| CTRI Number |
CTRI/2021/04/032951 [Registered on: 20/04/2021] Trial Registered Prospectively |
| Last Modified On: |
19/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare time taken to stick metal orthodontic bracket on tooth surface and bracket failure rate between 3M APC flash free and APC Plus brackets. |
|
Scientific Title of Study
|
COMPARATIVE ASSESSMENT OF BONDING TIME AND BRACKET FAILURE RATE USING APC FLASH-FREE AND APC PLUS ADHESIVE METAL BRACKETS FOR ORTHODONTIC BONDING: A SPLIT MOUTH RANDOMIZED CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinaykumar Shah |
| Designation |
Post Graduate Student |
| Affiliation |
K.M.Shah Dental College & Hospital, Sumandeep Vidyapeeth University |
| Address |
No.4 Department Of Orthodontics
K.M.Shah Dental College and Hospital
Near Dhiraj General Hospital Waghodia Road
Vadodara 391760
No.4 Department Of Orthodontics
K.M.Shah Dental College and Hospital
Near Dhiraj General Hospital Waghodia Road
Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7567736733 |
| Fax |
|
| Email |
shahvinay33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narayan Kulkarni |
| Designation |
Professor |
| Affiliation |
K.M.Shah Dental College & Hospital, Sumandeep Vidyapeeth University |
| Address |
No 4 Department Of Orthodontics
K.M.Shah Dental College and Hospital
Near Dhiraj General Hospital Waghodia Road
Vadodara 391760 Gujarat
No 4 Department Of Orthodontics
K.M.Shah Dental College and Hospital
Near Dhiraj General Hospital Waghodia Road
Vadodara 391760 Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9601949590 |
| Fax |
|
| Email |
drorthonaru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinaykumar Shah |
| Designation |
Post Graduate Student |
| Affiliation |
K.M.Shah Dental College & Hospital, Sumandeep Vidyapeeth University |
| Address |
No 4 Department Of Orthodontics
K.M.Shah Dental College and Hospital
Near Dhiraj General Hospital Waghodia Road
Vadodara
No 4 Department Of Orthodontics
K.M.Shah Dental College and Hospital
Near Dhiraj General Hospital Waghodia Road
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7567736733 |
| Fax |
|
| Email |
shahvinay33@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.M.Shah Dental College And Hospital, Vadodara 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Vinaykumar Shah |
| Address |
D-303 Oakland Stay Hostel
Near Gayatri Mandir
Waghodia Road, Vadodara |
| 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 Vinaykumar Shah |
K.M.Shah Dental College and Hospital |
Department Of Orthodontics and Dentofacial Orthopaedics,
K.M.Shah Dental College and Hospital Vadodara,391760
Vadodara
GUJARAT |
7567736733
shahvinay33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental Malocclusion. (Irregular teeth) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
APC Flash free Metal Bracket
|
Orthodontic Metal brackets of 3M company for orthodontic treatment |
| Comparator Agent |
APC Plus Adhesive Metal brackets |
3M Orthodontic metal bracket for orthodontic treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Participant age between 18 to 30 years. Below 18years of age individuals children may not follow the instructions properly and that may be the other confounding factor for debonding of brackets, and above 30 years of age participant’s periodontal health might get poor and treatment time may be longer for their completion of treatment than the study time.
2. Full permanent dentition.
3. No previous orthodontic treatment with fixed appliances.
4. Teeth with sound, noncarious buccal enamel and no pre-treatment with chemical agents such as hydrogen peroxide.
5. Participant’s with malocclusion whose treatment time not exceeds 15 months duration will be included.
|
|
| ExclusionCriteria |
| Details |
1. Participants not willing to be a part of the study.
2. Participant not giving inform consent.
3. Participants having congenital syndromes, developmental anomalies and craniofacial abnormalities and obvious facial asymmetry.
4. Participants having any prosthetic replacement in the region of 2nd premolar to contralateral premolar in both upper and lower arches.
5. Orthognathic surgery as part of their treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate bonding time and bracket failure rate of APC flash free and APC Plus Adhesive Metal Brackets. |
Every Month Appointment Approx.4weeks. Till 12 months Bracket Failure assess from the bonding time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the mode of bond failure of APC flash free and APC Plus adhesive metal brackets. |
Brackets will be evaluated every 4 weeks till 12 months at time point of 4-8-12-16-20....52 weeks. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/04/2021 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Bonding of APC Plus and APC Flash free adhesive bracket in the participants. Evaluation of Bonding time and bracket failure rate among both. Till 12 months Bracket failure will be evaluated. And Bond failure will be seen in debonded bracket. Appointment time will be schedule to 4 weeks interval. |