| CTRI Number |
CTRI/2025/06/089678 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of resveratrol in healing after third molar removal |
|
Scientific Title of Study
|
Therapeutic impact of resveratrol on healing and inflammation following mandibular third molar extraction - a randomized controlled study |
| Trial Acronym |
Therapeutic impact of resveratrol on healing and inflammation following mandibular third molar extraction - a randomized controlled study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dameesah Jan |
| Designation |
Student |
| Affiliation |
Manav Rachna Dental College |
| Address |
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Department of oral surgery
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Department of oral surgery
Faridabad
HARYANA
12104
India |
| Phone |
7889942524 |
| Fax |
|
| Email |
dameesah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Bhagat |
| Designation |
Profossor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Department of peal surgery
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Department of oral surgery
Faridabad
HARYANA
121004
India |
| Phone |
9953784571 |
| Fax |
|
| Email |
nitinbhagat.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Bhagat |
| Designation |
Profossor |
| Affiliation |
Manav Rachna Dental College |
| Address |
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Department of oral surgery
Faridabad
HARYANA
121004
India |
| Phone |
9953784571 |
| Fax |
|
| Email |
nitinbhagat.sds@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College |
|
|
Primary Sponsor
|
| Name |
CTRI |
| Address |
New delhi |
| Type of Sponsor |
Research institution |
|
|
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 |
| MRDC |
Manav Rachna dental College |
Plot A, Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Faridabad
HARYANA |
01294259000
dameesah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
“Role of Resveratrol in Accelerating Postoperative Recovery After Surgical Extraction of Impacted Mandibular Third Molars: A Randomized Clinical Trial” |
Randomised controlled clinical study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1.Patients aged between 18 and 40 years.
2.Indicated for surgical extraction of a single impacted mandibular third molar (mesioangular, horizontal, or vertical impaction).
3.Systemically healthy individuals (ASA I or II).
4.Patients willing to participate and able to provide written informed consent.
5.Patients with no history of allergy to Resveratrol or any components of the formulation used.
6.Patients available for follow-up and compliant with postoperative instructions. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1.Patients with systemic conditions that may affect healing (e.g., diabetes mellitus, immunocompromised states).
2.Current or recent use (within the past 2 weeks) of anti-inflammatory, antioxidant, or immunosuppressive medications.
3. History of hypersensitivity or allergy to Resveratrol or related compounds.
4. Pregnant or lactating women.
5. Active infection or pathology at the surgical site.
6.History of alcohol or substance abuse.
7.Patients with poor oral hygiene or active periodontal disease near the surgical sites
8.Smoking or tobacco use in any form.
9.Participation in another clinical trial within the last 30 days. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain reduction assessed by Visual Analog Scale (VAS) on postoperative Day 1, Day 3, and Day 7.
Swelling measured by linear facial measurements on Day 1, Day 3, and Day 7.
Trismus assessed by maximum interincisal mouth opening on Day 1, Day 3, and Day 7. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes:
Quality of wound healing assessed clinically using a standard wound healing index on Day 7.
Incidence of postoperative complications such as infection, dry socket, or delayed healing.
Adverse effects or any hypersensitivity reactions related to Resveratrol. |
6 to 12 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
14/07/2025 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 will be a randomized, double-blind, placebo-controlled, parallel-group clinical trial conducted to evaluate the role of Resveratrol in accelerating postoperative recovery following the surgical extraction of impacted mandibular third molars. |