| CTRI Number |
CTRI/2024/03/064772 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of efficacy of three different concentrations of carbamide peroxide with reduced application time for at home bleaching in terms of color change and tooth sensitivity |
|
Scientific Title of Study
|
Comparative Evaluation of Effectiveness of At-Home Dental Bleaching Using Different Concentrations Of Carbamide Peroxide for Different Time Intervals: 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 |
Dr Nandani Kumari |
| Designation |
Junior Resident |
| Affiliation |
Aligarh Muslim University |
| Address |
OPD-7, PG Clinic, Department of Conservative Dentistry and Endodontics, AMU Campus, Medical Rd, Civil Lines, Aligarh, Uttar Pradesh 202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8368101925 |
| Fax |
|
| Email |
nandanikumari2030@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. S.K. MISHRA |
| Designation |
professor |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Conservative Dentistry and Endodontics, AMU Campus, Medical Rd, Civil Lines, Aligarh, Uttar Pradesh 202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9358203449 |
| Fax |
|
| Email |
drsurendrakmishra69@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandani Kumari |
| Designation |
Junior Resident |
| Affiliation |
Aligarh Muslim University |
| Address |
OPD-7, PG Clinic, Department of Conservative Dentistry and Endodontics, AMU Campus, Medical Rd, Civil Lines, Aligarh, Uttar Pradesh 202002
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8368101925 |
| Fax |
|
| Email |
nandanikumari2030@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. ZIAUDDIN AHMAD DENTAL COLLEGE, ALIGARH MUSLIM UNIVERSITY , ALIGARH |
|
|
Primary Sponsor
|
| Name |
DR ZIAUDDIN AHMAD DENTAL COLLEGE AMU ALIGARH |
| Address |
OPD-7,PG clinic, Department of Conservative Dentistry and Endodontics, Dr. Ziauddin Ahmad Dental College and Hospital, AMU Campus, Medical Road, Aligarh |
| Type of Sponsor |
Government medical 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 Nandani Kumari |
Dr. Ziauddin Ahmad Dental College and Hospital |
OPD 7 , PG CLINIC ,DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS ,AMU Campus, Medical Rd, Civil Lines, Aligarh, Uttar Pradesh 202002
Aligarh
UTTAR PRADESH |
8368101925
nandanikumari2030@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Faculty of Medicine, A.M.U., Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K037||Posteruptive color changes of dental hard tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
carbamide peroxide |
35% carbamide peroxide, topically over the teeth in a gel form in a bleaching tray , 30 min daily for 3 weeks |
| Comparator Agent |
carbamide peroxide |
carbamide peroxide gel 10% and 22% , topically 30 min daily for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Vital teeth free from carious and non-carious lesions in maxillary anterior lacking periodontal diseases.
2. Minimum baseline shade A2 |
|
| ExclusionCriteria |
| Details |
1. Previous history of tooth sensitivity.
2. Previous dental whitening treatment.
3. Serious dental discoloration.
4. Visible cracks.
5. Pregnant and breast-feeding females.
6. Smokers |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate effectiveness of three different concentrations(10%, 22%, 35%) of carbamide peroxide with reduced application time for at-home bleaching in terms of colour change. |
1st week, 2nd week, 3rd week, 1 month after 3rd week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evaluate tooth sensitivity caused by carbamide peroxide gel ( 10%, 22% & 35%) |
Day 1 to Day 21 |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
02/04/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
Treatment Protocol: Two weeks prior to the bleaching procedure, calculus or plaque deposits will be removed using ultrasonic scaler. Buccal/labial surfaces of teeth will be polished using prophylaxis paste and polishing cup fitted on a low-speed hand piece. All participants will be advised to brush their teeth twice a day using toothpaste not containing any bleaching compound within its ingredients throughout the study period. Baseline shades will be recorded for each patient using Vita classical shade guide and Vita bleach guide 3D MASTER in shade guide units. Shade measurements will be recorded for the middle third of labial surfaces of each maxillary anterior teeth. Alginate impression of both the arches of each participant will be obtained to prepare stone molds and trays will be fabricated for both the arches. Trays will be properly trimmed, 2 mm from the gingival margin and will be tested in patient and adjusted as needed. Application of the bleaching material will be demonstrated to each participants. Participants will be instructed to use the tray holding the respective concentration of carbamide peroxide for the specified time intervals according to the groups in which they will be allocated. Each treatment will be performed for 3 weeks. Participants will be instructed to fill out the Visual analogue scale form daily throughout the treatment given to them at beginning of the treatment. The color evaluation will be repeated and recorded at the end of first, second and third week and a month after a treatment’s conclusion. |