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NCT Number: NCT05446714

Evaluation of the Effect of Three Types of Rapid Maxillary Expanders (Conventional, Hybrid and MSE)

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Maxillary Retrusion Airway Obstruction Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Mandibular Diseases Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Nasal Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Retrognathia Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

CH 4 band

Device

expansion of maxilla and observation improvement of the air way

Other names: rapid palatal expansion, Orthodontic rapid maxillary expansion

HH 2 bands

Device

expansion of maxilla and observation improvement of the air way

MSE 2 bands and 4

Device

expansion of maxilla and observation improvement of the air way

Primary outcomes

  1. 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

  1. Molar Inclination

    Time frame: 6 months

    amount of degree of Molar inclination change before and after maxillary expansion which measured from the long axis of upper first molar to palatal plane by CBCT Evaluation

  2. Maxillary Width

    Time frame: 6 months

    amount of maxillary width changes by CBCT Evaluation

  3. Temporomandibular Joint

    Time frame: 6 months

    CBCT Evaluation

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Collaborators

  • World Health Organization

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Jul 7, 2022
Registry last updated
Apr 25, 2025

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.

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