| 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
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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 |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Army Dental Centre Research and Referral |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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, |
|
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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. |
|
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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).
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
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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 |
|
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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 |
|
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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 |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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