| CTRI Number |
CTRI/2025/12/098297 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Herbal Tooth Powder on Oral Hygiene |
|
Scientific Title of Study
|
Efficacy Of Musta Amalaki Twak Churna In Dantadhavana For Maintainance Of Oral Hygiene A Randomised Controlled Clinical 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 |
Gat Namrata Ramesh |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belgavi |
| Address |
Department of Swasthavritta and Yoga OPD NO 2 KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya shahapur Belgavi
Belgaum
KARNATAKA
590003
India |
| Phone |
7385131541 |
| Fax |
|
| Email |
namratagat13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep S Sagare |
| Designation |
Professor and Head of Department |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belgavi |
| Address |
Department of Swasthavritta and Yoga OPD NO 2 KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya shahapur Belgavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9844586894 |
| Fax |
|
| Email |
sandeepsagare.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep S Sagare |
| Designation |
Professor and Head of Department |
| Affiliation |
KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belgavi |
| Address |
Department of Swasthavritta and Yoga OPD NO 2 KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya shahapur Belgavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9844586894 |
| Fax |
|
| Email |
sandeepsagare.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Shri B M Kankanwadi Ayurveda Mahavidyalaya shahapur Belgavi karnataka India Pincode 590003 |
|
|
Primary Sponsor
|
| Name |
Gat Namrata Ramesh |
| Address |
Department of Swasthavritta and Yoga OPD NO 2 Kaher Shri B M Kankanwadi Ayurveda Mahavidyalaya shahapur Belgavi |
| 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 Gat Namrata Ramesh |
Kaher Shri B M Kankanwadi Ayurveda Mahavidyalaya |
Department of Swasthavritta and Yoga OPD NO 2 Kaher Shri B M Kankanwadi Ayurveda Mahavidyalaya shahapur Belgavi Karnataka India 590003
Belgaum
KARNATAKA |
7385131541
namratagat13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Shahapur Belgavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects in the age group of 18 to 45 years of either gender With Minimum set of 28 natural teeth
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Musta Amalaki Twak, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: The dosage of churna is in a Quantity sufficient | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: UDM Tooth Powder, Reference: NA, Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: The dosage of churna is in a Quantity sufficient |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Minimum set of 28 natural teeth |
|
| ExclusionCriteria |
| Details |
1 Patients having any systemic diseases like Diabetes mellitus Hypertension Haematological disorders which cause gingivitis
2 Use of Tobacco and alcohol and smoking
3 Orthodontic appliances or dentures or implants
4 Recent professional dental cleaning within 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in
1 Plaque index
2 gingival index
3 Oral Hygiene Index |
Baseline
Day 15
Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Aruchi Scale |
Baseline
Day 15
Day 30 |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="1"
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
|
Maintaining oral hygiene, specifically by comparing its effects on gingival and plaque indices with those of a standard tooth powder.Plaque is a prevalent factor behind numerous oral health issues, such as gingivitis, periodontitis, dental caries, and halitosis. These conditions significantly contribute to oral diseases that present considerable health challenges globally. In India, gingival inflammation related to plaque is common but frequently underrated as a public health concern.
A cross-sectional study conducted on Indian adults with an average age of 31 found a clear connection between plaque build-up and gum inflammation. The research recorded a moderate level of plaque with a Plaque Index of 2.47 ± 0.55 and a Gingival Index of 1.19 ± 0.31. Importantly, over half of the participants brushed their teeth only once a day, which raises the risk of developing advanced periodontal issues.Regular twice-daily brushing along with consistent flossing effectively diminishes plaque accumulation. Nonetheless, more than 50% of adults still experience gingivitis, impacting an average of three to four teeth. This issue has prompted the creation of various chemical dentifrice formulations designed to prevent plaque and gum inflammation. Some of these chemical components, however, may lead to side effects such as tooth discoloration, altered taste, and enamel wear, emphasizing the necessity of carefully selecting oral care products to strike a balance between health and appearance.
Recently, there has been an increasing interest in herbal oral care products, particularly in dentistry, where natural remedies with antiseptic properties are highly regarded. Numerous herbs utilised in India exhibit potential in managing plaque, offering a safer and more economical alternative for enhancing oral hygiene. This study aims to assess the efficacy of Musta Amalaki Twak churna for its potential in maintaining oral hygiene, specifically by comparing its effects on gingival and plaque indices with those of a standard tooth powder |