| CTRI Number |
CTRI/2025/05/086178 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare the effect of a special resveratrol-based nanofiber film placed in gum pockets, along with routine dental cleaning, in patients with long-term gum disease. |
|
Scientific Title of Study
|
Comparative Evaluation of Electrospun Resveratrol-Loaded Nanofibers as a Local Drug Delivery System Adjunctive to Scaling and Root Planing in the Treatment of Chronic Periodontitis: A Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maria Sharon velraj |
| Designation |
Post graduate |
| Affiliation |
Saveetha institute of medical and technical sciences |
| Address |
Department of Periodontics , Saveetha dental college and hospitals , Saveetha institute of medical and technical sciences
Chennai
TAMIL NADU
600077
India |
| Phone |
8124448902 |
| Fax |
|
| Email |
152305002.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arvina R |
| Designation |
Associate professor |
| Affiliation |
Saveetha institute of medical and technical sciences |
| Address |
Department of Periodontics , Saveetha dental college and hospitals , Saveetha institute of medical and technical sciences
TAMIL NADU
600077
India |
| Phone |
8124448902 |
| Fax |
|
| Email |
arvinar.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Maria Sharon velraj |
| Designation |
Post graduate |
| Affiliation |
Saveetha institute of medical and technical sciences |
| Address |
Department of Periodontics , Saveetha dental college and hospitals , Saveetha institute of medical and technical sciences
TAMIL NADU
600077
India |
| Phone |
8124448902 |
| Fax |
|
| Email |
152305002.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontics , Saveetha dental college and hospitals , Saveetha institute of medical and technical sciences |
|
|
Primary Sponsor
|
| Name |
Maria sharon V |
| Address |
Department of Periodontics, Saveetha dental college and hospitals , Saveetha institute of medical and technical sciences |
| Type of Sponsor |
Other [Self sponser ] |
|
|
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 Maria Sharon velraj |
Saveetha dental college and hospitals |
Department of Periodontics
Chennai
TAMIL NADU |
08124448902
152305002.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College- Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Only subgingival scaling and root planing is done . |
| Intervention |
Electrospun Resveratrol-Loaded Nanofiber
|
SRP followed by Electrospun Resveratrol-Loaded Nanofiber Film
- Applied subgingivally into periodontal pockets after scaling and root planing (SRP).
- Dosage/Form: Single application of nanofiber (standardized size and drug content per pocket).
- Frequency: One-time application immediately after SRP. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 25 to 60 years
2. presence of greater than or equal to 20 teeth
3. Probing depth greater than or equal to 5mm in at least 4 sites
4. Diagnosed with chronic periodontitis |
|
| ExclusionCriteria |
| Details |
1.Systemic illness
2. Antibiotics or periodontal treatment in past 6 months
3.Pregnancy/lactation
4.Allergy to resveratrol |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
eduction in probing pocket depth (PPD)
- Gain in clinical attachment level (CAL) |
Baseline, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bleeding on probing |
Bleeding on probing - Baseline, !month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
20/05/2025 |
| 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="3"
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 randomized controlled clinical trial aims to evaluate the effectiveness of electrospun resveratrol-loaded nanofibers as a local drug delivery system when used as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis. Participants will be divided into two groups: one receiving SRP with resveratrol nanofiber application, and the other receiving SRP only . The study will assess improvements in probing pocket depth (PPD) and clinical attachment level (CAL) as primary outcomes, along with changes in bleeding on probing (BOP), as secondary outcome. Assessments will be conducted at baseline, 1 month and 3 months. |