NCT05446714

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 25, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

June 20, 2022

Results QC Date

February 14, 2024

Last Update Submit

April 23, 2025

Conditions

Maxillary RetrusionNasal Airway Obstruction

Outcome Measures

Primary Outcomes (1)

  • Molar Distance:

    distance in milimeter from mesiolingual cusp of upper first molar in one side to mesiolingual cusp of upper first molar in the other CBCT Measurements software

    6 months

Secondary Outcomes (3)

  • Molar Inclination

    6 months

  • Maxillary Width

    6 months

  • Temporomandibular Joint

    6 months

Study Arms (3)

conventional hyrax

ACTIVE COMPARATOR

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

Device: CH 4 band

Hybrid hyrax

ACTIVE COMPARATOR

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

Device: HH 2 bands

Maxillary skeletal expander

ACTIVE COMPARATOR

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

Device: MSE 2 bands and 4

Interventions

CH 4 bandDEVICE

expansion of maxilla and observation improvement of the air way

Also known as: rapid palatal expansion, Orthodontic rapid maxillary expansion
conventional hyrax
HH 2 bandsDEVICE

expansion of maxilla and observation improvement of the air way

Hybrid hyrax
MSE 2 bands and 4DEVICE

expansion of maxilla and observation improvement of the air way

Maxillary skeletal expander

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • previous treatment
  • syndromes
  • cleft lip and palate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo

Cairo, Egypt

Location

Related 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.

    PMID: 19852655BACKGROUND

  • 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.

    PMID: 16448254RESULT

MeSH Terms

Conditions

RetrognathiaNasal Obstruction

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMandibular DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Results Point of Contact

Title
dr. mohamed shendy
Organization
al-azhar university
Shendy_ortho@azhar.edu.eg
01223303833

Study Officials

  • Shendy

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

June 20, 2022

First Posted

July 7, 2022

Study Start

April 30, 2022

Primary Completion

November 19, 2023

Study Completion

June 20, 2025

Last Updated

April 25, 2025

Results First Posted

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

CBCT Measurements

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
6 months
Access Criteria
Constricted maxilla

Locations

EG(1)