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CTRI Number  CTRI/2024/04/065849 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 15/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Analyzing the rate of detachment of orthodontic brackets both with and without using a thin layer of adhesive material in a comparative manner  
Scientific Title of Study   Comparative evaluation of rate of debonding in orthodontic bonding carried out with and without primer: a randomized clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Maj Prashanth R 
Designation  Resident 
Affiliation  Army Dental Cenre, Research and Referral 
Address  Department of Orthodontics and Dentofacial Orthopaedics, Army Dental Centre, Research and Referral, Dhaula Kuon, Delhi Cantt,New Delhi

South
DELHI
110010
India 
Phone  09597735027  
Fax    
Email  mailstoprash@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Brig Sukhbir Singh Chopra 
Designation  HOD 
Affiliation  Army Dental Cenre, Research and Referral 
Address  Department of Orthodontics and Dentofacial Orthopaedics, Army Dental Centre, Research and Referral, Dhaula Kuon, Delhi Cantt,New Delhi

South
DELHI
110010
India 
Phone  9402707591  
Fax    
Email  drsschopra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Brig Sukhbir Singh Chopra 
Designation  HOD 
Affiliation  Army Dental Cenre, Research and Referral 
Address  Department of Orthodontics and Dentofacial Orthopaedics, Army Dental Centre, Research and Referral, Dhaula Kuon, Delhi Cantt,New Delhi

South
DELHI
110010
India 
Phone  9402707591  
Fax    
Email  drsschopra@gmail.com  
 
Source of Monetary or Material Support  
Army Dental Centre Research and Referral 
 
Primary Sponsor  
Name  Army Dental Centre Research and Referral 
Address  Army Dental Centre Research and Referral, Dhaula kuan, Delhi Cantt, New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Maj Prashanth R  Army Dental Centre Research and Referral  Department of Orthodontics and Dentofacial Orthopaedics ,Army Dental Centre Research and Referral Dhaula Kuan, New Delhi
South
DELHI 
09597735027

mailstoprash@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Army Dental Centre Research and Referral  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (2) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional fixed direct orthodontic treatment with primer application for bonding the brackets   In the intervention group, the rate of debonding in the fixed orthodontic treatment with the application of primer will be evaluated for 6 months and the first debonding will be noted. 
Comparator Agent  Conventional fixed direct orthodontic treatment without primer application for bonding the brackets   In the comparator group, the rate of debonding in the fixed orthodontic treatment without the application of primer will be evaluated for 6 months and the first debonding will be noted. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Skeletal Class I malocclusion requiring fixed orthodontic treatment.
2. Patients with full complement of teeth till first molar in both maxillary and mandibular arches.
3. No deleterious habits.
4. Cases with optimal overjet and overbite.
5. Patient aged 15-30 years.
 
 
ExclusionCriteria 
Details  1. Patient involved in aggressive sports.
2. Patients with congenital enamel defects.
3. Patients with buccal surface caries.
4. Patients with congenitally missing teeth.
5. Teeth with anomalies of crown size or shape (peg laterals).
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Rate of debonding in direct orthodontic bonding carried out in patients with and without the use of primer  01 month 02 month 03 month 04 month 05 month 06 month 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the prevelance of debonding by using primer and not using primer   01 month 02 month 03 month 04 month 05 month 06 month 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   30/04/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Orthodontic treatment focuses on dentoalveolar and orthopaedic corrections to restore form, function and esthetics. The brackets form an integral component of fixed orthodontic therapy. The edgewise bracket system was introduced by E.H. Angle in 1928. Initially, these brackets were welded to orthodontic bands and then cemented over the tooth. Later, the technique of acid etching paved way for bonding the brackets directly to the teeth. The bonding materials have evolved significantly since the time of their introduction by Buonocore in 1955 and currently, fourth generation bonding agents are in use in orthodontic bonding. The optimal bond strength required for orthodontic adhesive should be at least 6 – 8 MPa. The use of primer is considered to produce better bonding and ensures high bond strength for treatment success. However, few studies have reported equitable bonding success rate in bonding without primer. Such studies on bonding without the use of primer have usually been carried out under in-vitro conditions or with low sample size but inconclusive results. Thus, controversy in the literature exists regarding the bond failure of brackets with and without the use of primer. Considering the constancy of other factors involved in bond failure  such as age, patient compliance, type of primer, curing lamp and bracket material, bonding with and without primer can be additional factor in determining the success of bonding. This study endeavours to add to the existing sparse literature on this topic of bond failure rate in direct bonding carried out with and without the use of primer. The study will be carried out,  under in-vivo conditions, as a randomized clinical trial to bridge the knowledge gap and provide evidence for clinical usage.

 


 
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