Distalization by Miniscrew (AU)
|ClinicalTrials.gov Identifier: NCT02427282|
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : May 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Distalization by Miniscrews||Device: miniscrew-supported Frog molar distalizing appliance Device: Standard Frog molar distalizing appliance||Phase 1|
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;
- All the subjects had an age range from 11 to 16 years with a mean of ±13.5 years.
- All the subjects had skeletal Class 1 or mild skeletal Class 2 due to maxillary excess.
- All the subjects had bilateral Class II molar relationship.
- All subjects were free from any dental anomalies.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Miniscrew-supported Versus Standard Frog Molar Distalizing Appliances (Clinical Study)|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||March 2015|
Active Comparator: MS. Frog
miniscrew-supported frog molar distalizing appliance
Device: miniscrew-supported Frog molar distalizing appliance
miniscrew 10mm length and 1.7mm diameter FORESTADENT company
Other Name: Skeletal Frog
Experimental: Stand. Frog
Standard Frog appliance
Device: Standard Frog molar distalizing appliance
Nance buttons attached to first premolars band
Other Name: Conventional Frog
- mesial migration of anterior teeth measured in millimeter and angles by using cone beam computerized tomography [ Time Frame: 6months ]pretreatment and postdistalization records as cone beam computerized tomography and cast analysis