| CTRI Number |
CTRI/2025/09/095228 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effectiveness of Bioglass based gel and laser treatment on tooth sensitivity |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of a desensitizing agent containing bioglass with diode laser in non carious cervical lesions - 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 |
Chaitali Mahendra Sankpal |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D.Y. Patil dental college and Hospital, Dr. D.Y. Patil Vidhyapeeth |
| Address |
Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune
2D, Department of Conservative Dentistry and Endodontics
Pune
MAHARASHTRA
411018
India |
| Phone |
9869657385 |
| Fax |
|
| Email |
chaitali23pal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srinidhi SR |
| Designation |
Professor |
| Affiliation |
Dr. D.Y. Patil dental college and Hospital, Dr. D.Y. Patil Vidhyapeeth |
| Address |
Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune
2E, Department of Conservative Dentistry and Endodontics
Pune
MAHARASHTRA
411018
India |
| Phone |
9372342232 |
| Fax |
|
| Email |
srinidhi.sr@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Chaitali Mahendra Sankpal |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D.Y. Patil dental college and Hospital, Dr. D.Y. Patil Vidhyapeeth |
| Address |
Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune
2D, Department of Conservative Dentistry and Endodontics
Pune
MAHARASHTRA
411018
India |
| Phone |
9869657385 |
| Fax |
|
| Email |
chaitali23pal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chaitali Mahendra Sankpal |
| Address |
Flat no. 1701, Krishna heritage, Opp. Don Bosco School, link road, Borivali west, Mumbai Maharashtra, India 400 091. |
| 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 |
| Chaitali Mahendra Sankpal |
Dr. D.Y. Patil Dental College and Hospital |
2D, Department of Conservative Dentistry and Endodontics
Pune
MAHARASHTRA |
9869657385
chaitali23pal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y. Patil Dental college and Hospital, Dr. D.Y. Patil Vidhyapeeth |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bio-enamel remineralizing gel, Biolase diode laser |
In the selected cases, bio enamel remineralizing gel will be applied using an applicator brush over the affected area. Diode laser with 940 nm at 1.2W for 1 min, non contact mode. The Schiff sensitivity score will be checked at 0, 1 and 3 weeks. |
| Comparator Agent |
Gluma desensitizer |
In the selected teeth, Gluma will be applied over the affected area with an applicator tip. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with dentinal hypersensitivity on least one tooth in the mouth exhibiting sensitivity to tactile or air stimuli, with a minimum score of 2 of Schiff sensitivity score. Additionally, the affected teeth must exhibit at least one of the following clinical features:
Miller Class I gingival recession
Non-cavitated root surface exposure
Non-carious cervical lesions (NCCLs) caused by abrasion, erosion, abfraction, or any combination of these factors
Initial cavitation (up to 1 mm in depth) that does not require restorative treatment
|
|
| ExclusionCriteria |
| Details |
History of periodontal treatment, use of desensitizing agents or use of any fluoridated toothpaste within the past 3 months.
Teeth with cracks, advanced abrasion/erosion, caries, cavitated lesions needing Class V restorations, fluorosis, or developmental anomalies.
Fractured, endodontically treated teeth, or teeth with extensive restorations.
Presence of orthodontic appliances, removable partial dentures with clasps on affected teeth, or recent dental bleaching.
Parafunctional habits (e.g., bruxism), occlusal trauma.
Patients on medications for systemic conditions, pregnant or lactating women, individuals with allergies to study materials, eating disorders, or excessive acid exposure
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of bioactive glass based desensitizing agent and diode laser with a standardized desensitizer Gluma in reduction of dentinal hypersensitivity |
effectiveness of desensitizing agents will be checked at zero, 1 and 3 weeks post application |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2025 |
| Date of Study Completion (India) |
15/01/2026 |
| Date of First Enrollment (Global) |
15/10/2025 |
| Date of Study Completion (Global) |
15/01/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [chaitali23pal@gmail.com].
- For how long will this data be available start date provided 26-09-2025 and end date provided 25-01-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
After CTRI registration and obtaining informed consent, prophylactic cleaning and isolation using cotton and suction will be performed. Baseline dentin hypersensitivity will be assessed using tactile stimulus and air stimulus. The response will be recorded using the Schiff sensitivity score between 0 to 3 scale. Subjects will be randomly assigned a desensitizing agent and blinded to one of three groups Group 1 – Gluma Desensitizer Group 2 – Bio-enamel Gel Group 3 – Diode Laser Hypersensitivity will be reassessed using the same stimuli at 1 and 3 weeks post-treatment. |