Clinical trial NCT02427282: Distalization by Miniscrew
Official title: Miniscrew-supported Versus Standard Frog Molar Distalizing Appliances (Clinical Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Distalization by Miniscrews
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: mesial migration of anterior teeth measured in millimeter and angles by using cone beam computerized tomography
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: