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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Nasal Airway Obstruction; Maxillary Retrusion
• Intervention / Treatment: Device: CH 4 band; Device: HH 2 bands; Device: MSE 2 bands and 4

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional hyrax; CH 4 BANDS for expansion of maxilla and observation improvement of the air way	Device: CH 4 band; expansion of maxilla and observation improvement of the air way; Other Names: rapid palatal expansion; Orthodontic rapid maxillary expansion
Active Comparator: Hybrid hyrax; HH 2 BANDS for expansion of maxilla and observation improvement of the air way	Device: HH 2 bands; expansion of maxilla and observation improvement of the air way
Active Comparator: Maxillary skeletal expander; MSE 2 BANDS AND 4 for expansion of maxilla and observation improvement of the air way	Device: MSE 2 bands and 4; expansion of maxilla and observation improvement of the air way

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molar Distance:	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molar Inclination	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	6 months
Maxillary Width	amount of maxillary width changes by CBCT Evaluation	6 months
Temporomandibular Joint	CBCT Evaluation	6 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Collaborators: World Health Organization
• Investigators: Principal Investigator: Shendy, Al-Azhar University

Publications and helpful links

General Publications

• Gracco A, Malaguti A, Lombardo L, Mazzoli A, Raffaeli R. Palatal volume following rapid maxillary expansion in mixed dentition. Angle Orthod. 2010 Jan;80(1):153-9. doi: 10.2319/010407-7.1.
• Lagravere MO, Major PW, Flores-Mir C. Long-term skeletal changes with rapid maxillary expansion: a systematic review. Angle Orthod. 2005 Nov;75(6):1046-52. doi: 10.1043/0003-3219(2005)75[1046:LSCWRM]2.0.CO;2.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2022
• Primary Completion (Actual): November 19, 2023
• Study Completion (Estimated): June 20, 2025

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Jaw Diseases; Respiratory Tract Diseases; Respiration Disorders; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Nose Diseases; Otorhinolaryngologic Diseases; Respiratory Insufficiency; Retrognathia; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: 775/220; Ahmed (Other Identifier: AlAzhar); lecturer (Registry Identifier: Ahmed Abo Elnour)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: CBCT Measurements
• IPD Sharing Time Frame: 6 months
• IPD Sharing Access Criteria: Constricted maxilla
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No