| CTRI Number |
CTRI/2026/02/103429 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Different Ways to Treat Sensitive Teeth |
|
Scientific Title of Study
|
Comparitive Evaluation of Efficacy of Diode Lasers,Fluoride and Desensitizing agent on Hypersensitivity- A Randomized Clinical Trial. |
| Trial Acronym |
Sensitive Teeth Evaluation Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sathish Abraham |
| Designation |
Professor and HOD |
| Affiliation |
SMBT Dental College and Hospital Amrutnagar Sangamner |
| Address |
Department of Conservative Dentistry and Endodontics Room No 101 SMBT Dental College and Hospital,Amrutnagar,Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
7798686067 |
| Fax |
|
| Email |
abrahamsats@mail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sathish Abraham |
| Designation |
Professor and HOD |
| Affiliation |
SMBT Dental College and Hospital Amrutnagar Sangamner |
| Address |
Department of Conservative Dentistry and Endodontics Room No 101 SMBT Dental College and Hospital,Amrutnagar,Ghulewadi, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
7798686067 |
| Fax |
|
| Email |
abrahamsats@mail.com |
|
Details of Contact Person
Public Query
|
| Name |
Om Divekar |
| Designation |
Undergraduate Student |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
SMBT Dental College and Hospital Amrutnagar Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
8208530548 |
| Fax |
|
| Email |
divekarom0548@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental College and Hospital,Sangamner-422608 Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
SMBT Dental College and Hospital |
| Address |
Amrutnagar,Ghulewadi,Sangamner-422608 |
| Type of Sponsor |
Other [Private Dental College and Hospital] |
|
|
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 |
| Om Divekar |
SMBT Dental College and Hospital,Sangamner |
101,Department of Conservative dentistry and Endodontics, Sangamner-422608,Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
8208530548
divekarom0548@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee on Ethics ,SMBT Dental College,Sangamner |
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, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1-5% Sodium Fluoride Varnish (drug/chemical comparator)
2-Desensitizing Agent- Gluma |
b Fluoride group:
The tooth will be dried and isolated like first group to prevent the varnish from mixing with saliva. Two thin layers of sodium fluoride varnish 5% would be rubbed on the tooth surface with a disposable micro-brush according to the factory’s instructions. Patients would be instructed to refuse from eating any carbonated foods or beverages for 1 h after the varnish application. The cotton roll will be removed to allow moisture to set the varnish.
c) Desensitizing agent group:
After drying tooth surface and isolation with cotton roll same as other groups, the Gluma would be applied with rubbing motion gently but firm. After 30 to 60 s, the dentine will be completely dried until the liquid will disappear and the surface entirely loses its gloss. Aiming beam would be applied to the tooth sur face for 30 s.
|
| Intervention |
Diode Laser (Device Intervention) |
This randomized in vivo clinical trials study will be performed on 30 individuals with dentin hypersensitivity due to gingival recession randomly distributed across three groups:
ten individuals who were treated with diode laser, ten who were treated with fluoride,
and ten treated with dentin bonding agent.
This study will be conducted between 3 - 4 months. The distribution of participants among groups will be performed randomly with a sealed envelope, in which numbers corresponding to the treatment modalities will be placed.
All patients would be advised to avoid brushing with excessive force and excess consumption of sour or acidic food. Prior of treatment, the degree of tooth
sensitivity to evaporative stimuli will be evaluated by an air syringe flow. The
tooth will be dried and isolated, and a stream of cold air will be inserted into the buccal surface of the tooth for 35 s from a distance of 2 mm, and the tooth’s response to this stimulus will be recorded via visual analog scale (VAS). The VAS score is a score that patient gives in response to a painful stimulus. The
lowest score would be zero which would mean a completely pain less situation, and the
highest score would be 10 which would mean the most painful thing that a human can experience. Any number reported by the patient would be considered degree of sensitivity. After recording the tooth initial sensitivity, according to the group that wwill be randomly assigned, the tooth will receive one of the following treatment protocols:
a) Diode laser group:
The tooth will be dried with air-syringe flow and isolated with a cotton roll. Diode laser will be applied perpendicular to the buccal surface in S mode by scanning movement defocusing at distance of 1 mm with water (0%) and air (0%) for 30 s.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
45.00 Day(s) |
| Gender |
Both |
| Details |
1. Good general health without any known allergy to the products which are being used in the hypersensitive Treatment.
2. The teeth will be free of decay or restoration.
3. Patients have not previously received any dentine hyper- sensitivity treatments.
4. Patients have no history of receiving any teeth whitening treatments.
5. The degree of tooth initial sensitivity should be 3 or higher based on VAS.
6. Patient should agree to sign consent form.
|
|
| ExclusionCriteria |
| Details |
1. Patients with chronic diseases and daily pain episodes who would have taken anticonvulsants, analgesics, antihistamines, sedatives, anti-inflammatories, or painkillers in the past 72 h.
2. Patients who would have used desensitizing toothpaste or mouthwash in the last 3 months.
3. Patients who would have had periodontal surgery in the last 6 months.
4. Vital or non-vital teeth that would have cracks, previous resto- ration, carious lesions, gingival recession of more than 3 mm or active periodontal disease.
5. Teeth with deep carious lesions in the vicinity of sensitive teeth that their pain can be confused with tooth sensitivity.
6. Patients whose sensitive teeth would be adjacent together. Patients will be informed about the aim of study and its design, and informed consent will be obtained.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in dentin hypersensitivity response after using diode laser fluoride and desensitizing agent |
Data collected prior to treatment protocols.
Base line data collected immediately after treatment protocols, after one month and three months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of Mean VAS Scores between pairs:
1. Diode Laser vs. Fluoride
2. Diode Laser vs. Gluma
3. Fluoride vs. Gluma |
Baseline (Day 0), after one month and after 3 months. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/05/2026 |
| 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="0"
Months="4"
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 randomized clinical trial evaluates and compares the efficacy of three treatment modalities—Diode lasers, 5% Sodium Fluoride varnish and a Desensitizing Agent (Gluma)—on dentin hypersensitivity. 30 participants with a Visual Analog Scale (VAS) sensitivity score of 3 or higher are randomly assigned to one of three groups (10 per group). Sensitivity is measured using a 35-second cold air stimulus from a 2 mm distance. The study aims to determine if there is a significant difference in pain reduction between these methods over a period of 3 to 4 months. |