| CTRI Number |
CTRI/2024/03/064374 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the efficacy of two bonding agent used for orthodontic purpose. |
|
Scientific Title of Study
|
Comparative evaluation of moisture insensitive and conventional based orthodontic adhesive systems: A Randomised Control 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 Radheya P Agrawal |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital ,Cuddalore(erstwhile Rajah Muthiah Dental College) |
| Address |
Department Of the Orthodontics, Government dental college and hospital, Cuddalore(erswhile Rajah Muthiah Dental College and hospital)Chidambaram Tamil Nadu
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9730388367 |
| Fax |
|
| Email |
agrawalradheya65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Kurunji Kumaran |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and hospital, Cuddalore |
| Address |
Department of Orthodontics, Government Dental College and hospital,Cuddalore(erstwhile Rajah Muthiah Dental College and Hospital) Chidambaram,Tamil Nadu
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
drkurinchi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Kurunji Kumaran |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and hospital, Cuddalore |
| Address |
Department of Orthodontics, Government Dental College and hospital,Cuddalore(erstwhile Rajah Muthiah Dental College and Hospital) Chidambaram,Tamil Nadu
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9865835965 |
| Fax |
|
| Email |
drkurinchi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and hospital,Cuddalore,Tamil Nadu(erstwhile Rajah Muthiah Dental College and Hospital,Chidambaram)-For Infrastructure
|
|
|
Primary Sponsor
|
| Name |
Radheya Agrawal |
| Address |
Department of Orthodontics and dentofacial orthopedics, Government Dental college and hospital , Cuddalore(erswhile Rajah Muthiah Dental College and Hospital,Chidambaram) Annamalai Nagar, Chidambaram,Tamil Nadu |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 |
| DrRadheyaP Agrawal |
Government Dental College and Hospital,Cuddalore(erstwhile Rajah Muthiah Dental College) |
Department Of Orthodontics and Dentofacial Orthopedics, Government Dental College and hospital Cuddalore(erstwhile Rajah Muthiah Dental College and Hospital Chidambaram) Annamalai Nagar,Chidambaram,Tamil Nadu
Cuddalore
TAMIL NADU |
9730388367
agrawalradheya65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College and Hospital,Cuddalore District(Erstwhile Rajah Muthiah Medical College)Annamalainagar-608002,Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transbond mip primer |
Moisture insensitive primer used for bonding of orthodontic bracket.
Frequency (Once)
Duration (6 months) |
| Comparator Agent |
Transbond xt |
Conventional primer used for bonding of orthodontic bracket.
Frequency(Once)
Duration(6 months) |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Permanent Dentition
2.Type of malocclusion including Class I, Class II & Class III
3.Adolescent or Adult Patients
4.Both Extraction and Non-Extraction Cases
|
|
| ExclusionCriteria |
| Details |
1.Teeth with facial/buccal restorations or Congenital defects
2.Teeth which are not fully erupted.
3.Dentition with occlusal interferences and deep bite hindering proper bracket Positioning.
4.Bracket failure caused by known operator error.
5.Patient with previous orthodontic treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BOND FAILURE RATE |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adhesive Remnant Index |
6 months |
|
|
Target Sample Size
|
Total Sample Size="616"
Sample Size from India="616"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
20/03/2024 |
| Date of Study Completion (India) |
30/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Orthodontic treatment with brackets generally takes 1-2 years of time. Most of the current orthodontic bonding materials are composite resins based on the bis-GMA formula. Although the use of these materials is well accepted, one major problem is the need for obtaining and maintaining a completely dry operating field throughout the bonding procedure .This is important because moisture contamination of the enamel surface is regarded as the commonest reason of bond failure. Bond failure of bracket retards treatment and is costly in terms of time, material and patient inconvenience. Hence, there was introduction of moisture resistant composite materials. The present study is designed to evaluate and compare the bond failure rate of Transbond MIP and Transbond XT as moisture insensitive and conventional materials respectively when used for direct bonding of orthodontic brackets. |