| CTRI Number |
CTRI/2024/05/066921 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study for the comparison and evaluation of the role of three different agents in the treatment of dentinal hypersensitivity of teeth among the affected patients. |
|
Scientific Title of Study
|
A comparative clinical evaluation of the efficacy of three desensitizing agents for the treatment of dentinal hypersensitivity. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Chaudhuri |
| Designation |
MDS Post graduate trainee, Department of Conservative dentistry and Endodontics |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Guru Nanak Institute of Dental Sciences and Research
157/F Nilgunj Road Panihati Sodepur Kolkata.
Department of Conservative dentistry and Endodontics, Room number 2 , Second floor.
157/F Nilgunj Road Panihati Sodepur Kolkata.
Department of Conservative dentistry and Endodontics, Room number 2 , Second floor.
Kolkata
WEST BENGAL
700114
India |
| Phone |
08170934857 |
| Fax |
|
| Email |
ankita.chaudhuri1109@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ipsita Maity |
| Designation |
Professor , Department of Conservative Dentistry and Endodontics |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Guru Nanak Institute of Dental Science and Research.
157/F Nilgunj Road Panihati Sodepur Kolkata.
Department of Conservative dentistry and Endodontics.
Room number 2 , 2nd floor.
157/F Nilgunj Road Panihati Sodepur Kolkata.
Department of Conservative dentistry and Endodontics.
Room number 2 , 2nd floor.
Kolkata
WEST BENGAL
700114
India |
| Phone |
9051860156 |
| Fax |
|
| Email |
ipsita.maity@gnidsr.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Chaudhuri |
| Designation |
MDS Post graduate trainee |
| Affiliation |
Guru Nanak Institute of Dental Sciences and Research |
| Address |
Guru Nanak Institute of Dental Science and Research.
157/F Nilgunj Road Panihati Sodepur Kolkata
Department of Conservative dentistry and Endodontics, Room number 2 , 2nd floor.
157/F Nilgunj Road Panihati Sodepur Kolkata
Department of Conservative dentistry and Endodontics, Room number 2 , 2nd floor.
Kolkata
WEST BENGAL
700114
India |
| Phone |
08170934857 |
| Fax |
|
| Email |
ankita.chaudhuri1109@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Institute of Dental Science and Research.
157/F Nilgunj Road Panihati Sodepur Kolkata.
Department of Conservative dentistry and Endodontics |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Institute of Dental Science and Researchri |
| Address |
157/F Nilgunj Road Panihati Sodepur Kolkata - 700114 , West Bengal , India.
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Ankita Chaudhuri |
Guru Nanak Institute of Dental Sciences and Research |
157/F Nilgunj Road Panihati Sodepur Kolkata.
Department of Conservative dentistry and Endodontics , 2nd floor , Room number 2.
Kolkata
WEST BENGAL |
8170934857
ankita.chaudhuri1109@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Reporting to the outpatient department with only the chief complaint of dentinal hypersensitivity. |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Desensitizing agents |
Comparison between three agents for the treatment of dentinal hypersensitivity. |
| Intervention |
Desensitizing agents for the treatment of dentinal hypersensitivity |
Three types of desensitizing agents to be used
1. Diode laser therapy
2. MI varnish therapy
3. Gluma desensitizer therapy
on teeth affected by dentinal hypersensitivity for a period of 1 month. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patients with the chief complaint of dentinal hypersensitivity affecting a minimum of single tooth in the oral cavity.
2. Presence of gingival recession , attrition , abrasion , abfraction lesion.
3. No radiographic evidence of periapical lesions associated with the tooth. |
|
| ExclusionCriteria |
| Details |
1. Patients who have undergone professional desensitizing treatment or used desensitizing toothpaste for the last 3 months.
2.Presence of periodontal disease or undergoing treatment for the same.
3.Tooth affected by caries or irreversible pulpitis.
4. Tooth with cervical restoration or presence of full coverage crown .
5. Medically compromised patients.
6. Pregnant or lactating women. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy of the three different desensitizing agents for the treatment of dentinal hypersensitivity . |
Immediate post-operatively , after 7 days , after 14 days , after 1 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparative evaluation of the clinical efficacy of the three different desensitizing agents in the management of dentinal hypersensitivity |
Immediate post-operatively , after 7 days , after 14 days , after 1 month |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| Date of Study Completion (India) |
30/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/06/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Dentinal hypersensitivity is a condition commonly encountered in dental practise , particularly in individuals suffering from abrasion , gingival recession , tooth erosion which leads to patient discomfort hampering daily activities. It can be treated by various in-office treatment options or by application of desensitizing agents by the patient at home. However, there is a great variation in the types of treatment available , with insufficient data concerning the relative effectivenes of these treatments. So the aim of the study is to comparitively evaluate the clinical efficacy of three different desensitizing agents in treatinf dentinal hypersensitivity which includes the Diode laser , GC Mi varnish and Gluma desensitizer. Sensitivity of the tooth will be assessed using tactile and evaporative stimuli before initiating any treatment and immediately after treatment using a 10 point visual analogue scale to determine the change in pain sensation. Patient will be recalled at resular intervals of 7 days , 14 days and 1 month to assess the change in pain response. Statistical analysis will be performed after all the data are collected to obtain the results, |