| CTRI Number |
CTRI/2018/04/013038 [Registered on: 04/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study the efficacy of toothpastes in teeth sensitivity |
|
Scientific Title of Study
|
A Clinical trial to evaluate the efficacy and comparison of a dentifrice containing Sodium Fluoride; 8% Strontium Acetate, Strontium Acetate (in Herbal Base) and two different Herbal dentifrices in reducing Dentinal Hypersensitivity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPDC/IEC/24/PHD/2013, 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 and Hospital |
OPD,Department of Public Health Dentistry, Inderprastha Dental College & Hospital Inderprastha Dental College and Hospital,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: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Toothpaste A |
Active ingredients: Strontium acetate, Sodium Fluoride
The product was applied with the toothbrush twice daily for 60 seconds for 6 weeks. |
| Intervention |
Toothpaste B |
Active ingredients: Strontium acetate, Gairic powder, Herbal extract (Anacyclus pyrethrum, Piper nigrum, Piper longum, Zingiber officinale, Zanthoxylum armatum)
The product was applied with the toothbrush twice daily for 60 seconds for 6 weeks. |
| Intervention |
Toothpaste C |
Active ingredients:Herbal extract (Anacyclus pyrethrum, Piper nigrum, Piper longum, Zingiber officinale, Zanthoxylum armatum), Gairic powder
The product was applied with the toothbrush twice daily for 60 seconds for 6 weeks. |
| Intervention |
Toothpaste D |
Active ingredients: Herbal extract (Piper nigrum, Piper longum, Zingiber officinale, Zanthoxylum armatum), Gairic powder
The product was applied with the toothbrush twice daily for 60 seconds for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with dental hypersensitivity complaints |
|
| ExclusionCriteria |
| Details |
1. Subjects who had dental pathology causing pain similar to cervical dentinal hypersensitivity (such as teeth with caries, the presence of orthodontic appliances and restorations and/or the presence of a history of periodontal surgery in the area of the tooth during the previous three months)
2. Subjects who had taken any medication
3. Subjects who received professional treatment with desensitizing agents in the previous six months
4. Subjects who received any treatment in the past 3 months
5. Subjects who were pregnant or lactating
6. Subjects who had any systemic diseases and/or the presence of a vital bleaching history |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of dentin hypersensitivity immediately after a single self-application, as well as after a subsequent twice daily brushing for a period of 6 weeks |
Baseline, 60 seconds, 3 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "139"
Final Enrollment numbers achieved (India)="139" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2013 |
| Date of Study Completion (India) |
15/10/2013 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="16" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Sonia datta,Pankaj datta. A Clinical trial to evaluate efficacy of a dentifrice containing sodium fluoride & 8% strontium acetate, Strontium acetate (in herbal base) and two herbal dentifrices in reducing dentinal hypersensitivity. Indian Journal of Dental Education,Volume 8 Number 2, April-June 2015. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study was randomized, monocentric, parallel group, open label, four arm trial efficacy study. The duration of treatment was conducted for a period of 6 weeks on subjects and included a total of 4 visits (Baseline, 60 seconds, 3 weeks and 6 weeks). The subjects who satisfy inclusion/exclusion criteria were enrolled after obtaining informed consent. A total of 140 subjects were randomly divided into four experimental groups and ages between 20-60 years (both the ages inclusive) were enrolled in the study. A total of 139 subjects completed the six weeks study period. There was no side effects/ adverse event during the period of the study. The dentin sensitivity assessment was done using the tactile and air blast (Schiff’s Scale) hypersensitivity method. Instant and lasting relief from dentin hypersensitivity was reported at the end of 6 week study period with test toothpaste A and B but not with toothpaste C and D. |