Maxillary ExpansionNCT06059807
Root Resorption After Maxillary Expansion
A study testing maxillary expansion in people with Maxillary Expansion, run by Al-Azhar University.
Trial summary
The aim of this study will to evaluate the root resorption after RME by hyrax and hybrid hyrax appliances by using of cone beam computed tomography . Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Expansion
- What is being tested?
- maxillary expansion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to Feb 2025
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- skeletal maxillary transvers deficiency
- unilateral or bilateral posterior crossbite
- negative buccal corridor
- patient with good oral hygiene
- patient with no previous orthodontic treatment
- no systemic disease
Who cannot join
- craniofacial congenital anomalies
- a history of periodontal disease
- incomplete treatment records
Trial locations and contacts
No sites are listed yet.
mostafa mohamed dowaba, PhD contact
About this study
Official title: A Cone-Beam Computed Tomography Evaluation of Root Resorption After Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances (Expanders)
The aim of this study will to evaluate the root resorption after RME by hyrax and hybrid hyrax appliances by using of cone beam computed tomography .
- Conditions
- Maxillary Expansion
- Being tested
- maxillary expansion
- Keywords
- expanders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary expansionDevice
Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances
| Study group | Role | What they receive |
|---|---|---|
| hyrax group | Experimental | Not described Receives: Device: maxillary expansion |
| hybrid hyrax group | Experimental | Not described Receives: Device: maxillary expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in root resorption after maxillary expansion
A Cone-Beam Computed Tomography Evaluation of Root Resorption After Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances
Measured: 12 weeks following end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Jan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary ExpansionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Taher Mohamed Abo Ghalia, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059807
- Sponsor's protocol ID
- expanders
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miranda F, Cunha Bastos JCD, Magno Dos Santos A, Janson G, Pereira Lauris JR, Garib D. Dentoskeletal comparison of miniscrew-anchored maxillary protraction with hybrid and conventional hyrax expanders: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2021 Dec;160(6):774-783. doi: 10.1016/j.ajodo.2021.02.017. Epub 2021 Sep 9.
PubMed 34509329
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cone-Beam Computed Tomography Evaluation of Root Resorption After Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances (Expanders)
- ClinicalTrials.gov ID
- NCT06059807
- Acronym / sponsor ID
- expanders
- Conditions
- Maxillary Expansion
- Keywords
- expanders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 29 Sep 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 aim of this study will to evaluate the root resorption after RME by hyrax and hybrid hyrax appliances by using of cone beam computed tomography .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyrax group | Experimental | Device: maxillary expansion |
| hybrid hyrax group | Experimental | Device: maxillary expansion |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- skeletal maxillary transvers deficiency
- unilateral or bilateral posterior crossbite
- negative buccal corridor
- patient with good oral hygiene
- patient with no previous orthodontic treatment
Key exclusion criteria (3 listed)
- craniofacial congenital anomalies
- a history of periodontal disease
- incomplete treatment records
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 |
|---|---|---|
| maxillary expansionMaxillary Expansion Using Hyrax and Hybrid Hyrax Appliances | Device | hybrid hyrax group, hyrax group |
Primary outcome
Change in root resorption after maxillary expansion
Time frame: 12 weeks following end of treatment
A Cone-Beam Computed Tomography Evaluation of Root Resorption After Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Results publication: PubMed 34509329Miranda F, Cunha Bastos JCD, Magno Dos Santos A, Janson G, Pereira Lauris JR, Garib D. Dentoskeletal comparison of miniscrew-anchored maxillary protraction with hybrid and conventional hyrax expanders: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2021 Dec;160(6):774-783. doi: 10.1016/j.ajodo.2021.02.017. Epub 2021 Sep 9.
- Related InfoLink provided by the sponsor.
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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.
mostafa mohamed dowaba, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing maxillary expansion in people with Maxillary Expansion, run by Al-Azhar University.
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 6 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact mohamed taher aboghalia, master (01063534515, mohamedtaher606@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in root resorption after maxillary expansion (time frame: 12 weeks following end of treatment). 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 NCT06059807, which also lists 1 linked publication.
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 29 Sep 2023; AzTrials last refreshed its copy on 27 Oct 2026.