Maxillary Transverse DeficiencyNCT06502041
MARPE Effect With/Without MOP in Non-growing Patients
A study testing MARPE with MOP and MARPE without MOP in people with Maxillary Transverse Deficiency, run by Mansoura University at 1 site in Egypt.
Trial summary
This study compares the effect of MARPE (mini-implant assisted rapid palatal expansion) versus MARPE+ MOP (Micro-osteo-perforation) on nasal airway and maxillary transverse deficiency in non-growing patients. Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Transverse Deficiency
- What is being tested?
- MARPE with MOP and MARPE without MOP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2022to 3 Jul 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 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The age ranges from 20-25 years.
- Post pubertal adolescent
- Skeletal transverse deficiency with unilateral or bilateral cross-bite
- Extraction is not indicated in the lower arch.
- Upper permanent dentition is erupted up to the second molars.
- Average facial vertical growth pattern.
- Space deficiency in the upper arch is less than 8 mm
Who cannot join
- Diseases and medications those are likely to affect bone biology.
- Evidence of root resorption.
- Poor oral hygiene.
- Previous orthodontic treatment.
- Evidence of bone loss.
- Active periodontal disease.
- Craniofacial congenital anomalies, such as cleft lip and palate.
- 7. Pregnant females. 8. Presence of oral habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial Comparing MARPE Effect With/Without MOP in Management of Skeletal Transverse Deficiency in Non-growing Patients
This study compares the effect of MARPE (mini-implant assisted rapid palatal expansion) versus MARPE+ MOP (Micro-osteo-perforation) on nasal airway and maxillary transverse deficiency in non-growing patients.
Read the detailed description
All participants with skeletal transverse deficiency with unilateral or bilateral cross-bite aging 20-25 years were treated by expansion of maxillary arch as a first phase of treatment with one expander screw which was anchored to mini-implants placed in the palatal region (Mini-implant assissted rapid palatal expansion; MARPE). The patient's bone support in the anterior area of the palate was examined on CBCT. Micro-osteoperforation (MOP) was done along of medial palatine raphe in the intervention group. Control-group is the same of the intervention group but without micro-osteo-perforations.
- Conditions
- Maxillary Transverse Deficiency
- Being tested
- MARPE with MOP, MARPE without MOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARPE with MOPProcedure or surgery
mini-screw assisted rapid palatal expansion with micro-osteoperforation
MARPE without MOPProcedure or surgery
mini-screw assisted rapid palatal expansion without micro-osteoperforation
| Study group | Role | What they receive |
|---|---|---|
| MARPE with MOP | Experimental | Not described Receives: Procedure: MARPE with MOP |
| MARPE without MOP | Active comparator | Not described Receives: Procedure: MARPE without MOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days till diastema appearance
(days)
Measured: about 1 month
Amount of skeletal expansion
(mm)
Measured: about 1 month
Pain experience during activation of expander by visual analogue scale ( VAS)
VAS: 0 ( no pain), 10 (unbearable pain)
Measured: about 1 months
Skeletal, Dental & Nasal readings
from CBCT and scanned models measured in degrees \& mm
Measured: measured before treatment and after 6 month of treatment
Stability of correction of transverse deficiency
by measuring the same CBCT transverse reading and by superimposition of the scaneed models at the end of the research
Measured: about 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start5 Sep 2022
- Primary completion3 Jan 2024
- Study completion3 Jul 2024
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 Transverse DeficiencyStudies 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
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Motaz Elshehaby, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502041
- Sponsor's protocol ID
- A05020822
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the published results
Publications
Elshehaby M, Albelasy NF, Elbialy MA, Hafez AM, Abdelnaby YL. Evaluation of pain intensity and airway changes in non-growing patients treated by MARPE with and without micro-osteoperforation: a randomized clinical trial. BMC Oral Health. 2024 Nov 20;24(1):1411. doi: 10.1186/s12903-024-05196-4.
PubMed 39563319
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing MARPE Effect With/Without MOP in Management of Skeletal Transverse Deficiency in Non-growing Patients
- ClinicalTrials.gov ID
- NCT06502041
- Acronym / sponsor ID
- A05020822
- Conditions
- Maxillary Transverse Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 15 Jul 2024 (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.
This study compares the effect of MARPE (mini-implant assisted rapid palatal expansion) versus MARPE+ MOP (Micro-osteo-perforation) on nasal airway and maxillary transverse deficiency in non-growing patients.
Detailed description
All participants with skeletal transverse deficiency with unilateral or bilateral cross-bite aging 20-25 years were treated by expansion of maxillary arch as a first phase of treatment with one expander screw which was anchored to mini-implants placed in the palatal region (Mini-implant assissted rapid palatal expansion; MARPE). The patient's bone support in the anterior area of the palate was examined on CBCT. Micro-osteoperforation (MOP) was done along of medial palatine raphe in the intervention group. Control-group is the same of the intervention group but without micro-osteo-perforations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MARPE with MOP | Experimental | Procedure: MARPE with MOP |
| MARPE without MOP | Active comparator | Procedure: MARPE without MOP |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The age ranges from 20-25 years.
- Post pubertal adolescent
- Skeletal transverse deficiency with unilateral or bilateral cross-bite
- Extraction is not indicated in the lower arch.
- Upper permanent dentition is erupted up to the second molars.
Key exclusion criteria (8 listed)
- Diseases and medications those are likely to affect bone biology.
- Evidence of root resorption.
- Poor oral hygiene.
- Previous orthodontic treatment.
- Evidence of bone loss.
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 |
|---|---|---|
| MARPE with MOPmini-screw assisted rapid palatal expansion with micro-osteoperforation | Procedure or surgery | MARPE with MOP |
| MARPE without MOPmini-screw assisted rapid palatal expansion without micro-osteoperforation | Procedure or surgery | MARPE without MOP |
Primary outcome
Number of days till diastema appearance
Time frame: about 1 month
(days)
Amount of skeletal expansion
Time frame: about 1 month
(mm)
Pain experience during activation of expander by visual analogue scale ( VAS)
Time frame: about 1 months
VAS: 0 ( no pain), 10 (unbearable pain)
Skeletal, Dental & Nasal readings
Time frame: measured before treatment and after 6 month of treatment
from CBCT and scanned models measured in degrees \& mm
Stability of correction of transverse deficiency
Time frame: about 6 months
by measuring the same CBCT transverse reading and by superimposition of the scaneed models at the end of the research
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 15 Jul 2024.
- Derived from this study: PubMed 39563319Elshehaby M, Albelasy NF, Elbialy MA, Hafez AM, Abdelnaby YL. Evaluation of pain intensity and airway changes in non-growing patients treated by MARPE with and without micro-osteoperforation: a randomized clinical trial. BMC Oral Health. 2024 Nov 20;24(1):1411. doi: 10.1186/s12903-024-05196-4.
- Individual participant dataSharing planned: No. the published results
Related trials for Maxillary Transverse Deficiency
Not yet recruitingObservational study
Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
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Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
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Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
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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.
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 MARPE with MOP and MARPE without MOP in people with Maxillary Transverse Deficiency, run by Mansoura 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 8 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 15 Jul 2024. 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?
Number of days till diastema appearance (time frame: about 1 month). The study lists 5 primary outcomes in all. 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 NCT06502041, 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 15 Jul 2024.