| CTRI Number |
CTRI/2018/05/014132 [Registered on: 25/05/2018] 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 |
Single Arm Study |
|
Public Title of Study
|
To study efficacy of toothpastes in providing relief from teeth sensitivity |
|
Scientific Title of Study
|
Clinical Efficacy in reducing dentinal hypersensitivity of a dentifrice containing 5% potassium nitrate in providing instant and lasting relief |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IPDC/IEC/65/PHD/2015, Version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonia Datta |
| Designation |
Assistant Professor |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
Inderprastha Dental College & Hospital, Department of Public health dentistry, Third Floor, Room No. 3, 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 |
Assistant Professor |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
Inderprastha Dental College & Hospital, Department of Public health dentistry, Third Floor, Room No. 3, 46-1 Site IV Industrial Area Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01204176700 |
| Fax |
|
| Email |
pankajdatta97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonia Datta |
| Designation |
Assistant Professor |
| Affiliation |
Inderprastha Dental College & Hospital |
| Address |
Inderprastha Dental College & Hospital, Department of Public health dentistry, Third Floor, Room No. 3, 46-1 Site IV Industrial Area Sahibabad
Ghaziabad
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 |
OPD, 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: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Toothpaste-1 |
Sorbitol, Silica, Aqua, Potassium Nitrate,PEG 32, Sodium lauryl sulphate, Aroma, Glycerin, Cellulose Gum, Benzyl alcohol, Tetrasodium pyrophosphate, Titanium dioxide, Sodium benzoate, Sodium fluoride, Sodium saccharin, Trisodium phosphate, Sodium hydroxide
The product was applied(approximately 2 g) 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)
2.Subjects with 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) 3.Subjects who had taken any medication, subjects who received professional treatment with desensitizing agents in the previous six months, subjects who received any treatment in the past 30 days
4.Subjects who were pregnant or lactating 5.Subjects who had any systemic diseases and/or the presence of a vital bleaching history. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The test product provides instant relief and long lasting relief |
Baseline, 60 seconds, 3 weeks, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall safety of the Subjects throughout the study period |
Baseline, 60 seconds, 3 weeks, 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2015 |
| Date of Study Completion (India) |
31/08/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="16" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Results of this study may be used for publishing scientific papers and data. All the data generated on the study is exclusive property of sponsor and no publication can be done without sponsors written approval |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study was open label, monocentric, single arm trial efficacy study. The purpose of the study was to check the efficacy of a test dentifrice containing 5% potassium nitrate in reducing dentinal hypersensitivity. 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 30 subjects ages between 20-60 years (both the ages inclusive) were enrolled in the study. All the subjects completed the study and no drop outs occurred. There was no side effects/ adverse event during the period of the study. Results: The test product was found to exhibit instant relief after a single direct topical application and lasting dentinal hypersensitivity relief over a period of 6 weeks twice daily application. Sensitivity was assessed by means of tactile and evaporative stimuli. |