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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
First received
Last updated
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
Health authority
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

Study Design


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
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