Posterior CrossbiteNCT05433038
Effects of Skeletally Anchored Maxillary Expander Via Two Approaches of Microosteoperforations
A study testing skeletally anchored maxillary expander in people with Posterior Crossbite, run by Al-Azhar University at 1 site in Egypt.
Trial summary
study will be directed to evaluate two approaches of microosteoperforations during skeletally anchored maxillary expansion Read more about this study
- Who is it for?
- Ages 18 to 22 years
- Conditions the study is for
- Posterior Crossbite
- What is being tested?
- skeletally anchored maxillary expander
- 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
- 20 May 2022to 1 Nov 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 22 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients should satisfy the following criteria:-
- An age range from 18-22.
- Transverse maxillary deficiency.
- Crossbite (unilateral or bilateral)
- No previous orthodontic treatment.
- Good oral and general health.
- No systemic disease/ medication that could interfere with OTM.
Who cannot join
- History of systemic and medical illness.
- History of extraction of permanent teeth.
- Previos orthodontic treatment.
- Poor oral hygiene or periodontally compromised patient.
- Patient with craniofacial anomaly or previous history of trauma,bruxism or parafunctions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dento-skeletal Effects of Skeletally Anchored Maxillary Expander Assisted With Two Approaches of Microosteoperforations
study will be directed to evaluate two approaches of microosteoperforations during skeletally anchored maxillary expansion
Read the detailed description
Dento-skeletal effects of skeletally anchored maxillary expander assisted with two approaches of microosteoperforations.
- Conditions
- Posterior Crossbite
- Being tested
- skeletally anchored maxillary expander
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skeletally anchored maxillary expanderDevice
Also called mini implant assisted rapid palatine expander
used from day one and activated two times per day for two weeks
| Study group | Role | What they receive |
|---|---|---|
| skeletal expander with microosteoperforation in mid palatine | Active comparator | group1.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture Receives: Device: skeletally anchored maxillary expander |
| skeletal expander with microosteoperforation in mid palatine and buccally | Active comparator | group2.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture and buccally Receives: Device: skeletally anchored maxillary expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
skeletally transverse measurement
using cone beam computed tomography
Measured: from start of treatment until study completion an average of 1 year
dentolinear measurement
using cone beam computed tomography
Measured: from start of treatment until study completion an average of 1 year
dentoangular measurement
using cone beam computed tomography
Measured: from start of treatment until study completion an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start20 May 2022
- Primary completion20 Apr 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior CrossbiteStudies 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
- 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, Amgad Ragab Alawady kaoah, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433038
- Sponsor's protocol ID
- 798/1901
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dento-skeletal Effects of Skeletally Anchored Maxillary Expander Assisted With Two Approaches of Microosteoperforations
- ClinicalTrials.gov ID
- NCT05433038
- Acronym / sponsor ID
- 798/1901
- Conditions
- Posterior Crossbite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 27 Jun 2022 (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.
study will be directed to evaluate two approaches of microosteoperforations during skeletally anchored maxillary expansion
Detailed description
Dento-skeletal effects of skeletally anchored maxillary expander assisted with two approaches of microosteoperforations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| skeletal expander with microosteoperforation in mid palatine | Active comparator | Device: skeletally anchored maxillary expandergroup1.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture |
| skeletal expander with microosteoperforation in mid palatine and buccally | Active comparator | Device: skeletally anchored maxillary expandergroup2.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture and buccally |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- All patients should satisfy the following criteria:-
Key exclusion criteria (5 listed)
- History of systemic and medical illness.
- History of extraction of permanent teeth.
- Previos orthodontic treatment.
- Poor oral hygiene or periodontally compromised patient.
- Patient with craniofacial anomaly or previous history of trauma,bruxism or parafunctions.
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 |
|---|---|---|
| skeletally anchored maxillary expanderAlso: mini implant assisted rapid palatine expanderused from day one and activated two times per day for two weeks | Device | skeletal expander with microosteoperforation in mid palatine, skeletal expander with microosteoperforation in mid palatine and buccally |
Primary outcome
skeletally transverse measurement
Time frame: from start of treatment until study completion an average of 1 year
using cone beam computed tomography
dentolinear measurement
Time frame: from start of treatment until study completion an average of 1 year
using cone beam computed tomography
dentoangular measurement
Time frame: from start of treatment until study completion an average of 1 year
using cone beam computed tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
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Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
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Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skeletally anchored maxillary expander in people with Posterior Crossbite, 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 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 27 Jun 2022. 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?
skeletally transverse measurement (time frame: from start of treatment until study completion an average of 1 year). The study lists 3 primary outcomes in all. 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 27 Jun 2022.