Distalization by Miniscrew

NCT ID: NCT02427282

Last Updated: 2015-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Distalization by Miniscrews

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MS. Frog

miniscrew-supported frog molar distalizing appliance

Group Type ACTIVE_COMPARATOR

miniscrew-supported Frog molar distalizing appliance

Intervention Type DEVICE

miniscrew 10mm length and 1.7mm diameter FORESTADENT company

Stand. Frog

Standard Frog appliance

Group Type EXPERIMENTAL

Standard Frog molar distalizing appliance

Intervention Type DEVICE

Nance buttons attached to first premolars band

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

miniscrew-supported Frog molar distalizing appliance

miniscrew 10mm length and 1.7mm diameter FORESTADENT company

Intervention Type DEVICE

Standard Frog molar distalizing appliance

Nance buttons attached to first premolars band

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Skeletal Frog Conventional Frog

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Riyadh Abdullah Iskander

PhD candidate, orthodontic department

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

999

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.