Malocclusion, Class I/IIMIDPACNCT07038902
A Comparative Study Between Modified Miniscrew-Assisted Rapid Palatal Expander And Modified Rapid Palatal Expander in Molar Distalization Using Cone- Beam Computed Tomography
A study testing Group A: Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE) and Group B: Modified Rapid Palatal Expander (RPE) in people with Malocclusion, Class I/II and Crowding, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Comparative study between modified miniscrew-assisted rapid palatal expander and modified rapid palatal expander in molar distalization using CBCT. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Class I/II, Crowding, Maxillary First Molar Distalization
- What is being tested?
- Group A: Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE) and Group B: Modified Rapid Palatal Expander (RPE)
- 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
- 1 Nov 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Presence of permanent dentition
- Skeletal Class I
- Dental Class II molar relationship with moderate dental crowding
- Crowding >4mm
- Good oral hygiene
- Healthy periodontal condition
Who cannot join
- Presence of craniofacial syndromes or cleft palate
- History of previous orthodontic treatment
- Poor oral hygiene or active periodontal disease
- Contraindications to CBCT imaging (e.g., pregnancy, inability to remain still during the scan)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.
Asyut
About this study
Comparative study between modified miniscrew-assisted rapid palatal expander and modified rapid palatal expander in molar distalization using CBCT.
Read the detailed description
This research will be conducted as a prospective and randomized clinical trial.
- Being tested
- Group A: Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE), Group B: Modified Rapid Palatal Expander (RPE)
- Keywords
- Modified MARPE, Modified RPE, Molar Distalization, CBCT, Orthodontics
- Medical subject headings
- Malocclusion, Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE)Device
A skeletal anchorage-supported with miniscrews inserted into the palate using a self-drilling technique.
Group B: Modified Rapid Palatal Expander (RPE)Device
A tooth-borne anchorage focusing on molar distalization .
| Study group | Role | What they receive |
|---|---|---|
| Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE) | Experimental | Not described Receives: Device: Group A: Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE) |
| Modified Rapid Palatal Expander (RPE) | Experimental | Not described Receives: Device: Group B: Modified Rapid Palatal Expander (RPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Molar Distalization Measured by CBCT
Measured: Baseline (prior to initiation of molar distalization) At the end of the molar distalization phase (approximately 12 weeks post-treatment initiation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Nov 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Class I/IIStudies 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
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Abd ELhamid Ahmed Abu Elhagag, Al-Azhar University
- Investigators
- Mohammed Ahmed Salim, Professor, Study director, Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038902
- Sponsor's protocol ID
- MMARPE-MRPE-CBCT-DISTAL2025-AZ
- Other IDs
- MIDPAC-AZU-2025
- Acronym
- MIDPAC
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Modified Miniscrew-Assisted Rapid Palatal Expander And Modified Rapid Palatal Expander in Molar Distalization Using Cone- Beam Computed Tomography
- ClinicalTrials.gov ID
- NCT07038902
- Acronym / sponsor ID
- MIDPAC / MMARPE-MRPE-CBCT-DISTAL2025-AZ
- Keywords
- Modified MARPE, Modified RPE, Molar Distalization, CBCT, Orthodontics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 26 Jun 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.
Comparative study between modified miniscrew-assisted rapid palatal expander and modified rapid palatal expander in molar distalization using CBCT.
Detailed description
This research will be conducted as a prospective and randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE) | Experimental | Device: Group A: Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE) |
| Modified Rapid Palatal Expander (RPE) | Experimental | Device: Group B: Modified Rapid Palatal Expander (RPE) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of permanent dentition
- Skeletal Class I
- Dental Class II molar relationship with moderate dental crowding
- Crowding >4mm
- Good oral hygiene
Key exclusion criteria (4 listed)
- Presence of craniofacial syndromes or cleft palate
- History of previous orthodontic treatment
- Poor oral hygiene or active periodontal disease
- Contraindications to CBCT imaging (e.g., pregnancy, inability to remain still during the scan)
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 |
|---|---|---|
| Group A: Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE)A skeletal anchorage-supported with miniscrews inserted into the palate using a self-drilling technique. | Device | Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE) |
| Group B: Modified Rapid Palatal Expander (RPE)A tooth-borne anchorage focusing on molar distalization . | Device | Modified Rapid Palatal Expander (RPE) |
Primary outcome
Amount of Molar Distalization Measured by CBCT
Time frame: Baseline (prior to initiation of molar distalization) At the end of the molar distalization phase (approximately 12 weeks post-treatment initiation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Mohammed Ahmed Salim, Professor study director
Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE) and Group B: Modified Rapid Palatal Expander (RPE) in people with Malocclusion, Class I/II and Crowding, 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 6 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: under way, not looking for participants, as of the sponsor's last update on 24 Dec 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?
This study is still under way. Results are not available in the source record yet.
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?
Amount of Molar Distalization Measured by CBCT (time frame: Baseline (prior to initiation of molar distalization) At the end of the molar distalization phase (approximately 12 weeks post-treatment initiation).). 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 24 Dec 2025; AzTrials last refreshed its copy on 28 Oct 2026.