| CTRI Number |
CTRI/2022/09/046004 [Registered on: 28/09/2022] Trial Registered Prospectively |
| Last Modified On: |
07/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
A comparative clinical study to evaluate the efficacy of Ayurvedic Dentifrices in providing dental protection
|
Scientific Title of Study
Modification(s)
|
A comparative clinical study to evaluate the efficacy of Ayurvedic Dentifrices in providing dental protection
|
| Trial Acronym |
NA |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| ORAL/DADM/2022-04; version 2.0; Date 28 October 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmi Chandrasekaran |
| Designation |
Principal Investigator - MDS |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15, 1st Main Road, Cambridge layout Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
lakshmi@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sasibhushan Vedula |
| Designation |
Head - Medical Affairs and Clinical Research |
| Affiliation |
Dabur Research and Development Centre |
| Address |
Plot No.22, Site IV, Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01204378405 |
| Fax |
01204552645 |
| Email |
sasibhushan.vedula@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Ritambhara |
| Designation |
Director |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15, 1st Main Road, Cambridge layout Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
918040917253 |
| Fax |
918041125934 |
| Email |
ritambhara@mscr.in |
|
|
Source of Monetary or Material Support
|
| Dabur Research and Development Centre
Dabur India Limited
Plot No.22, Site IV,
Sahibabad-201010,
Ghaziabad (U.P.),
India |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
8/3, Asaf Ali Road, New Delhi, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Lakshmi Chandrasekaran MDS |
MS Clinical Research Pvt. Ltd |
327/15, 1st Main Road
Cambridge layout, Ulsoor
Bangalore
KARNATAKA |
918040917253
918041125934
lakshmi@mscr.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K088||Other specified disorders of teethand supporting structures. Ayurveda Condition: DANTAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Marketed White Toothpaste | (1) Medicine Name: Marketed White Toothpaste, Route: Oral, Dosage Form: Toothpaste, Dose: 2-3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 days, anupAna/sahapAna: No | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ayurvedic Dentifrice Tooth Paste, Reference: NA, Route: Oral, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Approx. 2-3 g of Ayurvedic Dentifrice Tooth Paste | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ayurvedic Dentifrice Herbal Tooth Powder, Reference: NA, Route: Oral, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: approx. 1-1.5g of Ayurvedic Dentifrice Herbal Tooth Powder | | 4 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ayurvedic Dentifrice sprinkled over marketed white toothpaste, Reference: NA, Route: Oral, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 50(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Ayurvedic Dentifrice (approx. 50 mg) will be sprinkled over Marketed white tooth Paste (2-3 g) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female subjects in age group 18 – 55 years (both the ages inclusive).
2.Having at least 16 natural, permanent teeth.
3.Subjects with poor dental hygiene (self-reported and clinically diagnosed)
4.Subjects who have plaque and dental caries. (Caries score up to 2 using International Caries Detection and Assessment System (ICDAS).
5.Subjects with extrinsic dental stains (Score up to 2 using Lobene Stain Index)
6.Subjects willing to give their oral swab samples for analysis.
7.Subjects willing to come for follow up visits at the specified time.
8.Subjects ready to follow study related procedures during the study period.
9.Subject able to read, understand and sign an appropriate informed consent form indicating willingness to participate.
|
|
| ExclusionCriteria |
| Details |
1.A known history or present condition of hypersensitivity to any toothpaste and tooth powder
2.Subjects taking any supplementation known to support teeth health which may interfere study results.
3.The use of antibiotic, analgesic medications, mouthwash or desensitizing toothpaste during the previous 1 month.
4.Any history of periodontal therapy by surgical interventions.
5.Subjects with active periodontal conditions.
6.Subjects who have used any medicated/fluoridated toothpastes.
7.Orthodontic treatment with fixed appliances.
8.Any removable device such as a removable partial denture or orthodontic retainer.
9.The presence of any fixed appliance, large or defective restorations, cracked enamel,
10.Subjects who have a history of smoking or use smokeless tobacco products/betel chewing
11.Subjects who are pregnant or lactating
12.Subjects having severe level of calculus and/ tartar.
13.Any underlying systemic illnesses, medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, a positive HIV status, hepatitis etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in teeth health basis dental examination (Teeth surface, Plaque and Caries) with regular use of study product in comparison to the baseline and with White toothpaste
2. Improvement in gum health (colour, consistency, gum bleeding) as per the dental examination (Gingiva) with regular use of study product in comparison to the baseline and with White toothpaste |
Day 1 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Reduction in teeth stains
•Reduction in malodour causing bacteria
•Improvement in teeth colour
•Reduction in Plaque Index.
•Reduction in halitosis basis VSC (Volatile Sulphur Compounds) scores (Oral chroma)
•Reduction in gingival index
•Change in Teeth colour using Vita Shade Guide assessment and Image analysis.
•Reduction in Lobene stain index
-Demineralization of teeth using Imaging in
comparison to the baseline and with comparator product (exploratory) |
Day 1 and day 30 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="140"
Sample Size from India="140"
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)
Modification(s)
|
16/11/2022 |
| 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="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This will a comparative study to evaluate the effect of Ayurvedic Dentifrices in providing dental protection in comparison to the baseline and/or white toothpaste. There will be four arms in the study. A total of 140 subjects (35 in each group to get minimum 30 completers ) will be enrolled. Study intervention period will be of one month. Results will be analyzed using suitable statistical methods. |