| CTRI Number |
CTRI/2025/07/090839 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO COMPARE LASER TREATMENTS WITH STANDARD TREATMENTS IN ADULTS FOR SENSITIVE TEETH AND CHECK WHICH ONE IS BETTER |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF DIFFERENT METHODS FOR THE TREATMENT OF DENTIN HYPERSENSITIVITY: A RANDOMIZED 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 |
Dr Bhavana Shikari |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
203 Second Floor Department Of Conservative Dentistry and Endodontics Government Dental College And Hospital Pathikashram Road Navagam Ghed Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9082915331 |
| Fax |
|
| Email |
bhavanashikari1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leena Jobanputra |
| Designation |
Professor and Head of the Department |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
Department of Conservative Dentistry and Endodontics Government Dental College And Hospital Pathikashram Road Navagam Ghed Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9879503545 |
| Fax |
|
| Email |
lihiren@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavana Shikari |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
203 Second Floor Department of Conservative Dentistry and Endodontics Government Dental College And Hospital Pathikashram Road Navagam Ghed Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9082915331 |
| Fax |
|
| Email |
bhavanashikari1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Jamnagar, Pathikashram Road, Navagam Ghed, Jamnagar, Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Dr Bhavana Shikari |
| Address |
203, Second Floor, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Pathikashram Road, Navagam Ghed, Jamnagar, Gujarat 361008 |
| 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 |
| Dr Bhavana Shikari |
Government Dental College and Hospital , Jamnagar |
203, Second Floor,Department of Conservative Dentistry and Endodontics, Jamnagar, Gujarat
Jamnagar
GUJARAT |
9082915331
bhavanashikari1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, M P Shah Medical College and Guru Gobind Singh Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K031||Abrasion of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Power Diode Laser |
After isolation, Irradiation of tooth surface with 980nm high power diode LASER (Biolase epicX)from a distance of 1mm for 30 seconds in continuous mode |
| Comparator Agent |
MI varnish |
After isolation , MI varnish will be applied onto the tooth surface using disposable brush |
| Intervention |
Shield Force Plus Light Cure Desensitizer |
After drying the tooth and isolation, gentle rubbing of Shield force plus light cure desensitizer on tooth surface for 30 seconds followed by air drying for 5 seconds and light curing for 10 seconds will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are 18 to 70 years old with complaints of DHS for more than 1 year
Stimulated DHS more than 6 on the visual analogue scale
DHS that affected 3 nonadjacent teeth of different mouth semiarches
Patients with NCCL or Gingival recession (Miller Class I and II gingival recession)
|
|
| ExclusionCriteria |
| Details |
Patients who have undergone Periodontal surgery in the last 3 months
Use of desensitizing paste or any desensitizing treatment in the last 3 months
Patients undergoing orthodontic treatment
Pregnant or breastfeeding women
Teeth with caries pulpitis congenital anomalies fracture or occlusal interferences |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Dentin Hypersensitivity |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Long term clinical efficacy of desentizing methods |
18 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This study will be a randomized, split-mouth, controlled clinical trial designed to evaluate the efficacy of three different agents in the treatment of dentin hypersensitivity. A total of 90 teeth with dentin hypersensitivity will be included. Each patient’s mouth will be divided into three quadrants, with each receiving one of the two test agents (HIGH-POWER DIODE LASER , RESIN BASED LIGHT CURE DESENSITIZING AGENT). The third quadrant may serve as a positive control with MI VARNISH. Sensitivity levels will be assessed at baseline (T0) using standardized methods such as the Visual Analog Scale (VAS), air-blast test, or tactile test. Follow-up evaluations will be conducted at Immediately (T1),1 week post-treatment(T2) , 3 months post-treatment (T3), and after 6 months(T4) to monitor changes in sensitivity levels and compare the effectiveness of the three agents. This split-mouth design will minimize individual variability and allow for direct intra-patient comparisons of the treatments |