| CTRI Number |
CTRI/2025/11/097684 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of diode laser treatment on both inner and outer tooth surfaces in single and multiple sittings for reducing tooth sensitivity |
|
Scientific Title of Study
|
Evaluation of diode laser application on both buccal and lingual surfaces in single and multiple sessions in managing dentinal hypersensitivity: A 12-month randomized controlled 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 |
Saanya |
| Designation |
Post Graduate |
| Affiliation |
JCD Dental College, Sirsa |
| Address |
Department of Conservative Dentistry and Endodontics
Sirsa
HARYANA
125055
India |
| Phone |
8901102817 |
| Fax |
|
| Email |
saanyanagpal2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Singla |
| Designation |
Head of the Department |
| Affiliation |
JCD Dental College, Sirsa |
| Address |
Room no 7 Department of Conservative Dentistry and Endodontics
Sirsa
HARYANA
125055
India |
| Phone |
9466671007 |
| Fax |
|
| Email |
singlaendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saanya |
| Designation |
Post Graduate |
| Affiliation |
JCD Dental College, Sirsa |
| Address |
Department of Conservative Dentistry and Endodontics
HARYANA
125055
India |
| Phone |
8901102817 |
| Fax |
|
| Email |
saanyanagpal2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| JCD Dental College, Sirsa, Haryana |
|
|
Primary Sponsor
|
| Name |
Department of Conservative Dentistry and Endodontics |
| Address |
Name - JCD Dental College, Sirsa |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 Saanya |
JCD Dental College,Sirsa |
Department No.7 Department of Conservative Dentistry And Endodontics
Sirsa
HARYANA |
8901102817
saanyanagpal2001@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 |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buccal and Lingual tooth surfaces |
Application of diode laser energy directly to both the buccal and lingual/palatal tooth surfaces in order to desensitize exposed dentinal tubules and reduce dentin hypersensitivity. |
| Comparator Agent |
Buccal tooth surface |
Application of diode laser energy only to the buccal surface of the hypersensitive tooth to achieve dentinal tubule desensitization and reduce dentin hypersensitivity. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving informed consent for the study.
1 Patients aged 18 years or more
2 Patients diagnosed with dentinal hypersensitivity using tactile and evaporative
stimuli, only on buccal surfaces of teeth
3 Patients who were able to understand visual analogue pain scale (VAS)
• Patients who reported minimum score of 3 on VAS score after tactile and
evaporative stimulus
• Good oral hygiene
• Patients in good general health (ASA classification 1 or 2) |
|
| ExclusionCriteria |
| Details |
Patient not willing to give consent.
1 Patients undergoing orthodontic treatment.
2 Pregnant or lactating women.
3 Patients with systemic conditions affecting dentinal hypersensitivity.
4 Patients who have undergone recent treatment for dentinal hypersensitivity within 6
months.
• Patients with teeth showing evidence of irreversible pulpitis or necrosis
• Patients with carious lesions, defective restorations, facets of attrition, premature
contact, cracked enamel, active periodontal disease, use of daily doses of
medications. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Diode laser application on both buccal and lingual
surfaces of teeth in single or multiple sessions in management of DH. |
1 week, 1, 3, 6, and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the effect of Diode laser application on only buccal surfaces of teeth in
single or multiple sessions in management of DH.
2) To compare the effect of Diode laser application on both (buccal and lingual) surfaces
of teeth with diode laser application on only buccal surface in single session.
3) To compare the effect of Diode laser application on both (buccal and lingual) surfaces
of teeth with diode laser application on only buccal surface in multiple sessions. |
1 week, 1, 3, 6, and 12 months |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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 3 |
|
Date of First Enrollment (India)
|
29/11/2025 |
| 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="0"
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
|
Aim: This study will be performed to evaluate the effect of Diode laser application on both buccal
and lingual surfaces of teeth, in single or multiple sessions, in management of dentin
hypersensitivity, over a period of 12 months.
Methods: Evaporative (air blast) and tactile stimuli will be used to evaluate cervical dentin
hypersensitivity, using a visual analogue scale (0 to 10 cm) in all patients. A total of 116
hypersensitive teeth will be randomly divided into 4 groups:
Group 1: Diode laser application in a single session on the buccal surface only.
Group 2: Diode laser application in 3 sessions (every 48 hours) on buccal surface only.
Group 3: Diode laser application in a single session on both buccal and lingual/palatal surfaces.
Group 4: Diode laser application in 3 sessions on both buccal and lingual surfaces of
hypersensitive teeth.
Results and follow up: After completion of treatment for each respective group, DH will be
evaluated immediately after treatment and at follow ups (1 week, 1, 3, 6, and 12 months) using
evaporative and tactile tests. The subject response will be quantified by using a visual analog scale
in which the patient places a mark on a 10 cm line labeled from “no sensitivity (0) to maximum
sensitivity” (10). The obtained data will be analysed using F tests - ANOVA: Fixed effects,
omnibus, one-way in SPSS Version 22 at a significance level of P < .05. |