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

NCT ID: NCT05446714

Last Updated: 2025-04-25

Study Results

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2025-06-20

Brief Summary

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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

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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).

Conditions

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Maxillary Retrusion Nasal Airway Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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conventional hyrax

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

Group Type ACTIVE_COMPARATOR

CH 4 band

Intervention Type DEVICE

expansion of maxilla and observation improvement of the air way

Hybrid hyrax

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

Group Type ACTIVE_COMPARATOR

HH 2 bands

Intervention Type DEVICE

expansion of maxilla and observation improvement of the air way

Maxillary skeletal expander

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

Group Type ACTIVE_COMPARATOR

MSE 2 bands and 4

Intervention Type DEVICE

expansion of maxilla and observation improvement of the air way

Interventions

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CH 4 band

expansion of maxilla and observation improvement of the air way

Intervention Type DEVICE

HH 2 bands

expansion of maxilla and observation improvement of the air way

Intervention Type DEVICE

MSE 2 bands and 4

expansion of maxilla and observation improvement of the air way

Intervention Type DEVICE

Other Intervention Names

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rapid palatal expansion Orthodontic rapid maxillary expansion

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Health Organization

OTHER

Sponsor Role collaborator

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Abdelrhman Shendy Abdelrhman

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shendy

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

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Cairo

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 19852655 (View on PubMed)

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.

Reference Type RESULT
PMID: 16448254 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Ahmed

Identifier Type: OTHER

Identifier Source: secondary_id

lecturer

Identifier Type: REGISTRY

Identifier Source: secondary_id

775/220

Identifier Type: -

Identifier Source: org_study_id

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