| CTRI Number |
CTRI/2025/12/099303 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate Tooth Colour Improvement Using Three Bleaching Methods in Adults With Moderate Dental Fluorosis |
|
Scientific Title of Study
|
Clinical Efficacy of 17% Hydrogen Peroxide alone or in Combination with Cobalt-Tetraphenylporphyrin Complex, Functionalized with Reduced Graphene Oxide for Bleaching in Adults with Moderate Fluorosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishakha GIrdhar |
| Designation |
Post graduate student |
| Affiliation |
Shree Guru Govind Singh Tricentenary University |
| Address |
B Block, Faculty of Dental Sciences, Room no. 204, Department of Conservative Dentistry and Endodontics, Gurgaon , Harayana
Gurgaon
HARYANA
122505
India |
| Phone |
9013712245 |
| Fax |
|
| Email |
Vishakha.girdhar74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashtha Arya |
| Designation |
Professor |
| Affiliation |
Shree Guru Govind Singh Tricentenary University |
| Address |
B Block, Faculty of Dental Sciences, Room no. 204, Department of Conservative Dentistry and Endodontics, Gurgaon , Harayana
Gurgaon
HARYANA
122505
India |
| Phone |
9810761757 |
| Fax |
|
| Email |
ashtha.arya@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishakha GIrdhar |
| Designation |
Post graduate student |
| Affiliation |
Shree Guru Govind Singh Tricentenary University |
| Address |
B Block, Faculty of Dental Sciences, Room no. 204, Department of Conservative Dentistry and Endodontics, Gurgaon , Harayana
Gurgaon
HARYANA
122505
India |
| Phone |
9013712245 |
| Fax |
|
| Email |
Vishakha.girdhar74@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
B Block, Department of Conservative dentistry and Endodontics, Faculty of Dental Sciences, SGT University, Gurgoan |
| Type of Sponsor |
Research institution 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 |
| Dr Vishakha Girdhar |
Shree Guru Govind Singh Tricentenary University |
B Block, Room no. 204 , Department of Conservative Dentistry and Endodontics, SGT University
Gurgaon
HARYANA |
9013712245
vishakha.girdhar74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-SGT Dental College, Hospital and Research Institute (IEC-SGTDCHRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, (2) ICD-10 Condition: K037||Posteruptive color changes of dental hard tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
17 percent hydrogen peroxide |
Agent to be applied on anterior teeth followed by light activation for 3 cycles. Each cycle is of 8 mins. |
| Intervention |
17 percent hydrogen peroxide combined with cobalt- tetraphenylporphyrin complex, functionalized with reduced graphene oxide |
Agent to be applied on anterior teeth followed by light activation for 3 cycles. Each cycles is of 8 mins. |
| Intervention |
17 percent hydrogen peroxide combined with cobalt-tetraphenylporphyrin complex |
Agent to be applied on anterior teeth followed by light activation for 3 cycles. Each cycles is of 8 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between age group of 18-40 years.
2. Patients with moderate fluorosis in anterior teeth – score 3, classified according to the Dean Fluorosis Index- Modified (1942).
3. Tooth should have enough tooth structure for rubber dam placement.
|
|
| ExclusionCriteria |
| Details |
1. Patient with history of allergy toward any dental material.
2. Patient with fractured maxillary central or lateral incisors.
3. Patients with Class V carious lesions, smoking habit, pregnant, or lactating woman.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical efficacy of 17% hydrogen peroxide as a bleaching agent in adults presenting with moderate fluorosis stains. |
immediately after treatment, 24-hour, 72-hour and 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the clinical efficacy of 17% hydrogen peroxide combined with cobalt-tetraphenylporphyrin complex for bleaching in adults with moderate fluorosis stains |
immediately after treatment, 24-hour, 72-hour and 1 week |
| To evaluate the clinical efficacy of 17% Hydrogen Peroxide combined with Cobalt- Tetraphenylporphyrin Complex, functionalized with Reduced Graphene Oxide for bleaching in adults with moderate fluorosis stains |
immediately after treatment, 24-hour, 72-hour and 1 week |
| To compare and identify the most effective bleaching agent for treating moderate fluorosis stains in adults. |
immediately after treatment, 24-hour, 72-hour and 1 week |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
01/01/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 clinical study evaluates the effectiveness of a low-concentration bleaching agent—17 percent hydrogen peroxide—used alone and in combination with a cobalt-tetraphenylporphyrin (CoTPP) complex functionalized with reduced graphene oxide (RGO) for treating moderate dental fluorosis in adults. Fluorosis causes intrinsic enamel discoloration, and current high-concentration bleaching agents may induce sensitivity and enamel changes. The CoTPP/RGO nanocomposite acts as a catalyst to enhance peroxide activity while minimizing side effects. Forty-five patients will be divided into three groups and assessed for shade improvement, sensitivity, and satisfaction using VAS scales. The study aims to identify the most effective, safer bleaching approach. |