| CTRI Number |
CTRI/2025/11/097835 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study to check if Ayurdent Toothpaste is Safe and helps in maintaining the mouth and teeth clean and healthy. |
|
Scientific Title of Study
|
A Double-Blind, Placebo-Controlled, Two-Arm, Multi-Center, Phase III
Clinical Study to Evaluate the Safety and Efficacy of Ayurdent in
Improving Overall Dental and Oral Hygiene |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CTSRS/2523 Version No. 1.0 Dated 15 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi LM |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
09739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Ayurveda Products Pvt. Ltd.
Flat No. 40, Pocket H, Ground Floor,
Sarita Vihar, New Delhi- 110 076 |
|
|
Primary Sponsor
|
| Name |
Maharishi Ayurveda Products Pvt. Ltd. |
| Address |
Flat No. 40, Pocket H, Ground Floor,
Sarita Vihar, New Delhi- 110 076 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mudasseer Ahamed |
RR Dental Experts |
343/1, First floor, 32 E Cross Road, Jayanagar 4 th T Block,
Sanjay Gandhi Hospital Road,
Bangalore
KARNATAKA |
08088754471
mudasseerahmed@gmail.com |
| Dr Rampalli Viswa Chandra |
SVS Medical College and Hospital |
Room no 5, Dept of Periodontics, First Floor, Yenugonda Mahabubnagar-509002 India.
Mahbubnagar
TELANGANA |
9908183071
viswachandra@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
| SVS medical college 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: MUKHAROGAH, (2) ICD-10 Condition:K036||Deposits [accretions] on teeth. Ayurveda Condition: DANTAMULAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Yes ( subjects will be instructed to brush with given Product twice daily morning and night (post dinner) for 45 days., Ritucarya: No, Acara Rasayana:No, Other:1. Arm A (n=80): Ayurdent Toothpaste
2. Arm B (n=80): Placebo Toothpaste (identical in appearance, taste, and packaging but without active herbal ingredients) All eligible subjects will be instructed to brush twice daily [morning and night (post dinner)] with the assigned product for 45 days., Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Placebo Toothpaste (identical in appearance, taste, and packaging but without
active herbal ingredients) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female, aged 18 to 55 years.
2. Able and willing to provide written informed consent.
3. Subjects with mild to moderate dental hypersensitivity (self-reported or clinically confirmed).
4. Subjects with de ntal plaque (Plaque Inde x greater than equal to 2) at screening.
5. Subjects in generally good health and considered by the Investigator capable of complying with study procedures and scheduled visits.
6. Willingness to refrain from use of any other toothpaste, mouthwash, or oral hygiene products during the study. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women.
2. Subjects with significant oral pathology, including:
- Advanced generalized chronic inflammatory periodontal disease
- Gross oral pathology (e.g., tumors, soft tissue lesions)
- Carious lesions requiring immediate restorative treatment
3. Subjects with orthodontic appliances, or more than one incisor with prosthetic crown/veneer.
4. Subjects with moderate to advanced periodontal disease.
5. History of oral tumors or significant pathology of hard or soft tissues of the oral cavity.
6. Any systemic illness or condition that may interfere with the Investigator’s interpretation of
study outcomes.
7. Participation in another clinical drug/device trial within 3 months prior to recruitment.
8. Known allergy or hypersensitivity to any of the ingredients in the investigational product or
placebo formulation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Salivary pH balance measured at 0 hour and 12 hour, both pre- and post-brushing, to evaluate the maintenance of optimal pH levels throughout the day.
2. Saliva quality parameters, including:
- Salivary calcium levels
- Salivary phosphate levels
- Buffering capacity of unstimulated and stimulated saliva (bicarbonate concentration)
- Salivary amylase
- Salivary lactate dehydrogenase (LDH)
3. Cleansing effect of saliva in fighting germs up to 12 hours, as determined by microbial swab culture. |
Visit 1-Day 0
Visit 2-Day 15 ±3 Days
Visit 3-Day 30 ±3 Days
Telephonic Follow up visit-Day 45 ±3 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Enamel erosion protection, evaluated through dentist visual assessment and enamel erosion score.
2. Reduction in tooth sensitivity and gum discomfort, assessed by Visual Analogue Scale
(VAS).
3. Improvement in teeth whiteness, assessed by dentist visual evaluation from baseline to end of study.
4. Breath freshness (anti-halitosis), evaluated for up to 12 hours using a patient self-reported scale.
5. Relief in toothache (within 24 hours), assessed by Visual Analogue Scale (VAS).
6. Reduction in dental plaque, assessed by Plaque Index (PI).
7. Reduction in gingivitis and gum inflammation, and gum tightening, evaluated using
Modified Gingival Index (MGI).
8. Assess the changes in perceived stress and its correlation with overall dental health during the trial period.
9. Overall dental health, evaluated using Dentist Global Assessment (DGA) questionnaire |
Visit 1-Day 0
Visit 2-Day 15 ±3 Days
Visit 3- Day 30 ±3 Days
Telephonic Follow up visit-Day 45 ±3 Days
|
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
02/12/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Brief Summary of the Study
This is a randomized, double-blind, two-arm, controlled clinical study to evaluate the efficacy and safety of Ayurdent, an Ayurvedic herbal toothpaste, in adults with mild-to-moderate dental complaints. Ayurdent is formulated without SLS, fluoride, triclosan, or artificial additives and contains a blend of herbs such as Triphala, Neem, Salvadora persica, Liquorice, Clove oil, and essential oils. The study will assess the effect of Ayurdent on salivary pH, saliva quality, plaque control, gingival health, tooth sensitivity, enamel protection, breath freshness, and teeth whiteness compared to a placebo/control toothpaste over a defined period. Both participants and investigators will be blinded to the allocation.
Purpose of the Study
The purpose of this study is to generate robust clinical evidence supporting the safety and efficacy of Ayurdent in improving overall oral health, including gum health, plaque reduction, enamel protection, sensitivity relief, and breath freshness, thereby validating its use as a clinically effective Ayurvedic oral care product. |