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Clinical Trials/NCT05446714
NCT05446714Active, not recruitingNot Applicable

Evaluation of Three Types of Rapid Maxillary Expanders (Conventional, Hybrid, And MSE) on Maxilla in Adolescent A Randomized Clinical Trial - CBCT Study

Al-Azhar University1 site in 1 country54 target enrollmentStarted: April 30, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
54
Locations
1
Primary Endpoint
Molar Distance:

Study Overview

Brief Summary

Aim of the study: To compare radiographically the morphometric changes in the nasal airway after using three types of rapid maxillary expansion (RME) conventional hyrax (CH), hybrid hyrax (HH) and maxillary skeletal expander (MSE) using cone beam computed tomography (CBCT).

Detailed Description

Abstract Aim of the study: To compare radiographically the morphometric changes in the nasal airway after using three types of rapid maxillary expansion (RME) conventional hyrax (CH), hybrid hyrax (HH) and maxillary skeletal expander (MSE) using cone beam computed tomography (CBCT).

Material and Methods

A total sample of thirty CBCT of patients presented with constricted maxilla with mean age of 14±3Y was randomized in to three groups. Group 1 CH, group 2 HH and group 3 MSE.

CBCT records were taken before(T1) and after six months (T2) of RME; the Airway was segmented and quantified using software (version 5.3.4.39USA).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
11 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients suffering maxillary collapse with a skeletal background
  • •Patients with unilateral or bilateral posterior crossbite.
  • •Patients with reduced or average anterior face height.
  • •Patients with no periodontal disease.
  • •Patients with good oral hygiene and general health.
  • •No systemic diseases that may affect bone quality or interfere with orthodontic treatment.
  • •Patients with erupted maxillary permanent first molars and premolars.
  • •Patients with no previous orthodontic treatment.

Exclusion Criteria

  • •previous treatment
  • •syndromes
  • •cleft lip and palate

Arms & Interventions

conventional hyrax

Active Comparator

CH 4 BANDS for expansion of maxilla and observation improvement of the air way

Intervention: CH 4 band (Device)

Hybrid hyrax

Active Comparator

HH 2 BANDS for expansion of maxilla and observation improvement of the air way

Intervention: HH 2 bands (Device)

Maxillary skeletal expander

Active Comparator

MSE 2 BANDS AND 4 for expansion of maxilla and observation improvement of the air way

Intervention: MSE 2 bands and 4 (Device)

Outcomes

Primary Outcomes

Molar Distance:

Time Frame: 6 months

distance in milimeter from mesiolingual cusp of upper first molar in one side to mesiolingual cusp of upper first molar in the other CBCT Measurements software

Secondary Outcomes

  • Molar Inclination(6 months)
  • Maxillary Width(6 months)
  • Temporomandibular Joint(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Abdelrhman Shendy Abdelrhman

Clinical professor

Al-Azhar University

Study Sites (1)

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