| CTRI Number |
CTRI/2025/05/086536 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Does microetching help tooth Band Stick Better? A study on tooth band retention in young patients with braces. |
|
Scientific Title of Study
|
A comparative evaluation of orthodontic molar band retention with and without microetching: A Randomized Controlled 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 |
Jay Thakkar |
| Designation |
Postgraduate Resident |
| Affiliation |
Faculty of dental science, Dharmsinh Desai University |
| Address |
No.6,PG Division,Department of Orthodontics and Dentofacial Orthopedics,Faculty of Dental Science,Dharmsinh Desai University,Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
8690320083 |
| Fax |
|
| Email |
drjay4ortho@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aakash Shah |
| Designation |
Professor, HOD, PG and PhD guide |
| Affiliation |
Faculty of dental science, Dharmsinh Desai University |
| Address |
No.6,PG Division,Department of Orthodontics and Dentofacial Orthopedics,Faculty of Dental Science,Dharmsinh Desai University,Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
9825373777 |
| Fax |
|
| Email |
aakash1172@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jay Thakkar |
| Designation |
Postgraduate Resident |
| Affiliation |
Faculty of dental science, Dharmsinh Desai University |
| Address |
No.6,PG Division,Department of Orthodontics and Dentofacial Orthopedics,Faculty of Dental Science,Dharmsinh Desai University,Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
8690320083 |
| Fax |
|
| Email |
drjay4ortho@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental science Dharmsinh Desai university,NADIAD,Kheda GUJARAT 387001 INDIA |
|
|
Primary Sponsor
|
| Name |
Jay Thakkar |
| Address |
No.6,PG Division,Department of Orthodontics and Dentofacial Orthopedics,Faculty of Dental Science,Dharmsinh Desai University,Nadiad,Kheda,GUJARAT,387001,INDIA |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Faculty of Dental science Dharmsinh Desai university |
No.6,PG Division,Department of Orthodontics and Dentofacial Orthopedics,Faculty of Dental Science,Dharmsinh Desai University,Nadiad. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jay Thakkar |
Faculty of Dental science, Dharmsinh Desai University |
No.6,PG Division,Department of Orthodontics and Dentofacial Orthopedics,Faculty of Dental Science,Dharmsinh Desai University,Nadiad.
Kheda
GUJARAT |
8690320083
drjay4ortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Faculty of Dental Science,Dharmsinh Desai University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
conventional band cemented on one side of arch |
the teeth will be cleaned using a pumice slurry, washed, and dried with an air syringe. Appropriately sized first molar bands will be selected, adapted to the teeth, and trial-fitted. These bands will then be removed, dried thoroughly, and cemented using conventional glass ionomer cement mixed according to the manufacturer’s instructions. Each pair of bands in the same arch will be cemented with a single mix of the material. During the banding process, the teeth will be isolated with cotton rolls and kept dry with an air syringe, while any excess material will be removed and will be assessed every 4 week for 18 months |
| Comparator Agent |
Microetched band cemented on one side of arch |
the teeth will be cleaned using a pumice slurry, washed, and dried with an air syringe. Appropriately sized first molar bands will be selected, adapted to the teeth, and trial-fitted. These bands will then be removed, dried thoroughly, and cemented using conventional glass ionomer cement mixed according to the manufacturer’s instructions. Each pair of bands in the same arch will be cemented with a single mix of the material. During the banding process, the teeth will be isolated with cotton rolls and kept dry with an air syringe, while any excess material will be removed and will be assessed every 4 week for 18 months |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients receiving fixed appliance treatment.
Treatment involving the cementation of at least one pair of bands on first permanent molar teeth in the same arch.
|
|
| ExclusionCriteria |
| Details |
Patients in which the treatment plan includes the first permanent molar in their appliance design.
Patient having primary dentition
Partially erupted any Permanent first molar maxilla and mandible
Grossly decayed any Permanent first molar maxilla and mandible
Patients with cleft lip and palate and Syndromes
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number and type of band failure |
4 weeks for 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To assess the survival times of micro-etched molar bands in relation to conventional molar bands. |
4 weeks for 18 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 3 |
|
Date of First Enrollment (India)
|
10/05/2025 |
| 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="1"
Months="6"
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
|
AIM · The aim of the present study was to investigate retention and stability of micro-etched molar bands and conventional molar bands in a prospective, randomized, controlled trial.
MATERIALS AND METHODOLOGY This study with a split-mouth design will be conducted in the Department of Orthodontics and Dentofacial Orthopedics, Faculty of Dental Science, Dharmsinh Desai University, Nadiad, Gujarat. A total of 75 patients resulting in a total of 300 molar bands cemented, which included 150 micro-etched bands and 150 conventional bands with side allocation determined through Block Randomization. Band retention will be checked at 4-week intervals, and loose bands will be deemed as failures. The date of failure will be recorded as accurately as possible; if not identifiable, the date of the patient’s department visit will be noted. The study will track all cases either to the end of treatment or a maximum period of 1 year and 6 months (540 days), after which molar bands will be censored for patients whose bands have not failed. STATISTICAL ANALYSIS The statistical analysis was conducted using Chi-Square test using SPSS 8.0 to evaluate the influence of various explanatory variables on band failure. Failure rates of microetched and conventional bands are compared amongst subjects and among bands. |