| CTRI Number |
CTRI/2025/07/090115 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effectiveness of laser-assisted tooth whitening using a professional bleaching gel in adults, with color changes assessed through advanced artificial intelligence-based analysis. |
|
Scientific Title of Study
|
Evaluation of Efficacy of Tooth Bleaching with Diode Laser using AI-Driven Colorimetric analysis- A Prospective Interventional 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 |
Dr Panshul Kharche |
| Designation |
3rd Year Post Graduate |
| Affiliation |
NIMS Dental College |
| Address |
Department of Peridontology,NIMS Dental College,NIMS Unvieristy, Delhi - Jaipur Expressway Highway, Jugalpura
Department of Peridontology,NIMS Dental College,NIMS Unvieristy, Delhi - Jaipur Expressway Highway, Jugalpura
Jaipur
RAJASTHAN
303121
India |
| Phone |
08296075475 |
| Fax |
|
| Email |
panshulkharche@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neetha Bhargava |
| Designation |
Head of Department |
| Affiliation |
NIMS Dental College |
| Address |
Department of peridontology,NIMS Dental College,NIMS Univeristy, Delhi - Jaipur Expressway Highway, Jugalpura
Department of peridontology,NIMS Dental College,NIMS Univeristy, Delhi - Jaipur Expressway Highway, Jugalpura
Jaipur
RAJASTHAN
303121
India |
| Phone |
8050497427 |
| Fax |
|
| Email |
panshulkharche8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Panshul Kharche |
| Designation |
3rd Year Post Graduate |
| Affiliation |
NIMS Dental College |
| Address |
Department of peridontology,NIMS Dental College,NIMS Univeristy, Delhi - Jaipur Expressway Highway, Jugalpura
Department of peridontology,NIMS Dental College,NIMS Univeristy, Delhi - Jaipur Expressway Highway, Jugalpura
Jaipur
RAJASTHAN
303121
India |
| Phone |
08296075475 |
| Fax |
|
| Email |
panshulkharche@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of peridontology,NIMS Dental College,NIMS Univeristy, Delhi - Jaipur Expressway Highway, Jugalpura,Jaipur,Rajasthan,INDIA 303121 |
|
|
Primary Sponsor
|
| Name |
Dr Panshul Kharche |
| Address |
NIMS Dental College , NIMS UNIVERSITY , JAIPUR - DELHI HIGHWAY,JUGALPURA, JAIPUR, RAJASTHAN,INDIA 303121 |
| Type of Sponsor |
Other [researcher] |
|
|
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 Neetha Bhargava |
NIMS Dental College and Hospital |
Department of Periodontology,NIMS Dental College, NIMS UNIVERSITY, Jugalpura, Delhi Jaipur HIghway 17C
Jaipur
RAJASTHAN |
8050497427
panshulkharche@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| office of the institutional ethics committee, NIMS university rajasthan jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All participants were systemically healthy with no significant family histories |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AI Colorimetry Analysis |
Certainly! Here is the **reframed version** of your sentence with improved clarity, flow, and sophistication:
To evaluate the efficacy of tooth bleaching using 40% hydrogen peroxide activated by an 810 nm diode laser, applied for 5 minutes at 5-minute intervals, repeated three times within a single clinical visit. The change in tooth color was assessed using colorimetric analysis through an AI-driven application, Matisse AI.
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patient with age 18 years to 45 years
Both male and female in the study
Patients with type 2 and type 3 modified deans fluorosis classification
Patients having fluorosis and hypersentitvity with VAS score above 3 in the anterior region
Patients residing in the fluoride belts region such as Rajasthan
|
|
| ExclusionCriteria |
| Details |
patient having a carious lesion in the anterior region
patient with periodontal defects
patient diagnosed with chronic generalized periodontitis
patients having prosthesis in the anterior region such as crowns and veneers
patients having Ellis fracture in anterior region
patient having developmental anamolies such as amelogenesis imperfecta and dentinogenesis imperfecta |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Here’s your revised text with improved clarity, structure, and a professional tone:
There was a slight decrease in mean chroma observed three weeks post-operatively; however, this change was not statistically significant (p = 0.267). In contrast, the lightness (L value) showed a significant increase after the procedure (p = 0.00004), indicating a perceptible brightening effect of the teeth.
|
Here is a polished and cohesive version of your results summary:
There was a slight reduction in mean chroma following the procedure; however, this change was not statistically significant (p = 0.267). In contrast, a significant increase in lightness (L value) was observed post-operatively (p = 0.00004), indicating a marked improvement in tooth brightness after three weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the accuracy & reliability of the AI-driven application for colorimetry analysis |
Pretreatment & 3 weeks after posttreatment |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
14/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="18" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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 prospective interventional single-arm clinical study aims to evaluate the effectiveness of diode laser-assisted tooth bleaching and assess the accuracy of an AI-driven colorimetry application for tooth shade analysis. A total of 30 adult participants with vital anterior teeth requiring cosmetic whitening will undergo a single session of in-office bleaching using a 35% hydrogen peroxide gel activated with a diode laser. Pre- and post-treatment tooth shades will be recorded using both a conventional visual shade guide and an AI-based colorimetry tool. The primary objective is to measure the change in tooth color following laser bleaching using AI-based analysis. The secondary objective is to evaluate the performance of the AI application in terms of accuracy and agreement with visual shade assessment, as well as its feasibility in a clinical workflow. This study seeks to explore the integration of artificial intelligence in objective aesthetic evaluation and validate its application as a digital support tool in cosmetic dentistry. |