Transverse Maxillary DeficiencyRCTNCT06851728
Immediate Skeletal and Dento-alveolar Effects of Two and Four Mini-screw Supported Hyrax for Maxillary Expansion in Non-growing Patients
A study testing MARPE in people with Transverse Maxillary Deficiency and Posterior Crossbite, Upper Airway, run by Cairo University at 1 site in Egypt.
Trial summary
transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects, therefore ,recently A minis crews assisted rapid expansion is recently introduced to overcome hence complications Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Transverse Maxillary Deficiency, Posterior Crossbite, Upper Airway
- What is being tested?
- MARPE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2023to 4 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adults male or female aged from 18-30 years with skeletal Maxillary constriction
- unilateral or bilateral Dental posterior cross-bite
- mid-palatal suture maturation (Grade C, D) according to F Angileri classification
- good oral hygiene
Who cannot join
- no functional crossbite due to premature contacts
- no previous orthodontic treatment
- no buccal crossbite
- no craniofacial anomalies or syndromes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Skeletal and Dento-alveolar Effects of Two and Four Mini-screw Supported Hyrax for Maxillary Expansion in Non-growing Patients: A Randomized Controlled Clinical Trial
transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects, therefore ,recently A minis crews assisted rapid expansion is recently introduced to overcome hence complications
Read the detailed description
transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects such as buccal tipping, marginal bone loss, dento aloveolar expansion.
in such cases , surgically assisted rapid palatal expansion used to be the option of choice ,due to the invasiveness of the procedure and co-morbidity associated with it ,minis crews assisted rapid expansion is recently introduced to overcome the complications of both convectional and surgically assisted rapid palatal expansion
- Being tested
- MARPE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARPEDevice
treating patients with transverse maxillary deficiency using minis crews supported hybrid hyrax
| Study group | Role | What they receive |
|---|---|---|
| Group one | Experimental | two mini screws supported hyrax was used Receives: Device: MARPE |
| Group two | Experimental | four minis crews supported hyrax was used Receives: Device: MARPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal effects
To compare the amount of skeletal expansion using linear (mm)measurement extracted from cone beam computed tomography pre and post-expansion
Measured: the outcome will be assessed immediate post expansion (one month-tow month)
Secondary outcomes (2)
Dento-alveolar effects
To compare the amount of Dento-alveolar expansion using linear (mm) measurement extracted from cone beam computed tomography pre and post-expansion
Measured: 1-2 months
Dento-alveolar effects
To compare the amount of Dento-alveolar expansion using angular(degree) measurement extracted from cone beam computed tomography pre and post-expansion
Measured: 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start2 Feb 2023
- Primary completion2 Aug 2023
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transverse Maxillary DeficiencyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- two experimental groups ,two screw supported and four screw supported hyrax
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdullah mohammed ali al-thalabi, Cairo University
- Investigators
- fady hussein fahim, PhD, Study director, Associate proffnada Omer elzawahry, PhD, Study director, lecturerelzubair osman salih, MSc, Study director, MSc degree candidate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851728
- Sponsor's protocol ID
- 33624
- Acronym
- RCT
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Skeletal and Dento-alveolar Effects of Two and Four Mini-screw Supported Hyrax for Maxillary Expansion in Non-growing Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06851728
- Acronym / sponsor ID
- RCT / 33624
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects, therefore ,recently A minis crews assisted rapid expansion is recently introduced to overcome hence complications
Detailed description
transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects such as buccal tipping, marginal bone loss, dento aloveolar expansion.
in such cases , surgically assisted rapid palatal expansion used to be the option of choice ,due to the invasiveness of the procedure and co-morbidity associated with it ,minis crews assisted rapid expansion is recently introduced to overcome the complications of both convectional and surgically assisted rapid palatal expansion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two experimental groups ,two screw supported and four screw supported hyrax
| Arm | Type | Receives |
|---|---|---|
| Group one | Experimental | Device: MARPEtwo mini screws supported hyrax was used |
| Group two | Experimental | Device: MARPEfour minis crews supported hyrax was used |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- adults male or female aged from 18-30 years with skeletal Maxillary constriction
- unilateral or bilateral Dental posterior cross-bite
- mid-palatal suture maturation (Grade C, D) according to F Angileri classification
- good oral hygiene
Key exclusion criteria (4 listed)
- no functional crossbite due to premature contacts
- no previous orthodontic treatment
- no buccal crossbite
- no craniofacial anomalies or syndromes.
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 |
|---|---|---|
| MARPEtreating patients with transverse maxillary deficiency using minis crews supported hybrid hyrax | Device | Group one, Group two |
Primary outcome
Skeletal effects
Time frame: the outcome will be assessed immediate post expansion (one month-tow month)
To compare the amount of skeletal expansion using linear (mm)measurement extracted from cone beam computed tomography pre and post-expansion
2 secondary outcomes
Dento-alveolar effects
Time frame: 1-2 months
Dento-alveolar effects
Time frame: 1-2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: Yes
Related trials for Transverse Maxillary Deficiency
Not yet recruitingObservational study
Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
Maxillary Transverse Deficiency
Not yet recruiting
Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
Maxillary Transverse Deficiency
Not yet recruiting
Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
Maxillary Transverse Deficiency, Rapid Maxillary Expansion
Active, not recruiting
Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
Maxillary Constriction
Recruiting
Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients
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.
fady hussein fahim, PhD study director
Associate proff
nada Omer elzawahry, PhD study director
lecturer
elzubair osman salih, MSc study director
MSc degree candidate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MARPE in people with Transverse Maxillary Deficiency and Posterior Crossbite, Upper Airway, run by Cairo 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 28 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Skeletal effects (time frame: the outcome will be assessed immediate post expansion (one month-tow month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2025.