| CTRI Number |
CTRI/2025/06/088528 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Healing with Different Sutures After Wisdom Tooth Removal
|
|
Scientific Title of Study
|
Comparative evaluation of hyaluronic acid impregnated mersilk, conventional mersilk and vicryl plus sutures following mandibular third molar 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 |
Amit B. Lall |
| Designation |
JUNIOR RESIDENT 1 |
| Affiliation |
SANTOSH DEEMED TO BE UNIVERSITY |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, SANTOSH DENTAL COLLEGE AND HOSPITAL, SANTOSH DEEMED TO BE UNIVERSITY, GHAZIABAD
K-64, K BLOCK, SECTOR-12, PRATAP VIHAR, GHAZIABAD
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
98910007011 |
| Fax |
|
| Email |
dr_abl@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit B. Lall |
| Designation |
JUNIOR RESIDENT 1 |
| Affiliation |
SANTOSH DEEMED TO BE UNIVERSITY |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, SANTOSH DENTAL COLLEGE AND HOSPITAL, SANTOSH DEEMED TO BE UNIVERSITY, GHAZIABAD
K-64, K BLOCK, SECTOR-12, PRATAP VIHAR, GHAZIABAD
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
9810007011 |
| Fax |
|
| Email |
abl_yahoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit B. Lall |
| Designation |
JUNIOR RESIDENT 1 |
| Affiliation |
SANTOSH DEEMED TO BE UNIVERSITY |
| Address |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, SANTOSH DENTAL COLLEGE AND HOSPITAL, SANTOSH DEEMED TO BE UNIVERSITY, GHAZIABAD
K-64, K BLOCK, SECTOR-12, PRATAP VIHAR, GHAZIABAD
Ghaziabad
UTTAR PRADESH
201009
India |
| Phone |
98910007011 |
| Fax |
|
| Email |
dr_abl@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, SANTOSH DENTAL COLLEGE AND HOSPITAL, SANTOSH DEEMED TO BE UNIVERSITY, GHAZIABAD |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Shraddha Sonwane |
Santosh Dental College and Hospital, Ghaziabad, Uttar Pradesh |
Department of Oral and
Maxillofacial Surgery, Santosh dental college, Santosh deemed to be university, Santosh nagar, sector 12, Block K, Pratap vihar, Ghaziabad, Uttarpradesh,201009.
Ghaziabad
UTTAR PRADESH |
9869134018
shraddhasonwane511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Santosh deemed to be university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients with ASA I and II requiring intraoral incisions and impacted third molar extraction |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional mersilk and vicryl plus sutures |
closure will involve the usage of Conventional mersilk and vicryl plus suture to achieve
hemostasis. |
| Comparator Agent |
Hyaluronic acid impregnated mersilk suture |
Following incision and 3rd molar extraction after achieving hemostasis, closure will involve HA impregnated 3-0 mersilk suture material within 10-20 minutes post surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
-Participants within the age group of 18 to 50 years.
-Patients requiring surgical removal of mandibular third molars.
-Willingness to comply with the postoperative care instructions and follow-up visits. |
|
| ExclusionCriteria |
| Details |
• Current use of medications known to affect wound healing, including corticosteroids or immunosuppressants.
• Patients not willing to participate in the study.
• Medically compromised like having diabetes, hypertension, pregnant females and anxious patients.
• Patients with a history of allergy to anesthetics or acute inflammation at the surgical site.
• Patients with existing oral infections or pericoronitis.
• Known allergy to local anesthetics or suture materials. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
A. Clinical Parameters
-Landry’s Healing Index (3rd and 7th day)
-Visual Analog Scale for pain and discomfort
-Clinician-rated suture handling and removal
B. Microbiological Parameters
Total CFU count on blood agar, chocolate agar, MacConkey agar
Bacterial species identification (e.g., Streptococcus, Lactobacillus) |
Post- operative day 1st, 3rd and 7th. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
30/06/2025 |
| 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="0"
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
|
Mandibular third molar extraction is a common oral surgical procedure frequently associated with postoperative complications such as pain, edema, trismus, hematoma, prolonged bleeding, pyrexia, and alveolar osteitis. These adverse effects can delay recovery and increase the risk of secondary infections and chronic pain. Sutures are critical in promoting wound stability and healing. This single-blinded, randomized controlled clinical trial aims to evaluate the efficacy of 1.5% hyaluronic acid (HA)-impregnated 3-0 mersilk sutures compared to conventional 3-0 mersilk and 3-0 Vicryl Plus sutures in mandibular third molar surgery. A total of 84 extraction sites will be randomly allocated into three equal groups (n=28): HA-impregnated mersilk (Group I), vicryl Plus (Group II), and conventional mersilk (Group III). Randomization will be conducted via coin flip, and outcome assessment will be blinded. Clinical wound healing will be evaluated using Landry’s Healing Index on postoperative days 1, 3, and 7. Microbial colonization will be assessed by colony-forming unit (CFU) counts, and pain levels will be measured using the Visual Analog Scale (VAS).The study hypothesizes that HA-impregnated mersilk sutures will demonstrate superior outcomes in wound healing, microbial control, and pain reduction. HA’s anti-inflammatory and antimicrobial properties may enhance tissue regeneration and minimize postoperative complications, potentially improving patient recovery and overall clinical outcomes. |