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Clinical Trials/NCT04229797
NCT04229797
Not Yet Recruiting
N/A

The Efficacy of Mandibular First Molar Distalization Using Extra Radicular Miniscrews in Class III Patients: A Randomized Clinical Trial

Cairo University1 site in 1 country20 target enrollmentDecember 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Class III Malocclusion
Sponsor
Cairo University
Enrollment
20
Locations
1
Primary Endpoint
Dental effect
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

A clinical study to test the capability of the mini-screws inserted in the Mandibular buccal shelf area as an anchorage unit to distalize mandibular first molar for correction of mild to moderate Class III cases. The second aim was to detect if there is a difference in the amount of distalization in the presence of unerupted mandibular third molars, using the same technique.

Detailed Description

Class III malocclusion in adults is one of the most complex malocclusions in clinical orthodontics. For adults, the ideal treatment option for Class III malocclusion is accomplished either by camouflage treatment in mild to moderate cases or orthognathic surgery in severe cases. Camouflage treatment for Class III malocclusion comprises three main techniques; Class III elastics, mandibular first molar distalization, or extraction of mandibular first premolars. Mandibular first molar distalization via the use of skeletal anchorage has the problem of increased failure rate of the inter-radicular temporary anchorage devices (TADs). Accordingly, a randomized clinical trial using extra radicular TADs in the Mandibular buccal shelf area was designed in the current research aiming to test the efficacy of such a technique in inducing mandibular molar distalization with decreased failure rate, and whether the presence of unerupted mandibular third molars will affect the distalization movement or not.

Registry
clinicaltrials.gov
Start Date
December 2024
End Date
March 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Khaled Makhlouf

Associate researcher NRC

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Class III dental incisal relation.
  • Dental canine and molar relation not more than half unit Class III.
  • Presence of unerupted mandibular third molars on both sides.
  • Skeletal Class I or mild Class III.
  • Full Permanent dentition.
  • Medically free subjects.

Exclusion Criteria

  • Patients with systemic diseases or neuromuscular disorders.
  • Retroclined lower incisors.
  • Sever skeletal dysplasia.
  • Patients with periodontal disease.

Outcomes

Primary Outcomes

Dental effect

Time Frame: 6 months

Amount of first mandibular molar distalization (mm) in the two groups, A cephalometric of pre and post distalization digital cephalograms will be traced, landmarks and reference lines will be determined; skeleto-dental and soft tissue measurements will be performed using Quick-Ceph program . Digital models of pre and post distalization will be superimposed and measured for dental changes using Anatomage program.

Secondary Outcomes

  • Skeletal and soft tissue effect(6 months)

Study Sites (1)

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