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

22 Jun 2022

The date of last modification

Jun 24, 2022



Application Summary


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


Trial Details


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

  • Males and females between 18-23 years
  • Healthy persons with class II malocclusion (according Angle's and British classification)
  • Overjet less than 6mm

Exclusion criteria

  • Patients with previous orthodontic treatment
  • Patients with missing upper posterior teeth
  • Patients with systematic diseases requiring regular medication
  • Patients with severely carious teeth
  • Patients with root canal failure
  • Patients with overjet more than 6mm
  • Patients with border line agreement


Primary outcome(s)

1.

Leveling and alignment measured with irregularities index using a Medit intraoral scanner.

[

4 months after intervention

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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

2022-06-01


Date of study completion


Recruitment status

Pending


Funding source

Investigator funded


Regulatory approvals

Not applicable



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)







Trial Completion details


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