Home » Trials » SLCTR/2022/015
Comparative evaluation of conventional double slot brackets versus single slot brackets for correction of class II malocclusion in a sample of Erbil city
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SLCTR Registration Number
SLCTR/2022/015
Date of Registration
The date of last modification
Oct 05, 2022
Scientific Title of Trial
Comparative evaluation of conventional double slot brackets versus single slot brackets for correction of class II malocclusion in a sample of Erbil city
Public Title of Trial
Comparative evaluation of conventional double slot brackets versus single slot brackets for correction of class II malocclusion in a sample of Erbil city
Disease or Health Condition(s) Studied
Class II malocclusion
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1269-0078
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
What is the effect of single slot brackets versus conventional double slot brackets for the correction of Class II malocclusion in adults between 18-23 years?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Orthodontic Department, College of Dentistry, Hawler Medical University, Iraq. Randomization: Simple randomization Blinding: Participants and healthcare providers Intervention: After baseline assessment with Cone Beam CT (CBCT) scan and salivary samples for biomarkers. Patients will be placed with orthodontic brackets in the way of direct bonding (same bracket for both groups) called double slot for all patients. After leveling and alignment we start upper retraction for managing class II patients.
Single slot bracket The sequence sizes of wire for single slot is 0.14 ,0.16 ,0.18, 0.20 round Nickle titanium these sequence every 30 days. After 0.20 stainless steel for 30 days and then we start with rectangular wires 0.16 x 0.25 .0,18 x 0.2 Nickle titanium and 0.16 x 0.25 stainless steel and the last working wire 0.18 x 0.25 for retraction .
For double slot bracket 0.12 nickle titanium on gingival slot and 0.14 nickle titanium on occlusal slot for 60 days. Then 0.14 nickle titanium on gingival and o.16 nickle titanium on occlusal slo for 30 days Then 0.16 nickle titanium on gingival slot and 0.18 nickle titanium nickle titanium on occlusal slot after that we starting with 0.18 on gingival and 0.20 nickle titanium on occlusal then we will follow the sequence of arch wire with remain 0.18 nickle titanium on gingival slot with 0.20 stainless steel on occlusal then we will start with rectangular wires for double slot we will insert two wire 0.016 x 0.25 nickle titanium on gingival and occlusal slot, the last sequence of wire for retraction we insert 0.16 x 0.25 on gingival slot and 0.018 x 0n occlusal slot both stainless steel . All wires are manufactured from same company (American orthodontics) for standardisation.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
Leveling and alignment measured with irregularities index using a Medit intraoral scanner. |
[ 4 months after intervention ] |
2.
Pain using the visual analogue scale |
[ 72 hours after bracket placement ] |
3.
Root resorption measured using glutamate levels from saliva and 3D imaging using CBCT scan. |
[ 6 months and 1 year ] |
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Secondary outcome(s)
1.
None |
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Target number/sample size
40 patients, 20 in each group
Countries of recruitment
Iraq
Anticipated start date
2022-06-29
Anticipated end date
2023-07-23
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Investigator funded
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2021-12-14
Approval number
32-2022
Details of Ethics Review Committee
Name: | Research Ethics Committee/ Hawler Medical University, college of dentistry |
Institutional Address: | Hawler Medical University, college of dentistry, Iraq Erbil city (postal code 4400), 60 m street bridge of shorsh |
Telephone: | +9647504481247 |
Email: | zana.qadir@hmu.edu.krd |
Contact person for Scientific Queries/Principal Investigator
Bayan Abdulla Saber
College of Dentistry, Hawler Medical University
009647504494259
Bayan.hasan@hmu.edu.krd
Contact Person for Public Queries
Bayan Abdulla Saber
College of Dentistry, Hawler Medical University
009647504494259
Bayan.hasan@hmu.edu.krd
Primary study sponsor/organization
College of Dentistry, Hawler Medical University
100 m Street, Beside Rizgary Teaching Hospital, Erbil, Iraqi Kurdistan Region
+964 66 2273384
info@hmu.edu.krd
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results