| CTRI Number |
CTRI/2018/04/013171 [Registered on: 11/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [FMCG] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of two herbal toothpastes in oral hygiene |
|
Scientific Title of Study
|
Comparison of Clinical Efficacy of Two Herbal Dentifrices in Control of Plaque, Gingivitis and Gingival Bleeding Index: A Double blind clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPDC/IEC/94/PHD/2016, Version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonia Datta |
| Designation |
Principal Investigator |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
46-1 Site IV Industrial Area Sahibabad
46-1 Site IV Industrial Area Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01204176700 |
| Fax |
|
| Email |
pankajdatta97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Datta |
| Designation |
Principal Investigator |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
46-1 Site IV Industrial Area Sahibabad
46-1 Site IV Industrial Area Sahibabad
UTTAR PRADESH
201010
India |
| Phone |
01204176700 |
| Fax |
|
| Email |
pankajdatta97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia Datta |
| Designation |
Principal Investigator |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
46-1 Site IV Industrial Area Sahibabad
46-1 Site IV Industrial Area Sahibabad
UTTAR PRADESH
201010
India |
| Phone |
01204176700 |
| Fax |
|
| Email |
pankajdatta97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dabur India Limited,Plot Number 22, Site IV, Sahibabad, Ghaziabad, U.P.- 201010 |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Plot Number 22, Site IV, Sahibabad, Ghaziabad, U.P.- 201010 |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Sonia Datta |
Inderprastha Dental College & Hospital |
Department of Public health dentistry, Third Floor, Room No. 3, 46-1 Site IV Industrial Area Sahibabad
Ghaziabad
UTTAR PRADESH |
01204176700
pankajdatta97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Inderprastha Dental College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Toothpaste-1 |
Calcium Carbonate, Sorbitol, Water, Silica, Sodium Lauryl Sulphate, Flavor, Miswak Extract, Cellulose Gum, Carrageenan, Sodium Silicate, PVM/MA Copolymer, Sodium Saccharin, Zinc Gluconate, Sodium Benzoate, Benzyl Alcohol, CI 77891, p-Thymol
The product was applied with toothbrush twice daily for 6 weeks |
| Comparator Agent |
Toothpaste-2 |
Calcium Carbonate, Sorbitol, Water, Silica, Sodium Lauryl Sulphate, Flavor, Miswak Extract, Cellulose Gum, Carrageenan, Sodium Silicate, PVM/MA Copolymer, Sodium Saccharin, Sodium Benzoate, CI 77891, Triclosan.
The product was applied with toothbrush twice daily for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All subjects having at least 20 natural teeth with no probing depths greater than 3 mm and a plaque index score of 2 or more at baseline.
2. Subjects with plaque index score greater than equal to 1.5 according to the Quigley-hein PI scoring procedure and a gingival index score of freater than equal to 1.0
3. Subjects having adequate oral hygiene with no signs of oral neglect, good periodontal health and no greater than 5 periodontal pockets of 5 mm |
|
| ExclusionCriteria |
| Details |
1. Subjects having history of known sensitivity or oral mucosal tissue reaction to toothpaste.
2. Subjects undergoing antibiotic or anti-inflammatory therapy or undergone such therapy in the past 6 months.
3. Subjects participating in any other study or who had participated in a study within one month prior to enrollment
4. Pregnant or lactating women
5. Subjects presented with orthodontic bands; or partial or removable dentures; or received dental prophylaxis anytime during 2 week prior to the first dental examination
6. Subjects having a history of tobacco, alcohol or drug abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of Plaque, Gingivitis and Gingival Bleeding |
Baseline, 3 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall safety of the subjects throughout the study period |
Baseline, 3 weeks, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/06/2016 |
| Date of Study Completion (India) |
09/10/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="27" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Comparison of Clinical Efficacy of Two Herbal Dentifrices in Control
of Plaque induced Gingivitis: A double Blind Clinical Trial. Indian Journal of Dental Education, Volume 10 Number 1, January - March 2017 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study was randomized, parallel group, monocentric, comparative, standard control, double blind, efficacy study. The duration of product application was conducted for a period of 6 weeks on 80 subjects aged between 20-60 years (both inclusive) and included a total of 3 visits (Baseline, 3 weeks, 6 weeks). The subjects who satisfy inclusion/exclusion criteria were enrolled after obtaining informed consent. All the subjects completed the study with no signs of adverse event/side effects during the study period. Both the toothpastes were found to be significantly reducing plaque, gingivitis and gingival bleeding scores at the end of 6 weeks study period twice daily brushing. The difference in decrease in plaque, gingivitis and gingival bleeding sites was statistically non significant between the two test toothpastes after twice-daily brushing for a period of 6 weeks. |