| CTRI Number |
CTRI/2024/08/073108 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
25/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Curcumin versus metformin gel for treating gum disease : a randomized control trial |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of local administration of Curcumin gel and Metformin gel as an adjunct to non-surgical periodontal therapy– A 3-Arm parallel randomized control 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 |
Gauri Jayachandran |
| Designation |
PG student |
| Affiliation |
NITTE (Deemed to be University) AB Shetty Memorial Institute of Dental Sciences (ABSMIDS) |
| Address |
Department of periodontology
Ab Shetty Memorial Institute of dental sciences
Dakshina Kannada
KARNATAKA
575022
India |
| Phone |
7025620333 |
| Fax |
|
| Email |
j.gowrinair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gauri Jayachandran |
| Designation |
PG student |
| Affiliation |
NITTE (Deemed to be University) AB Shetty Memorial Institute of Dental Sciences (ABSMIDS) |
| Address |
Department of periodontology
Ab shetty memorial institute of dental sciences
Dakshina Kannada
KARNATAKA
575022
India |
| Phone |
7025620333 |
| Fax |
|
| Email |
j.gowrinair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gauri Jayachandran |
| Designation |
PG student |
| Affiliation |
NITTE (Deemed to be University) AB Shetty Memorial Institute of Dental Sciences (ABSMIDS) |
| Address |
department of periodontology
Ab Shetty memorial institute of dental sciences
Dakshina Kannada
KARNATAKA
575022
India |
| Phone |
7025620333 |
| Fax |
|
| Email |
j.gowrinair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontology
Ab Shetty Memorial Institute of Dental Sciences
Medical Sciences Complex,
Deralakatte, Mangaluru
Karnataka 575018
India
|
|
|
Primary Sponsor
|
| Name |
Dr Gauri Jayachandran |
| Address |
Department of periodontology AB SHETTY INSTITUTE OF DENTAL SCIENCES
Medical Sciences Complex,
Deralakatte, Mangaluru
Karnataka 575018
India |
| 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 Gauri Jayachandran |
Ab Shetty memorial institute of dental sciences |
Department of periodontology
Dakshina Kannada
KARNATAKA |
07025620333
j.gowrinair@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE A B Shetty Memorial Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individual with out any systemic disorders |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
curcumin gel |
during the first visit Scaling will be performed by ultrasonic scaler followed by SRP using specific Gracey Curettes After thorough SRP, Probing depth and clinical attachment level will be re-determined to avoid any discrepancy due to the presence of subgingival calculus followed by application of 2% curcumin gel delivered subgingivally and placement of Coe-Pak
Patients will be reevaluated for the clinical parameters at 1 month and 3 month |
| Comparator Agent |
Metformin gel |
at the first visit scaling will be performed by ultrasonic scaler followed by SRP using specific Gracey Curettes
After thorough SRP, Probing depth and clinical attachment level will be re-determined to avoid any discrepancy due to the presence of
subgingival calculus followed by the subgingival application of 1% Metformin gel. Patients will be reevaluated for the clinical parameters at 1 and 3 months |
| Intervention |
scaling and root planing (SRP) |
Scaling will be performed by ultrasonic scaler followed by root planing using specific Gracey Curette. After thorough SRP, Probing depth and clinical attachment level will be re-determined to avoid any discrepancy due to the presence of subgingival calculus. Clinical parameters will be evaluated at baseline. 1 month and 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18yrs of age
2. Systemically healthy patients with a minimum complement of 20 natural teeth
3. Probing depth (PD) ≤4mm
4. Clinical attachment level (CAL) 1-2mm
5. Less than 15% bone loss assessed radiographically
6. No history of periodontal therapy or use of antibiotics in the preceding 6 months |
|
| ExclusionCriteria |
| Details |
Subjects with known systemic disease;
2. Subjects with known or suspected allergy to the MF/biguanide group of drugs
3. Subjects who are allergic to curcumin in any form
4. Subjects on systemic MF for obesity
5. Patients who use tobacco in any form
6. Subjects who consume alcoholic
7. Subjects who are immunocompromised
8. Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Periodontal probing depth
Clinical attachment level |
baseline, 1 month and 3 moths |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index Modified Sulcular Bleeding index |
baseline, 1 month and 3 moths |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
19/09/2024 |
| 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="4"
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
|
Aim: This study is aimed to assess the efficiency of subgingivally delivered curcumin and
metformin gel as an adjunct to scaling and root planning in the treatment of stage 1 periodontitis
Objectives:
1. To evaluate the efficacy of topically applied curcumin as an adjunct to NSPT in the
treatment of stage 1 periodontitis
2. To evaluate the efficacy of topically applied metformin gel as an adjunct to NSPT in the
treatment of stage 1 periodontitis
3. To compare the efficacy of curcumin gel and metformin gel as an adjunct to NSPT in the
treatment of stage 1 periodontitis Clinical examination will be carried out and the baseline values prior to the procedure will be
recorded by a single calibrated examiner. Radiographic analysis will be done to diagnose stage 1
periodontitis.
A customized acrylic occlusal stent will be fabricated for each patient to fit over the selected
sites. Values will be recorded on a standardized form containing the demographic data of the
patient.
Scaling will be performed by ultrasonic scaler followed by SRP using specific Gracey Curettes
After thorough SRP, PPD was re-determined to avoid any discrepancy due to the presence of
subgingival calculus followed by the local drug application
In Group I, the area will be completely dried using an air syringe and isolated with cotton rolls
to prevent contamination from saliva.
The local drug delivery system consisting of 1% Metformin gel (10) will be placed in the
periodontal pockets by applicator tips or syringe with a needle attached to it
Coe-Pak will be used to cover the pocket to retain the material in the pocket, as well as to prevent
the ingress of oral fluids
In Group 2 the same procedure will be repeated and a local drug delivery system consisting of
2% curcumin gel will be placed in the periodontal pockets followed by Coe-Pak
In Group 3 only and scaling and root planing will be performed |