| CTRI Number |
CTRI/2026/03/105808 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Low-Level Laser Therapy, Gluma Desensitizer, and Ultra EZ Gel on Tooth Sensitivity and Shade Stability after In-Office Bleaching: A Randomized Clinical Trial |
|
Scientific Title of Study
|
Effect Of Various Prior Desensitization methods on Post Operative Sensitivity and colour stability induced due to In-Office Bleaching - A clinical Randomized control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Rayavarapu |
| Designation |
PG Student |
| Affiliation |
Kamineni Institute of dental sciences |
| Address |
Department: Conservative Dentistry and endodontics,
Room no: 7,
Kamineni institute of dental sciences, narketpalli
Nalgonda
TELANGANA
508254
India |
| Phone |
07032996625 |
| Fax |
|
| Email |
divyarayavarapu99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jaya Nagendra Krishna |
| Designation |
Post Graduate |
| Affiliation |
Kamineni Institute of dental sciences |
| Address |
Department: Conservative Dentistry and Endodontics,
Room no: 7,
Kamineni institute of dental sciences, narketpalli
Nalgonda
TELANGANA
508254
India |
| Phone |
9701994087 |
| Fax |
|
| Email |
mjnkendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Rayavarapu |
| Designation |
PG Student |
| Affiliation |
Kamineni Institute of dental sciences |
| Address |
Department: Conservative Dentistry and Endodontics,
Room no: 07,
Kamineni institute of dental sciences, Narketpalli
Nalgonda
TELANGANA
508254
India |
| Phone |
07032996625 |
| Fax |
|
| Email |
divyarayavarapu99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kamineni Institute of Dental Sciences, Narketpalli, Nalgonda- 508254 |
|
|
Primary Sponsor
|
| Name |
Divya Rayavarapu |
| Address |
Department: Conservative Dentistry and Endodontics,
Room no: 07,
Kamineni institute of dental sciences, Narketpalli |
| 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 Jaya Nagendra Krishna |
Kamineni Institute of dental sciences |
Department: Conservative Dentistry and Endodontics,
Room no: 07,
Kamineni institute of dental sciences, Narketpalli
Nalgonda
TELANGANA |
9701994087
divyarayavarapu99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics commitee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
In-Office bleaching |
Gluma desensitizer and ultra EZ gel |
| Intervention |
In-office bleaching |
Low-Level Laser Therapy |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Mild to Moderate dental fluorosis present
2. The subjects were enrolled in this study only after they willingly signed the informed consent
form |
|
| ExclusionCriteria |
| Details |
1.Severe dental Fluorosis
2. With out any periodontal destruction, carious lesion, and gingival recession.
3. Frequent Smokers, tobacco chewers. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dentinal sensitivity reduction (VAS scores at various time points) |
Dentinal sensitivity reduction (VAS scores at various time points) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Color/shade change stability post-bleaching |
|
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Only at email divyarayavarapu99@gmail.com
- For how long will this data be available start date provided 19-01-2026 and end date provided 31-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study evaluated the effectiveness of Low-Level Laser Therapy (LLLT), Gluma Desensitizer, and Ultra EZ Gel in reducing postoperative sensitivity after in-office bleaching. Twenty-seven patients were randomly divided into three groups. Sensitivity was measured using the VAS at multiple time points, and tooth shade was assessed before and after bleaching. Results showed that LLLT was most effective in minimizing sensitivity, followed by Gluma, with Ultra EZ showing the highest sensitivity scores. All groups achieved significant whitening, with LLLT providing slightly superior shade stability. The study concluded that LLLT is the most effective method for reducing sensitivity while maintaining bleaching efficacy, with Gluma and Ultra EZ being less effective but still beneficial. |