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

Primary Purpose

Maxillary Retrusion, Nasal Airway Obstruction

Status

Active

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

CH 4 band

HH 2 bands

MSE 2 bands and 4

About this trial

This is an interventional treatment trial for Maxillary Retrusion

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cairo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

conventional hyrax

Hybrid hyrax

Maxillary skeletal expander

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

maxillary sinus and Pharyngeal airway morphometric dimension changes

CBCT Measurements software

Secondary Outcome Measures

Molar inclination

amount of Molar inclination by CBCT Evaluation

maxillary width

amount of maxillary width changes by CBCT Evaluation

temporomandibular joint

CBCT Evaluation

Full Information

NCT ID

NCT05446714

First Posted

June 20, 2022

Last Updated

August 16, 2023

Sponsor

Al-Azhar University

Collaborators

World Health Organization

1. Study Identification

Unique Protocol Identification Number

NCT05446714

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 30, 2022 (Actual)

Primary Completion Date

November 25, 2023 (Anticipated)

Study Completion Date

December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

Collaborators

World Health Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Maxillary Retrusion, Nasal Airway Obstruction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

conventional hyrax

Arm Type

Active Comparator

Arm Description

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

Arm Title

Hybrid hyrax

Arm Type

Active Comparator

Arm Description

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

Arm Title

Maxillary skeletal expander

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

CH 4 band

Other Intervention Name(s)

rapid palatal expansion, Orthodontic rapid maxillary expansion

Intervention Description

expansion of maxilla and observation improvement of the air way

Intervention Type

Device

Intervention Name(s)

HH 2 bands

Intervention Description

expansion of maxilla and observation improvement of the air way

Intervention Type

Device

Intervention Name(s)

MSE 2 bands and 4

Intervention Description

expansion of maxilla and observation improvement of the air way

Primary Outcome Measure Information:

Title

maxillary sinus and Pharyngeal airway morphometric dimension changes

Description

CBCT Measurements software

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Molar inclination

Description

amount of Molar inclination by CBCT Evaluation

Time Frame

6 months

Title

maxillary width

Description

amount of maxillary width changes by CBCT Evaluation

Time Frame

6 months

Title

temporomandibular joint

Description

CBCT Evaluation

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shendy

Organizational Affiliation

ALAZHAR UNIVERSITY

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cairo

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

CBCT Measurements

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

Constricted maxilla

Citations:

PubMed Identifier

19852655

Citation

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.

Results Reference

background

PubMed Identifier

16448254

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.

Results Reference

result

Learn more about this trial

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

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