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

Nasal Airway Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05446714
• Other study ID #: 775/220
• Secondary ID: Ahmedlecturer
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: August 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 20, 2023
• Est. primary completion date: November 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Nasal Airway Obstruction
• Nasal Obstruction
• Retrognathia

Intervention

Device:
• CH 4 band
expansion of maxilla and observation improvement of the air way
• HH 2 bands
expansion of maxilla and observation improvement of the air way
• MSE 2 bands and 4
expansion of maxilla and observation improvement of the air way

Locations

Country	Name	City	State
Egypt	Cairo	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Al-Azhar University	World Health Organization

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maxillary sinus and Pharyngeal airway morphometric dimension changes	CBCT Measurements software	6 months
Secondary	Molar inclination	amount of Molar inclination by CBCT Evaluation	6 months
Secondary	maxillary width	amount of maxillary width changes by CBCT Evaluation	6 months
Secondary	temporomandibular joint	CBCT Evaluation	6 months