Skip to main content
OpenTrials
Completed

NCT Number: NCT02427282

Distalization by Miniscrew

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

miniscrew-supported Frog molar distalizing appliance

Device

miniscrew 10mm length and 1.7mm diameter FORESTADENT company

Other names: Skeletal Frog

Standard Frog molar distalizing appliance

Device

Nance buttons attached to first premolars band

Other names: Conventional Frog

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Miniscrew-supported Versus Standard Frog Molar Distalizing Appliances (Clinical Study)

Acronym: AU

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 28, 2015
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.