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Distalization by Miniscrew (AU)

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ClinicalTrials.gov Identifier: NCT02427282
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : May 4, 2015
Sponsor:
Information provided by (Responsible Party):
Riyadh Abdullah Iskander, Ain Shams University

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

Condition or disease Intervention/treatment Phase
Distalization by Miniscrews Device: miniscrew-supported Frog molar distalizing appliance Device: Standard Frog molar distalizing appliance Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  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



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Layout table for eligibility information
Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Layout table for additonal information
Responsible Party: Riyadh Abdullah Iskander, PhD candidate, orthodontic department, Ain Shams University
ClinicalTrials.gov Identifier: NCT02427282    
Other Study ID Numbers: 999
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: May 4, 2015
Last Verified: April 2015