| CTRI Number |
CTRI/2025/04/084099 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative Evaluation of the Combination of Different Techniques with Microabrasion in the Treatment of Dental Fluorosis: An In Vivo Study |
|
Scientific Title of Study
|
Comparative Evaluation of the Combination of Different Techniques with Microabrasion in the Management of Fluorosis: An In Vivo 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 Ashwini Mahale |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Ahmedabad |
| Address |
Department of conservative dentistry and endodontics, govt dental college and hospital, civil hospital campus, asarwa,ahmedabad.380016
Ahmadabad
GUJARAT
380016
India |
| Phone |
7066311568 |
| Fax |
|
| Email |
ashwini97214@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Kanodia |
| Designation |
Professor |
| Affiliation |
Government Dental College and Hospital Ahmedabad |
| Address |
Department of Conservative Dentistry and Endodontics, Govt Dental College and Hospital, Asarwa, Ahmedabad-380016.
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825465861 |
| Fax |
|
| Email |
Shikhakk@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shikha Kanodia |
| Designation |
Professor |
| Affiliation |
Government Dental College and Hospital Ahmedabad |
| Address |
Department of Conservative Dentistry and Endodontics, Govt Dental College and Hospital, Asarwa, Ahmedabad-380016.
GUJARAT
380016
India |
| Phone |
9825465861 |
| Fax |
|
| Email |
Shikhakk@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics, Government Dental College and Hospital, Gujarat, 380016 |
|
|
Primary Sponsor
|
| Name |
Government Dental College and hospital Ahmedabad |
| Address |
Govt. dental college and hospital, civil hospital campus, asarwa,ahmedabad.380016 Ahmadabad GUJARAT 380016 |
| Type of Sponsor |
Other [Government Dental College] |
|
|
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 ASHWINI MAHALE |
Government dental college and Hospital Ahmedabad |
Room no 9, Dept of Conservative Dentistry and endodontics, Govt Dental College and Hospital, Civil Hospital Campus, Ahmedabad, 380016
Ahmadabad GUJARAT
Ahmadabad
GUJARAT |
7066311568
ashwini97214@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K003||Mottled teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
"Techniques Involved with Microabrasion in the Management of Fluorosis" |
Micro abrasive (Opalustre® Ultradent Products, South Jordan, UT, USA) paste approximately 1 mm of thickness was applied over the teeth.
Light pressure was applied for 60-120 sec with OpalCups bristle and micromotor handpiece.
duration - 1.5 years
|
| Comparator Agent |
MICROABRASION +LED ACTIVATED BLEACHING
|
Procedure of Group 1 followed by bleaching with bleaching agent (Opalescence boost pf 40%® Ultradent Products, South Jordan, UT, USA) 20 minutes, maximum of 3 times, activation with LED, followed by prophylactic polishing.
duration - 1.5 years
|
| Comparator Agent |
MICROABRASION+ CHEMICAL BLEACHING
|
Procedure of Group 1 followed by bleaching with bleaching agent (Opalescence boost pf 40%® Ultradent Products, South Jordan, UT, USA) 20 minutes, maximum of 3 times, followed by prophylactic polishing.
duration - 1.5 years
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- Age above 18 years
- Patients with mild to moderate fluorosis
- The patient should not be medically compromised or mentally challenged
- All maxillary anterior teeth should be present and free from any restorations |
|
| ExclusionCriteria |
| Details |
ACTIVE PERIODONTAL DISEASE, CARIOUS OR FRACTURED TEETH
-HISTORY OF SENSITIVITY IN ANTERIOR TEETH.
-PATIENTS WITH EXTRINSIC STAINS OTHER THAN FLUOROSIS
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| color parameters L1, a1, and b1 in adobe photoshop |
1 month, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| teeth sensitivity |
1 day post treatment & 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)
|
16/04/2025 |
| 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="2"
Months="0"
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
|
To evaluate aesthetic outcome of fluorotic lesions after combination of different techniques with microabrasion in the management of fluorosis OBJECTIVE •To compare the aesthetic treatment outcome of micro-abrasion and combination techniques of fluorotic lesions with mild and moderate fluorosis, (dean’s fluorosis index , 1942)]. •To quantify the tooth colour changes by photographic analysis using adobe photoshop software cs5 extended version and measuring cie l * a * b * values of each tooth at two points i.e. One at BROWN spot lesion (WSL) and the other one at sound adjacent enamel (SAE) to calculate delta E values using the CIEDE2000 formula EVALUATION CRITERIA 1) Standardized preoperative photographs captured for the evaluation of color parameters L1, a1, and b1 by Adobe Photoshop 7 software and an assessment of color enhancement at 1 month, 3 months and 6 months 2) Vas scale for teeth sensitivity immediately post operative and at 1 week.
|