Address |
First floor , room number 5 , 47 knowledge park 3 , Greater noida , Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8800971506 |
| Fax |
|
| Email |
devyanisharma610@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS Dental College , Hospital and Research Centre, Greater Noida , Uttar Pradesh ,India - 201310 |
|
|
Primary Sponsor
|
| Name |
ITS Dental College Hospital and Research Centre |
| Address |
47 Knowledge Park 3 Greater Noida 201310 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrDevyani Sharma |
ITS DENTAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
47 KNOWLEDGE PARK 3 GREATER NOIDA UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
8800971506
devyanisharma610@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE OF ITS DENTAL COLLEGE , HOSPITAL & RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Absorbable Knotless Barbed Suture |
Its a surgical suture that is barbed along its length , eliminating the need for traditional knots to secure the tissue.
Rate of absorption is 120 days |
| Comparator Agent |
Polyglactin 910 |
Commonly known as Vicryl , is a absorbable , synthetic usually braided suture .
Time: 60 to 90 days
|
| Comparator Agent |
Polyglecaprone 25 |
Also called as monocryl ,is a monofilamentous , synthetic absorbable surgical suture indicated for ligation after surgery.
Time : 45 to 90 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with at least one impacted mandibular third molar requiring surgical removal.
ASA Grade I and II
Willingness to abide and comply with the protocol requirement and visits for follow-up
|
|
| ExclusionCriteria |
| Details |
Medically compromised patients
Active pus discharge, infection at the operative site
Tobacco users
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcomes of the study will be:
Healing Time – Evaluating how quickly the surgical site heals with each suture type.
Infection Rates – Assessing the incidence of post-operative infections in each group.
Post-Operative Pain – Measuring pain levels using a standardized pain scale over a set period.
Swelling – Comparing post-operative edema across the three suture groups.
Patient Comfort – Assessing factors like irritation, tightness, or discomfort related to the suture material. |
at 3 days , one week , 10 days and 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Comfort – Assessing factors like irritation, tightness, or discomfort related to the suture material. |
at one week , & fifteen days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
30/04/2025 |
| 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="1"
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
|
This study aims to assess and compare the clinical outcomes of knotless barbed sutures, monofilament resorbable sutures, and resorbable multifilament sutures in impacted mandibular third molar surgeries, with focus on wound healing, infection rates, post-operative complications, and patient comfort. Through a randomized controlled trial, patients will be assigned to one of the three suture groups: knotless barbed sutures (Polydioxanone), monofilament resorbable sutures (Monocryl), or multifilament sutures (Vicryl). The primary outcomes include healing time, infection rates, incidence of post-operative pain, swelling, and overall patient comfort. Traditional sutures, such as Vicryl, are associated with higher infection risks due to their multifilament structure, which can harbor bacteria, and complications such as knot slippage, inadequate tension, or irritation. Monofilament sutures, while better at reducing bacterial colonization, still rely on knots, which can lead to tissue irritation and delayed healing. In contrast, knotless barbed sutures (Polydioxanone) offer a game-changing advancement by eliminating the need for knots, reducing surgical time, minimizing tissue irritation, and preventing complications like knot-related slippage or ischemia.. This study seeks to provide insights into the most effective suture materials, ultimately optimizing surgical outcomes, reducing complications, and enhancing patient satisfaction and comfort in third molar extractions. By addressing these critical issues, this research promises to improve clinical practices, reduce recovery time, and transform the patient experience . |