| CTRI Number |
CTRI/2026/01/100206 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Chlorhexidine gel coated silk suture in wound healing after wisdom tooth removal |
|
Scientific Title of Study
|
comparative assessment of wound healing between incisions closed with conventional 3 0 silk suture and 3 0 silk suture coated with 0.2 percent chlorhexidine gel an in vivo 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 |
Hemamalini S |
| Designation |
Resident intern |
| Affiliation |
Tagore dental college and hospital |
| Address |
Department of oral and maxillofacial surgery room no 3 Tagore dental college and hospital Rathinamangalam
melakottaiyur post chennai 600127
Kancheepuram TAMIL NADU 600127 India |
| Phone |
7305504519 |
| Fax |
|
| Email |
hemamalinisureshkumar117@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Israel Nathaneal |
| Designation |
Associate professor |
| Affiliation |
Tagore dental college and hospital |
| Address |
Deparment of oral and maxillofacial surgery room no 3 Tagore dental college and hospital Rathinamangalam
Melakottaiyur post chennai 600127
Kancheepuram TAMIL NADU 600127 India |
| Phone |
93803363737 |
| Fax |
|
| Email |
israel@tagoredch.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Israel Nathaneal |
| Designation |
Associate professor |
| Affiliation |
Tagore dental college and hospital |
| Address |
Deparment of oral and maxillofacial surgery room no 3 Tagore dental college and hospital Rathinamangalam
Melakottaiyur post chennai 600127
Kancheepuram TAMIL NADU 600127 India |
| Phone |
93803363737 |
| Fax |
|
| Email |
israel@tagoredch.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hemamalini S |
| Address |
Tagore dental college and hospital Rathinamangalam
melakottaiyur post chennai 600127 |
| Type of Sponsor |
Other [self] |
|
|
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 Israel Nathaneal |
Tagore dental college and hospital |
Department of oral and maxillofacial surgery room 3 Kancheepuram TAMIL NADU |
93803363737
israel@tagoredch.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.2 percent chlorhexidine gel |
After the surgical removal of 3rd molar relieving incision closure done using 3-0 silk suture coated with 0.2 percent chlorhexidine gel.contact time is 7 days
0.2% chlorhexidine gel was prepared by diluting commercially available 2% chlorhexidine gel in a 1:9 ratio using a saline.
The dilution was performed under aseptic conditions using a sterile disposable 10-ml syringe without a needle by gently pushing and pulling the plunger several times.
The prepared gel was applied uniformly to the silk suture 2 hour prior to surgery.
|
| Comparator Agent |
3 0 silk suture |
after removal of 3rd molar releiving incision closed with 3 0 silk suture.standard care given |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
healthy patients aged 20-40 years
third molar region unilateral class 1 and 2 and position A and B
vertical and mesioangular impaction
patient willing to participate in the study
patient posted for surgical removal of mandibular 3rd molar |
|
| ExclusionCriteria |
| Details |
patient with systemic disease affecting wound healing
patient allergic to chlorhexidine
infected or contaminated surgical site
patient not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of wound healing of the surgical site and pain using a standardized wound healing index at specified postoperative intervals |
wound healing was assessed on day 1 day 3 day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| swelling |
day1,day3,day7 |
|
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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)
|
19/01/2026 |
| 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="0" Months="0" Days="1" |
|
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
Modification(s)
|
This study is randomized clinical trial designed to compare wound healing following surgical extraction in incision closure using conventional 3 0 silk suture and 3 0 silk sutures coated with chlorhexidine gel. A total of 54 participants will be randomly allocated into two groups. In the intervention group surgical wounds will be closed using 3 0 silk sutures coated with 0.2 percent chlorhexidine gel. In the control group wound closure will be done using conventional 3 0 silk sutures. Wound healing will be assessed using a standardized wound healing index Landry’s healing index on day 1 and postoperative day 3 and 7.The data collection will be done for 3 weeks. The study aims to evaluate the effectiveness of chlorhexidine coated silk sutures in improving wound healing outcomes. |