| CTRI Number |
CTRI/2026/04/107306 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Laser Treatment With and Without Calcium-Based Varnish for Reducing Tooth Sensitivity: A Clinical Study |
|
Scientific Title of Study
|
Efficacy of Diode Laser with Calcium Phosphate - Based Varnish and Diode Laser alone among patients with dentine hypersensitivity: A Randomized Controlled 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 |
DrHarsha v |
| Designation |
Post Graduate resident |
| Affiliation |
Govt.Dental college Thiruvananthapuram |
| Address |
Deptment of Conservative Dentistry and Endodontics
Room No.252
Govt.Dental College
Thiruvananthapuram
Kerala
Deptment of Conservative Dentistry and Endodontics
Room No.252
Govt.Dental College
Thiruvananthapuram
Kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8606920972 |
| Fax |
|
| Email |
harshavas.v00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shiji Dinakaran |
| Designation |
Professor and Head of the Department of Conservative Dentistry and Endodontics |
| Affiliation |
Govt.Dental college Thiruvananthapuram |
| Address |
Deptment of Conservative Dentistry and Endodontics
Room No.252
Govt.Dental College
Thiruvananthapuram
Kerala
Deptment of Conservative Dentistry and Endodontics
Room No.252
Govt.Dental College
Thiruvananthapuram
Kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9895402488 |
| Fax |
|
| Email |
shijidinakaran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Mridula Parameswaran |
| Designation |
Assistanat Professor |
| Affiliation |
Govt.Dental college Thiruvananthapuram |
| Address |
Department of Conservative Dentistry and Endodontics
Room No.252
Govt.Dental College
Thiruvananthapuram
Kerala
Department of Conservative Dentistry and Endodontics
Room No.252
Govt.Dental College
Thiruvananthapuram
Kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8921617649 |
| Fax |
|
| Email |
mridulatdc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deptment of Conservative Dentistry and Endodontics
Room No.252
Govt.Dental College
Thiruvananthapuram
Kerala
|
|
|
Primary Sponsor
|
| Name |
Dr Harsha v |
| Address |
Deptment of Conservative Dentistry and Endodontics
Room no.A252
Govt.Dental College
Thiruvananthapuram
kerala
695011 |
| 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 |
| DrHarsha v |
Govt.Dental college Trivandrum |
Deptment of Conservative Dentistry and Endodontics
Room No.252
Thiruvananthapuram
KERALA |
8606920972
harshavas.v00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Govt. Dental College Thiruvananthapuram |
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 |
Calcium Phosphate Based varnish
|
Composition- 5% sodium fluoride varnish enhanced with calcium-phosphate
1. Active Ingredient
Sodium Fluoride (NaF) – 5%
Delivers 22,600 ppm fluoride ions
2. Calcium–Phosphate System (RECALT® Technology)
Based on CPP-ACP (Casen Phosphopeptide–Amorphous Calcium Phosphate)
Provides bioavailable calcium and phosphate ions.
Total duration of intervention- 2 minutes. Single coat of varnish will be applied on the affected tooth surface for 2 minutes.Procedure will be completed in a single visit, with only one-time application. |
| Comparator Agent |
DenLase 980 nm |
980-nm GaAlAs diode laser in continuous emission mode at 0.5 W power, in non-contact mode |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
(i) Patients of either sex with age greater than or equal to 18 years
(ii) NCCL, with Tooth wear index score (TWI) 2, not requiring restorative treatment
(iii) Preoperative VAS score greater than or equal to 2
(iv) Patients Willing to provide informed consent |
|
| ExclusionCriteria |
| Details |
(1) Teeth with caries, defective restorations, occlusal restorations, chipped teeth
(ii) Deep periodontal pockets, periodontal surgery within 3 months, and patients with orthodontic appliance or bridge work
(iii) Use of desensitizing paste in the last 3 month
(iv) Patient on analgesics
(v) Uncontrolled systemic disease.
(vi) Persons with mental health issues.
(vii) Pregnant or lactating females
(viii) Patients undergone bleaching
(ix) patients with a proven or suspected milk protein allergy allergy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Diode Laser with Calcium Phosphate-Based varnish and Diode Laser alone among patients with dentine hypersensitivity Evaluation of treatment outcome will be based on VAS Score.
|
VAS scores immediately after treatment, 1, 3, 6 months inte |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the reduction in dentine hypersensitivity between male & female participants following treatment. |
Immediately after treatment, 1, 3, 6 months intervals |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
06/06/2026 |
| 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
|
A single-blind randomized controlled trial evaluating the efficacy of diode laser combined with calcium phosphate–based varnish versus diode laser alone in managing dentine hypersensitivity - DH. The study will be conducted at Government Dental College, Thiruvananthapuram, over 18 months, involving 46 participants - 23 per group. Eligible patients aged greater than or egual to18 years with non-carious cervical lesions - Tooth Wear Index score 2 and a VAS score greater than or equal to 2 will be included. Participants will be randomly allocated into two groups: Group A receiving diode laser alone and Group B receiving calcium phosphate–based varnish - MI Varnish followed by diode laser application. Hypersensitivity will be assessed using tactile, air blast, and cold-graded thermal tests, with pain measured through the Visual Analogue Scale immediately after treatment and at 1, 3, and 6 months. Statistical analysis will compare intergroup and intragroup differences. The study aims to determine whether combination therapy offers superior and sustained reduction in dentine hypersensitivity. |