| CTRI Number |
CTRI/2024/04/066352 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of three desensitizing agents in management of dentinal hypersensitivity in adults experiencing pain due to hypersensitivity- an in-vivo study |
|
Scientific Title of Study
|
Comparison of three desensitizing agents in reduction of dentinal hypersensitivity an in vivo study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thanima Chandran |
| Designation |
PG Student |
| Affiliation |
DR.RAJESH RAMDASJI KAMBE DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of Conservative dentistry and Endodontics Dr. Rajesh Ramdasji Kambe dental college and hospital, Akola Kanheri sarap, Akola Department of Conservative dentistry and Endodontics Dr. Rajesh Ramdasji Kambe dental college and hospital, Akola Kanheri sarap, Akola Akola MAHARASHTRA 444001 India |
| Phone |
07559417823 |
| Fax |
|
| Email |
thanima1221@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Thanima Chandran |
| Designation |
PG Student |
| Affiliation |
DR.RAJESH RAMDASJI KAMBE DENTAL COLLEGE |
| Address |
MDS
Department of Conservative dentistry and Endodontics Dr. Rajesh Ramdasji Kambe dental college and hospital, Akola Kanheri sarap, Akola
MDS
Department of Conservative dentistry and Endodontics Dr. Rajesh Ramdasji Kambe dental college and hospital, Akola Kanheri sarap, Akola Akola MAHARASHTRA 444001 India |
| Phone |
07559417823 |
| Fax |
|
| Email |
thanima1221@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR.MANOJ LIKHITKAR |
| Designation |
Head of the Department of Conservative dentistry and Endodontics |
| Affiliation |
DR.RAJESH RAMDASJI KAMBE DENTAL COLLEGE |
| Address |
Department of Conservative dentistry and Endodontics Dr. Rajesh Ramdasji Kambe dental college and hospital, Akola Kanheri sarap, Akola
AKOLA Department of Conservative dentistry and Endodontics Dr. Rajesh Ramdasji Kambe dental college and hospital, Akola Kanheri sarap, Akola Akola MAHARASHTRA 444001 India |
| Phone |
9920666031 |
| Fax |
|
| Email |
manojlikhitkar22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adults exhibibiting dentinal hypersensitivity in atleast three teeth and who falls under the inclusion criteria |
|
|
Primary Sponsor
|
| Name |
Thanima Chandran |
| Address |
Dr. Rajesh Ramdasji Kambe dental college and hospital
Akola
444001 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Thanima Chandran |
Dr. Rajesh Ramdasji Kambe dental college and hospital |
Department of Conservative Dentistry and Endodontics Akola MAHARASHTRA |
7559417823
thanima1221@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Rajesh Ramdasji Kambe dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
comparative clinical evaluation on patients with dentinal hypersensitivty |
three months |
| Comparator Agent |
desensitizing agents (D/Sense Crystal, Fluorprotector vivampuole,Single Bond Universal dentin bonding agent) |
three months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients who had a maximum of two non-adjacent teeth with no cervical caries.
2)Patients with good oral hygiene.
3)Patients with complete general health.
4) Patients who agreed to participate in this 3-month study.
|
|
| ExclusionCriteria |
| Details |
1)Patients who had systemic diseases and/or psychologic disorders, or previous hospitalization and females who are pregnant.
2) Teeth with caries, cracks, or fracture at their cervical margin.
3) Teeth with extensive or faulty restorations, prostheses, or orthodontic appliances.
4) Substance abusers and patients taking analgesics and/or anti-inflammatory drugs.
5)Patients with a history of using desensitizing agents.
6) Patients who had allergy to materials used in the study.
7) Patients who did not consent to participation.
8) Patients who did not attend the follow-up.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| considering thedropout rate of 10 percent the sample size will be 78 and outcome is to comapre and evaluate the efficacy of densitizing agent in reduction of dentinal hypersensitivity. |
IMMEDIATE, 1 WEEK,1 MONTH ,3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to clinically evaluate the reduction of dentinal hypersensitivity and evaluation of prognosis of the treatment |
2 months, 3 months. |
|
|
Target Sample Size
|
Total Sample Size="78" Sample Size from India="78"
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 4 |
|
Date of First Enrollment (India)
|
06/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [thanima1221@gmail.com].
- For how long will this data be available start date provided 04-12-2024 and end date provided 04-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aim: The aim of this in vivo study was to compare the efficacy of three desensitizing agents in reducing dentinal hypersensitivity. The investigation focused on assessing the immediate and lasting effects of the three agents on alleviating discomfort associated with dentinal hypersensitivity. Methods: A randomized controlled trial was conducted on a cohort of patients presenting with dentinal hypersensitivity. In this study, a total of 25 patients with at least three teeth exhibiting dentin hypersensitivity (78 teeth in total) were assessed. Three groups were randomly assigned to receive different treatments for the teeth: Group 1 received D/Sense Crystal treatment, Group 2 received Fluorprotector vivampuole therapy, and Group 3 received Single Bond Universal dentin bonding agent. Using a visual analogue scale (VAS), dentin hypersensitivity levels were measured based on the patients’ reactions to touch, air blast, and cold water stimuli. Before and after treatment, at particular intervals (one, seven, fourteen, sixty, and ninety days), pain levels were noted. Results: Initially, the baseline sensitivity measurements were similar across the three groups (Group-1: 9.2 ± 0.35, Group-2: 8.8 ± 0.46, Group-3: 8.9 ± 0.39) with a non-significant p-value of 0.15. However, significant differences in sensitivity reduction were observed immediately after treatment, with Group-3 exhibiting the most substantial decrease (5.3 ± 0.43) and Group-2 showing a moderate reduction (6.5 ± 0.45) with a p-value of 0.03. Over the 1-week, 1-month, and 3-month follow-ups, although differences persisted, they were not statistically significant (p-values of 0.09, 0.12, and 0.45, respectively). This study underscores the variable impacts of the dental agents on sensitivity reduction, emphasizing the need to consider both short-term and long-term effects when assessing dental treatments. Conclusion: To summarize, this clinical trial successfully showcased a considerable reduction in dentin hypersensitivity (DH) across all three groups, with no reported side effects. After a single direct topical treatment, the Single Bond Universal dentin bonding agent administration resulted in an initial decrease in DH. Notably, at the 3-month follow-up, comparable DH scores were observed among all three groups. |