| CTRI Number |
CTRI/2024/08/072091 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Merits and demerits of antimicrobial mouthwashes in Gingivitis Cases |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of 0.2%Chlorhexidine and 0.1% Octanidine in Gingivitis Cases |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debarati Bhowmick |
| Designation |
Assistant Professor |
| Affiliation |
Dr. R.Ahmed Dental College and Hospital |
| Address |
Depatment of Periodontics
Dr. R.Ahmed Dental College and Hospital
114 AJC Bose Road, Kol-700014
West Bengal
Kolkata
WEST BENGAL
700014
India |
| Phone |
8597475989 |
| Fax |
|
| Email |
doctordebarati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debarati Bhowmick |
| Designation |
Assistant Professor |
| Affiliation |
Dr. R.Ahmed Dental College and Hospital |
| Address |
Depatment of Periodontics
Dr. R.Ahmed Dental College and Hospital
114 AJC Bose Road, Kol-700014
West Bengal
WEST BENGAL
700014
India |
| Phone |
8597475989 |
| Fax |
|
| Email |
doctordebarati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debarati Bhowmick |
| Designation |
Assistant Professor |
| Affiliation |
Dr. R.Ahmed Dental College and Hospital |
| Address |
Depatment of Periodontics
Dr. R.Ahmed Dental College and Hospital
114 AJC Bose Road, Kol-700014
West Bengal
WEST BENGAL
700014
India |
| Phone |
8597475989 |
| Fax |
|
| Email |
doctordebarati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. R.Ahmed Dental College and Hospital
114 AJC Bose Road, Kol-700014
West Bengal |
|
|
Primary Sponsor
|
| Name |
Dr. R. Ahmed Dental College and Hospital |
| Address |
Dr. R.Ahmed Dental College and Hospital
114 AJC Bose Road, Kol-700014
West Bengal
|
| Type of Sponsor |
Government medical college |
|
|
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 Debarati Bhowmick |
Department of Periodontics, Dr. R.Ahmed Dental College and Hospital |
Dr. R.Ahmed Dental College and Hospital 114 AJC Bose Road, Kol-700014 West Bengal
Kolkata
WEST BENGAL |
8240937773
doctordebarati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Dr R Ahmed Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients diagnosed with chronic gingivitis who are otherwise healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.2% chlorhexidine mouthwash |
Group B- 36 participants with 0.2% chlorhexidine twice daily for 21 days. PARAMETERS TO BE STUDIED: Plaque index , Sulcular bleeding index, gingival crevice depth, BP, local adverse effects Study intervals: At baseline (day 0), 21 days, 42 days post application |
| Intervention |
0.1% octenidine mouthwash |
Group C- 36 participants with 0.1% octenidine twice daily for 21 days. PARAMETERS TO BE STUDIED: Plaque index , Sulcular bleeding index, gingival crevice depth, BP, local adverse effects Study intervals: At baseline (day 0), 21 days, 42 days post application |
| Comparator Agent |
Control- 2% saline mouthwash |
Group A (Control)- 36 participants with 2% saline mouthwash twice daily (20ml) for 21 days. PARAMETERS TO BE STUDIED: Plaque index , Sulcular bleeding index, gingival crevice depth, BP, local adverse effects Study intervals: At baseline (day 0), 21 days, 42 days post application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
56.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with chronic gingivitis who are otherwise healthy
Patient willing to take part in the study and maintain appointment regularly.
|
|
| ExclusionCriteria |
| Details |
- Patients suffering from any other systemic diseases.
- Smokers and individuals with other oral habits.
- Pregnant or lactating mothers
- Patients who have received any antibiotics for the last three months
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The change in plaque and bleeding scores, and the variation in BP after using three mouthwashes between baseline and follow-up visits. |
42 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes were to evaluate the adverse events and changes in pulse pressure after using three mouthwashes from baseline to follow-up visits |
42 days |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
21/08/2024 |
| 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="3"
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
|
The clinical trial was designed to obtain ample
evidence about treatment effects by examining co-primary outcomes. The primary
outcomes were to assess (1) the change in plaque and bleeding scores, and (2)
the variation in BP after using three mouthwashes between baseline and
follow-up visits. The secondary outcomes were to evaluate the adverse events and
changes in pulse pressure after using three mouthwashes from baseline to
follow-up visits. The
endpoints included percentage reduction in plaque index and sulcus bleeding index, and local and systemic adverse events
|