| CTRI Number |
CTRI/2023/08/056061 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of different toothpastes to control sensitivity of teeth |
|
Scientific Title of Study
|
Comparative evaluation of different desensitizing dentifrices:A randomised control clinical trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshika Sharma |
| Designation |
MDS student |
| Affiliation |
Inderprastha Dental College and Hospital,Sahibabad |
| Address |
Department of Conservative Dentistry And Endodontics ,FF-1 ,Inderprastha Dental College and Hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9354941405 |
| Fax |
|
| Email |
lakshikasharma199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dakshita Joy Sinha |
| Designation |
HOD Department of Conservative Dentistry and Endodontics,Inderprastha Dental College, Sahibabad |
| Affiliation |
Inderprastha Dental College and Hospital,Sahibabad |
| Address |
Department of Conservative Dentistry And Endodontics ,FF-1 ,Inderprastha Dental College and Hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9760340728 |
| Fax |
|
| Email |
dvaghela52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dakshita Joy Sinha |
| Designation |
HOD Department of Conservative Dentistry and Endodontics,Inderprastha Dental College, Sahibabad |
| Affiliation |
Inderprastha Dental College and Hospital,Sahibabad |
| Address |
Department of Conservative Dentistry And Endodontics ,FF-1 ,Inderprastha Dental College and Hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
UTTAR PRADESH
201010
India |
| Phone |
9760340728 |
| Fax |
|
| Email |
dvaghela52@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lakshika Sharma(SELF)
Department of Conservative Dentisty and Endodontics , SF-1 Inderprastha Dental College and Hospital, Sahibabad , Ghaziabad,Uttarpradesh , 201010 |
|
|
Primary Sponsor
|
| Name |
Lakshika Sharma |
| Address |
Department of Conservative Dentistry And Endodontics ,FF-1 ,Inderprastha Dental College and Hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010 |
| Type of Sponsor |
Other [NIL] |
|
|
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 Lakshika Sharma |
Inderprastha Dental College & Hospital |
Department of Conservative Dentistry And Endodontics ,FF-1 ,Inderprastha Dental College and Hospital, 46/1, Sahibabad Industrial Area Site 4, Sahibabad, Ghaziabad, Uttar Pradesh 201010
Ghaziabad
UTTAR PRADESH |
9354941405
lakshikasharma199@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of Inderprastha Dental College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dentin hypersensitivity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Calcium sodium phosphosilicate toothpaste (CSPS)
2.Fluoro calcium phosphosilicate toothpaste(FCPS)
3.Potassium nitrate toothpaste
4.Potassium nitrate with fluoride toothpaste
5.Sodium Fluoride toothpaste
|
1.Calcium sodium phosphosilicate toothpaste (CSPS)
2.Fluoro calcium phosphosilicate toothpaste(FCPS)
3.Potassium nitrate toothpaste
4.Potassium nitrate with fluoride toothpaste
5.Sodium Fluoride toothpaste
topical application at interim efficacy interval of 7th day, 15th day , 28th day , 60th day and 90th day. Total duration of the intervention is 3 months |
| Comparator Agent |
sodium fluoride |
sodium fluoride topical application interim efficacy interval of 7th day, 15th day , 28th day , 60th day and 90th day. Total duration of the intervention is 3 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with age range 20-45 years
2.Participants with self-reported sensitivity in teeth
3.Patients with good general and oral health
4.Patients without known allergy to any commercial dental product
5.Patients with permanent teeth (buccal /facial aspects)
6.Patients responding to cold blast stimulus on SCASS with score >2
7.Patients responding to air blast stimulus and tactile stimulus on VAS with score >4
|
|
| ExclusionCriteria |
| Details |
1.Patients with periodontal disease requiring aggressive treatment
2.Lactating and pregnant women
3.Medically compromised patients
4.Patients with neuromuscular disabilities
5.Teeth with crown or bridges
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of dentifrices containing calcium sodium phosphosilicate (CSPS) in the treatment of dentin hypersensitivity.
To evaluate the effectiveness of dentifrices containing fluoro calcium phosphosilicate (FCPS) in the treatment of dentin hypersensitivity.
To evaluate the effectiveness of dentifrices containing potassium nitrate in the treatment of dentin hypersensitivity.
To evaluate the effectiveness of dentifrices containing potassium nitrate with fluoride in the treatment of dentin hypersensitivity.
To compare the effectiveness of fluoride containing & non fluoride containing anti dental hypersensitivity dentifrices with commonly used dentifrice by measuring pre & post operative dentin hypersensitivity using VAS and SCHIFF Scale.
|
7th day, 15th day , 28th day , 60th day & 90th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of dentifrices containing calcium sodium phosphosilicate (CSPS) in the treatment of dentin hypersensitivity.
To evaluate the effectiveness of dentifrices containing fluoro calcium phosphosilicate (FCPS) in the treatment of dentin hypersensitivity.
To evaluate the effectiveness of dentifrices containing potassium nitrate in the treatment of dentin hypersensitivity.
To evaluate the effectiveness of dentifrices containing potassium nitrate with fluoride in the treatment of dentin hypersensitivity.
To compare the effectiveness of fluoride containing & non fluoride containing anti dental hypersensitivity dentifrices with commonly used dentifrice by measuring pre & post operative dentin hypersensitivity using VAS & SCHIFF Scale.
|
7th day, 15th day , 28th day , 60th day & 90th day
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/08/2023 |
| 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="11"
Days="29" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [lakshikasharma199@gmail.com].
- For how long will this data be available start date provided 15-12-2025 and end date provided 15-12-2055?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This study is a randomized,single blinded, controlled clinical trial comparing different desensitizing dentifrices on 150 patients with dentin hypersensitivity that will be conducted in Sahibabad, Uttar Pradesh. |