| CTRI Number |
CTRI/2024/09/074265 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Analysis of Satranidazole and Aloe Vera Gels in Local Drug Delivery for Chronic Periodontitis: A Randomized, Single-Blind Study |
|
Scientific Title of Study
|
Comparative evaluation of Satranidazole gel and Aloe-vera gel through local drug delivery system in the treatment of Chronic Periodontitis: A Randomized, Single-blind, Parallel group study |
| 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 Aadarsh Vikram Dhan |
| Designation |
Postgraduate Student |
| Affiliation |
Chhattisgarh Dental College and Research Institute |
| Address |
Department of Periodontology,
Chhattisgarh Dental College and Research Institute,
Sundra, Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9669966200 |
| Fax |
|
| Email |
dhanaadarsh776@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiroj Bagde |
| Designation |
Professor, Guide & H.O.D. |
| Affiliation |
Chhattisgarh Dental College and Research Institute |
| Address |
Department of Periodontology,
Chhattisgarh Dental College and Research Institute,
Sundra, Rajnandgaon
Sundra, Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9766105900 |
| Fax |
|
| Email |
hirojbagde8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aadarsh Vikram Dhan |
| Designation |
Postgraduate Student |
| Affiliation |
Chhattisgarh Dental College and Research Institute |
| Address |
Department of Periodontology,
Chhattisgarh Dental College and Research Institute,
Sundra, Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9669966200 |
| Fax |
|
| Email |
dhanaadarsh776@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chhattisgarh Dental College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Dr Aadarsh Vikram Dhan |
| Address |
Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon (C.G.) 491441 |
| 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 Aadarsh Vikram Dhan |
Chhattisgarh Dental College and Research Institute |
Department of Periodontology
Rajnandgaon
CHHATTISGARH |
09669966200
dhanaadarsh776@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhattisgarh Dental College Ethical 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 |
Aloe vera |
Aloe vera extracted from the leaves of Aloe vera plant and formulated into a gel as a local drug delivery administration for a total duration of intervention of 1 month. |
| Intervention |
Satranidazole |
Satranidazole tablet 300mg dispersed to formulate a gel as a local drug delivery administration for a total duration of intervention as 1 month. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with mild to moderate chronic periodontitis.
2. Pocket depth of 4-6mm
3. No history of antibiotic or periodontal therapy in the previous 6 months
|
|
| ExclusionCriteria |
| Details |
1. Patients taking medications that could affect their periodontal health
2. Known allergy to herbal products/medications
3. Receiving systemic antimicrobial therapy
4. Patients with aggressive periodontitis
5. Patients with adverse habits
6. Pregnant, or nursing females |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing pocket depth, bleeding index |
Baseline & 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| gingival index and plaque index |
baseline and one-month |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 4 |
|
Date of First Enrollment (India)
|
16/10/2024 |
| 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="2" |
|
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
|
the study compares two drugs, satranidazole gel and aloe vera gel, in the form of local drug delivery in patients of chronic periodontitis, along with scaling and root planing. the primary outcome measures are probing pocket depth and bleeding index. the secondary outcome measures are plaque index and gingival index. the follow up will be done at baseline and one month. the result will be compared using appropriate statistical analysis |