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
Sponsored by
About this trial
This is an interventional treatment trial for Maxillary Retrusion
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
Sites / Locations
- Cairo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
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
No
Studies a U.S. FDA-regulated Device Product
No
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
No
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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