Distalization by Miniscrew

Phase 1

Completed

• Conditions: Distalization by Miniscrews
• Interventions: Device: Standard Frog molar distalizing appliance; Device: miniscrew-supported Frog molar distalizing appliance

• Registration Number: NCT02427282
• Lead Sponsor: Ain Shams University

Brief Summary

This study aimed to compare the effectiveness and efficiency of miniscrew-supported and standard frog molar distalizing appliances.

Detailed Description

A prospective randomized clinical trial study was carried out on twenty healthy Egyptian subjects, each required molar distalization as part of their comprehensive orthodontic treatment. The subjects were selected and treated at the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Ain-Shams University.

The inclusion criteria in this subject selection in this study was as follows;

1. All the subjects had an age range from 11 to 16 years with a mean of ±13.5 years.

2. All the subjects had skeletal Class 1 or mild skeletal Class 2 due to maxillary excess.

3. All the subjects had bilateral Class II molar relationship.

4. All subjects were free from any dental anomalies.

5. All subjects had good oral hygiene. The exclusion criteria in this study was as follows; 1- Missing permanent teeth with exception of 3rd molar. 2- Previous orthodontic treatment. 3- Systemic disease that may influence orthodontic treatment and drug intake. 4- Periodontal disease. 5- Functional mandibular deviations and facial asymmetry. 6- History of parafunctional habits.

The subjects were equally and randomly divided into two groups; group A and group B which included ten subjects per group. These groups were classified according to the type of distalizer utilized:

* Group A: included ten subjects utilizing the conventional frog molar distalizing appliance (CF).

* Group B: included ten subjects utilizing the Miniscrews-supported frog molar distalizing appliance (MSF)

The pretreatment and post-distalization Database Records All subjects had the following records; a clinical diagnostic sheet, orthodontic study cast (according to ABO index), extraoral and intraoral photographs, and CBCT.

These records were obtained at T1 before distalization and at T2 after distalization.

The study protocol was approved by the local ethics committee, faculty of dentistry, Ain-Shams University. Before commencing with treatment, all the subjects and their guardians received a full explanation of the treatment protocol. After which they were asked to sign a detailed written consent.

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2015-04
• Study First Submitted: 2015-04-19
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-28
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. All the subjects had an age range from 11 to 16 years with a mean of ±13.5 years.
2. All the subjects had skeletal Class 1 or mild skeletal Class 2 due to maxillary excess.
3. All the subjects had bilateral Class II molar relationship.
4. All subjects were free from any dental anomalies.
5. All subjects had good oral hygiene.

Exclusion Criteria

1. Missing permanent teeth with exception of 3rd molar.
2. Previous orthodontic treatment.
3. Systemic disease that may influence orthodontic treatment and drug intake.
4. Periodontal disease.
5. Functional mandibular deviations and facial asymmetry.
6. History of parafunctional habits.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stand. Frog	Standard Frog molar distalizing appliance	Standard Frog appliance
MS. Frog	miniscrew-supported Frog molar distalizing appliance	miniscrew-supported frog molar distalizing appliance

Primary Outcome Measures

Name	Time	Method
mesial migration of anterior teeth measured in millimeter and angles by using cone beam computerized tomography	6months	pretreatment and postdistalization records as cone beam computerized tomography and cast analysis