| CTRI Number |
CTRI/2021/08/036056 [Registered on: 31/08/2021] Trial Registered Prospectively |
| Last Modified On: |
26/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
New Herbal Mouthwash for Oral Hygiene |
|
Scientific Title of Study
|
Assessment of Clinical Efficacy of New Herbal Oral Hygiene Rinse in Reducing Gingivitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Bhandari |
| Designation |
Head |
| Affiliation |
Institute of Nuclear Medicine and Allied Sciences |
| Address |
Brig S K Mazumdar Marg
Timarpur
North West
DELHI
110054
India |
| Phone |
|
| Fax |
|
| Email |
amitbhandari1093@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Bhandari |
| Designation |
Head |
| Affiliation |
Institute of Nuclear Medicine and Allied Sciences |
| Address |
Brig S K Mazumdar Marg
Timarpur
DELHI
110054
India |
| Phone |
|
| Fax |
|
| Email |
amitbhandari1093@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Bhandari |
| Designation |
Head |
| Affiliation |
Institute of Nuclear Medicine and Allied Sciences |
| Address |
Brig S K Mazumdar Marg
Timarpur
DELHI
110054
India |
| Phone |
|
| Fax |
|
| Email |
amitbhandari1093@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Nuclear Medicine and Allied Sciences |
|
|
Primary Sponsor
|
| Name |
Institute of Nuclear Medicine and Allied Sciences |
| Address |
Brig S K Mazumdar Marg
Timarpur |
| Type of Sponsor |
Research institution |
|
|
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 Amit Bhandari |
Institute of Nuclear Medicine and Allied Sciences |
Department of Dental Research and Implantology
Room number 104
Brig S K Mazumdar Marg
Timarpur
North West
DELHI |
01123942255
amitbhandari1093@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K050||Acute gingivitis. Ayurveda Condition: DANTAVAIDARBAH/DANTAVIDARBA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Chlorhexidine | Is considered the gold standard for maintaining oral hygiene. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: INMAS G-10, Reference: Ayurveda, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 200(mg), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: INMAS G-10, Reference: Ayurveda, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 200(mg), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients more than 18 years of age.
2. Patients with presence at least 22 teeth.
3. Patients with moderate to severe gingivitis.
|
|
| ExclusionCriteria |
| Details |
•Patients not willing to be a part of the study.
•Patients with known allergy to any component of the oral rinse.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in plaque, gingival inflammation and gingival bleeding |
Baseline, 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Halitosis |
0 day, 3 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/09/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The effectiveness of new Ayurvedic oral hygiene formulation in controlling plaque, gingival inflammation and bleeding will be compared with chlorhexidine, a gold standard agent. |