Maxillary RetrusionNCT05446714
Evaluation of the Effect of Three Types of Rapid Maxillary Expanders (Conventional, Hybrid and MSE)
A study testing CH 4 band, HH 2 bands and MSE 2 bands and 4 in people with Maxillary Retrusion and Nasal Airway Obstruction, run by Al-Azhar University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Maxillary Retrusion, Nasal Airway Obstruction
- What is being tested?
- CH 4 band, HH 2 bands and MSE 2 bands and 4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2022to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- previous treatment
- syndromes
- cleft lip and palate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Three Types of Rapid Maxillary Expanders (Conventional, Hybrid, And MSE) on Maxilla in Adolescent A Randomized Clinical Trial - CBCT Study
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).
Read the 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).
- Conditions
- Maxillary Retrusion, Nasal Airway Obstruction
- Being tested
- CH 4 band, HH 2 bands, MSE 2 bands and 4
- Medical subject headings
- Retrognathia, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CH 4 bandDevice
Also called rapid palatal expansion, Orthodontic rapid maxillary expansion
expansion of maxilla and observation improvement of the air way
HH 2 bandsDevice
expansion of maxilla and observation improvement of the air way
MSE 2 bands and 4Device
expansion of maxilla and observation improvement of the air way
| Study group | Role | What they receive |
|---|---|---|
| conventional hyrax | Active comparator | CH 4 BANDS for expansion of maxilla and observation improvement of the air way Receives: Device: CH 4 band |
| Hybrid hyrax | Active comparator | HH 2 BANDS for expansion of maxilla and observation improvement of the air way Receives: 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 Receives: Device: MSE 2 bands and 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Molar Inclination
amount of degree of Molar inclination change before and after maxillary expansion which measured from the long axis of upper first molar to palatal plane by CBCT Evaluation
Measured: 6 months
Maxillary Width
amount of maxillary width changes by CBCT Evaluation
Measured: 6 months
Temporomandibular Joint
CBCT Evaluation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start30 Apr 2022
- Primary completion19 Nov 2023
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maxillary RetrusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Mohamed Abdelrhman Shendy Abdelrhman, Al-Azhar University
- Investigators
- Shendy, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446714
- Sponsor's protocol ID
- 775/220
- Other IDs
- Ahmed, lecturer
- Status last verified
- Apr 2025
- First submitted
- 20 Jun 2022
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CBCT Measurements
Publications
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.
PubMed 19852655Lagravere 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.
PubMed 16448254
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Three Types of Rapid Maxillary Expanders (Conventional, Hybrid, And MSE) on Maxilla in Adolescent A Randomized Clinical Trial - CBCT Study
- ClinicalTrials.gov ID
- NCT05446714
- Acronym / sponsor ID
- 775/220
- Conditions
- Maxillary Retrusion, Nasal Airway Obstruction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 19 Nov 2023 (actual)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Posted 25 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional hyrax | Active comparator | Device: CH 4 bandCH 4 BANDS for expansion of maxilla and observation improvement of the air way |
| Hybrid hyrax | Active comparator | Device: HH 2 bandsHH 2 BANDS for expansion of maxilla and observation improvement of the air way |
| Maxillary skeletal expander | Active comparator | Device: MSE 2 bands and 4MSE 2 BANDS AND 4 for expansion of maxilla and observation improvement of the air way |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- previous treatment
- syndromes
- cleft lip and palate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CH 4 bandAlso: rapid palatal expansion, Orthodontic rapid maxillary expansionexpansion of maxilla and observation improvement of the air way | Device | conventional hyrax |
| HH 2 bandsexpansion of maxilla and observation improvement of the air way | Device | Hybrid hyrax |
| MSE 2 bands and 4expansion of maxilla and observation improvement of the air way | Device | Maxillary skeletal expander |
Primary outcome
Molar Distance:
Time frame: 6 months
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
3 secondary outcomes
Molar Inclination
Time frame: 6 months
Maxillary Width
Time frame: 6 months
Temporomandibular Joint
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19852655Gracco 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 publication: PubMed 16448254Lagravere 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.
- Individual participant dataSharing planned: Yes. CBCT Measurements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shendy principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CH 4 band, HH 2 bands and MSE 2 bands and 4 in people with Maxillary Retrusion and Nasal Airway Obstruction, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molar Distance: (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05446714, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.