Transverse Maxillary DeficiencyNCT06130748
Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood
A study testing Hybrid Hyrax in people with Transverse Maxillary Deficiency, run by Cairo University at 1 site in Egypt.
Trial summary
The study aiming at evaluation of the Skeletal and Dento-alveolar expansion in adult patents using Two Mini-screws Supported Hyrax compared with untreated control group. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Transverse Maxillary Deficiency
- What is being tested?
- Hybrid Hyrax
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2023to 2 Jun 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unilateral or bilateral Dental posterior cross-bite
- Skeletal Maxillary constriction
- Male and female patients.
- Chronological age (18-30 years).
- Mid-palatal suture maturation (Grade C,D ) according to F Angileri classification
- Good oral hygiene.
- No craniofacial anomalies or syndromes
Who cannot join
- Scissor-bite
- Orthodontically-treated
- functional cross bite due to premature occlusal contact
- patients with a syndrome
- cleft patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry, Cairo university
Cairo, Giza Governorate, 4240310
About this study
Official title: Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood: A Randomized Control Trial.
The study aiming at evaluation of the Skeletal and Dento-alveolar expansion in adult patents using Two Mini-screws Supported Hyrax compared with untreated control group.
Read the detailed description
Methodology:
- Basic orthodontic record will be taken.
- impression with bands on upper first molars will be taken.
- Two eyelets will be soldered to the body of the hyrax appliance (size 10, Dentaurum, Germany).
- CBCT will be taken while patient wearing 1 mm thickness vacuum on the lower arch to dis-occlude both arches.
- Delivery, check the retention and fitness of the appliance.
- Cementation of the appliance using band cement(compomer).
- Using 3M contra-angle driver, the screws (Tomas screw size 10, Dentaurum, Germany) will be loaded and inserted.
- Activation of the appliance by opening it two turns immediately, followed by two turns everyday till cross bite correction or appearance of midline diastema.
- Closure of the device, and leave the appliance in-situ for five months as a retention.
- Post-expansion CBCT will be taken and continue fixed orthodontic treatment. Outcome: skeletal and dento-alveolar expansion will be evaluated
- Conditions
- Transverse Maxillary Deficiency
- Being tested
- Hybrid Hyrax
- Keywords
- maxillary expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid HyraxDevice
Also called MARPE(miniscrews-assisted rapid palatal expander)
these patents will be treated using Two mini-screws supported hybrid hyrax
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Hyrax | Experimental | Device: Hybrid hyrax these patents will be treated using Two mini-screws supported hybrid hyrax
Other Names:
• MARPE(miniscrews-assisted rapid palatal expander) Receives: Device: Hybrid Hyrax |
| Untreated control group | No intervention | Ethically ,these patents will be treated at the end of the study using the same appliance used for the experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal maxillary expansion To compare the amount of skeletal expansion pre and post expansion
To compare the amount of skeletal expansion using linear and angular measurements and the expansion pattern of mid-palatal suture extracted from cone beam computed tomography pre and post expansion
Measured: the outcome will be assessed five months post-expansion
Secondary outcomes (1)
Dento-alaveolar expansion
To compare the amount of dento-alveolar expansion using linear and angular measurements extracted from cone beam computed tomography pre and post-expansion
Measured: the outcome will be assessed five months post-expansion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start2 Apr 2023
- Primary completion2 Dec 2023 (estimated)
- Study completion2 Jun 2024 (estimated)
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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 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
- abdullah mo ali al-thalabi, Msc candidate, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130748
- Sponsor's protocol ID
- 15623
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Mini-screws Supported Hyrax for Maxillary Expansion in Early Adulthood: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT06130748
- Acronym / sponsor ID
- 15623
- Conditions
- Transverse Maxillary Deficiency
- Keywords
- maxillary expansion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 2 Dec 2023 (estimated)
- Study completion
- 2 Jun 2024 (estimated)
- First posted
- 14 Nov 2023 (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.
The study aiming at evaluation of the Skeletal and Dento-alveolar expansion in adult patents using Two Mini-screws Supported Hyrax compared with untreated control group.
Detailed description
Methodology:
- Basic orthodontic record will be taken.
- impression with bands on upper first molars will be taken.
- Two eyelets will be soldered to the body of the hyrax appliance (size 10, Dentaurum, Germany).
- CBCT will be taken while patient wearing 1 mm thickness vacuum on the lower arch to dis-occlude both arches.
- Delivery, check the retention and fitness of the appliance.
- Cementation of the appliance using band cement(compomer).
- Using 3M contra-angle driver, the screws (Tomas screw size 10, Dentaurum, Germany) will be loaded and inserted.
- Activation of the appliance by opening it two turns immediately, followed by two turns everyday till cross bite correction or appearance of midline diastema.
- Closure of the device, and leave the appliance in-situ for five months as a retention.
- Post-expansion CBCT will be taken and continue fixed orthodontic treatment. Outcome: skeletal and dento-alveolar expansion will be evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Hyrax | Experimental | Device: Hybrid HyraxDevice: Hybrid hyrax these patents will be treated using Two mini-screws supported hybrid hyrax Other Names: • MARPE(miniscrews-assisted rapid palatal expander) |
| Untreated control group | No intervention | –Ethically ,these patents will be treated at the end of the study using the same appliance used for the experimental group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Unilateral or bilateral Dental posterior cross-bite
- Skeletal Maxillary constriction
- Male and female patients.
- Chronological age (18-30 years).
- Mid-palatal suture maturation (Grade C,D ) according to F Angileri classification
Key exclusion criteria (5 listed)
- Scissor-bite
- Orthodontically-treated
- functional cross bite due to premature occlusal contact
- patients with a syndrome
- cleft patients
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 |
|---|---|---|
| Hybrid HyraxAlso: MARPE(miniscrews-assisted rapid palatal expander)these patents will be treated using Two mini-screws supported hybrid hyrax | Device | Hybrid Hyrax |
Primary outcome
Skeletal maxillary expansion To compare the amount of skeletal expansion pre and post expansion
Time frame: the outcome will be assessed five months post-expansion
To compare the amount of skeletal expansion using linear and angular measurements and the expansion pattern of mid-palatal suture extracted from cone beam computed tomography pre and post expansion
1 secondary outcome
Dento-alaveolar expansion
Time frame: the outcome will be assessed five months post-expansion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Transverse Maxillary Deficiency
Not yet recruitingObservational study
Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
Maxillary Transverse Deficiency
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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.
abdullah mo ali al-thalabi, Msc candidate principal investigator
Cairo 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 Hybrid Hyrax in people with Transverse Maxillary Deficiency, 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. 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?
Results are not available in the source record.
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 maxillary expansion To compare the amount of skeletal expansion pre and post expansion (time frame: the outcome will be assessed five months post-expansion). 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 14 Nov 2023.