| CTRI Number |
CTRI/2025/07/090908 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study Comparing a palnt based Gel and standard Gel for Treatment of Patients with Gum Disease |
|
Scientific Title of Study
|
Comparative Evaluation of Resveratrol Gel and Chlorhexidine
Gel as Adjuncts to Scaling and Root Planing in the Treatment of
Periodontitis: Randomized Controlled Trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arushi Lal |
| Designation |
1st year postgraduate student |
| Affiliation |
Jss dental college and hospital |
| Address |
Department of periodontology Room Number 9, JSS Dental College, front gate bannimantap, A layout, bannimantap , mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
09901941942 |
| Fax |
|
| Email |
arushilal103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman basavaraju |
| Designation |
Professor and head of the department of periodontology |
| Affiliation |
Jss dental college and hospital |
| Address |
Department of periodontology room number 9, jss dental college , front gate bannimantap, A layout, bannimantap , mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
9945551564 |
| Fax |
|
| Email |
sumanbv_72@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman basavaraju |
| Designation |
Professor and head of the department of periodontology |
| Affiliation |
Jss dental college and hospital |
| Address |
Department of periodontology room number 9, jss dental college , front gate bannimantap, A layout, bannimantap , mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
9945551564 |
| Fax |
|
| Email |
sumanbv_72@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| department of periodontology room number 9 , jss dental college and hospital mysuru karnataka india 570015 |
|
|
Primary Sponsor
|
| Name |
Jss dental college and hospital |
| Address |
Department of peridontology room number 9 , jss dental college and hospital , bannimantap , mysuru karnataka india 570015 |
| Type of Sponsor |
Other [private funding] |
|
|
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 Arushi lal |
Jss dental and college |
Department of periodontology room number 9, bannimantap , mysuru
Mysore
KARNATAKA |
09901941942
arushilal103@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jss dental college and hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine gel |
Currently used local drug delivery agent
Dose - 2mL
route is via the gingival pocket
duratio - will be applied once only |
| Intervention |
Resveratrol gel |
resveratrol a natural compound found in grape skins, peanuts, and berries, emerges
as a promising candidate due to its dual anti-inflammatory and antioxidative properties,
as well as its ability to support tissue regeneration.
Dose - 2mL
route is via the gingival pocket
duratio - will be applied once only |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with pocket depth equal to 5 to 6mm and or clinical attachment loss more than or equal to 4mm and angular bone loss more than or equal to 3 mm on
intraoral periapical radiographs with no history of periodontal therapy or 6 months were
included.
One site per patient will be evaluated in maxilla or mandible to justify interpatient
variation in clinical parameters, patient compliance and response to the drug
administered. |
|
| ExclusionCriteria |
| Details |
1. Patients with a known systemic disease;
2. Known or suspected allergy
3. with aggressive periodontitis;
4. who used tobacco in any form;
5. immunocompromised patients
6. Women suffering from breast, ovary and uterine cancer |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To formulate and evaluate the efficacy of Resveratrol gel as a local drug delivery system
as an adjunct to scaling and root planning for treatment of periodontitis. |
Data collection august 2025 to february 2026
first vist - scaling and root planing , application of gel , measurement of baseline data
second visit - 1 week after
removal of periodontal pack and checking oral hygiene maintenece
third visit after 3 months for immunological evaluation
fourth visit after 6 months for follow up and radiographic parameters
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 3 |
|
Date of First Enrollment (India)
|
07/10/2025 |
| 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="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
|
Effective pharmacological treatment of infections is consistently constrained by microbial
drug resistance, which calls for the development of new, powerful antimicrobial
treatments. Chlorhexidine gel has been used extensively as a local drug delivery agent in
periodontal treatment; nevertheless, its side effects, such as altered taste perception,
tooth discoloration, and possible irritation of the mucosa, have led to the search for safer
substitutes. Natural substances with the ability to circumvent microbial resistance pathways while
reducing adverse effects, such as resveratrol, have become attractive options. A well
researched plant phenol, resveratrol has strong anti-inflammatory, antioxidant, and
antibacterial qualities that make it a useful treatment for a range of illnesses. However, its low bioavailability and poor water solubility limit its therapeutic relevance.
Despite these difficulties, the benefits of resveratrol, including its high membrane
permeability and suitability for passive diffusion, make it particularly promising for
localized drug delivery. In periodontitis, resveratrol shows potential to reduce
inflammation, prevent oxidative stress, and promote tissue healing. This study aims to explore resveratrol’s therapeutic applications, emphasizing its ability to
be used as a new local drug delivery agent as an adjunct to scaling and root planing and
compare it with the standard drug being used currently (chlorhexidine gel). |