Rapid Maxillary ExpansionNCT07031349
MARPE-Associated Changes in Sleep and Airway
A study testing MARPE in people with Rapid Maxillary Expansion, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
At the beginning of MARPE treatment (T1) and at the end of the 3-month consolidation phase (T2), patients will complete the teen-STOP-BANG questionnaire and the Pittsburgh Sleep Quality Index (PSQI) to assess the potential benefit of MARPE in reducing the risk of obstructive sleep apnea syndrome (OSAS). Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Rapid Maxillary Expansion
- What is being tested?
- MARPE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2025to 5 Sep 2025
- 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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Class I malocclusion Maxillary transverse deficiency Age between 15 and 18 years No systemic disease, cleft lip and palate, or speech disorders No history of prior orthodontic treatment Voluntary agreement to participate in the study Good oral hygiene ANB angle between 2° and 5°
Who cannot join
- Presence of systemic diseases Smoking Poor oral hygiene Lack of cooperation Mental retardation Obesity or nutritional disorders Macroglossia or mandibular retrognathia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kazım K YILDIZ contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Necmettin Erbakan University
Konya, Meram, 42090
Seda SAĞOĞLU, 05354121271, ssagoglu@gmail.com
Kazım Kaan K YILDIZ
About this study
Official title: Evaluation of Changes in Upper Airway Dimensions and Subjective Sleep Quality Following Miniscrew-Assisted Rapid Palatal Expansion: A Questionnaire-Based Study
At the beginning of MARPE treatment (T1) and at the end of the 3-month consolidation phase (T2), patients will complete the teen-STOP-BANG questionnaire and the Pittsburgh Sleep Quality Index (PSQI) to assess the potential benefit of MARPE in reducing the risk of obstructive sleep apnea syndrome (OSAS).
Additionally, changes in the upper airway will be evaluated using CBCT images obtained at T1 and T2.
Read the detailed description
In this clinical routine, approximately 30% of patients requiring rapid maxillary expansion (RME) are treated using the MARPE (Miniscrew-Assisted Rapid Palatal Expansion) method. To evaluate the potential benefits of MARPE in reducing the risk of obstructive sleep apnea syndrome (OSAS), patients are asked to complete the teen-STOP-BANG questionnaire and the Pittsburgh Sleep Quality Index (PSQI) at the beginning of treatment (T1) and at the end of the 3-month consolidation phase (T2).
To determine whether patients should undergo MARPE or conventional RME, midpalatal suture maturation is assessed as part of the routine protocol using cone-beam computed tomography (CBCT) images obtained before treatment initiation (T1). At the end of the MARPE screw activation period, a follow-up CBCT scan is routinely obtained to evaluate potential complications such as fractures in the zygomatic buttress region, alveolar bending, and the presence of dehiscence or fenestration on root surfaces. This scan also facilitates the controlled initiation of prolonged fixed orthodontic treatment.
Additionally, CBCT images obtained at T1 and T2 will be used to measure and compare the dimensions of the upper airway, including both oropharyngeal and nasopharyngeal regions.
- Conditions
- Rapid Maxillary Expansion
- Being tested
- MARPE
- Keywords
- MARPE, STOP-BANG, PSQI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARPEDevice
Adult patients with maxillary constriction underwent maxillary expansion using a miniscrew-assisted rapid palatal expander (MARPE).
| Study group | Role | What they receive |
|---|---|---|
| MARPE | Other | Adult individuals treated with miniscrew-assisted rapid palatal expansion (MARPE) Receives: Device: MARPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in obstructive sleep apnea (OSA) risk as measured by the teen-STOP-BANG questionnaire
The teen-STOP-BANG questionnaire will be used to assess changes in OSA risk following MARPE treatment. STOP-BANG scores range from 0 to 8; a score of at least 3 indicates that the patient is at risk of OSAHS, and a score of at least 5 indicates that the patient is at high risk of OSA.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start30 May 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion5 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Sağoğlu, Konya Necmettin Erbakan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031349
- Sponsor's protocol ID
- 2025/596
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Changes in Upper Airway Dimensions and Subjective Sleep Quality Following Miniscrew-Assisted Rapid Palatal Expansion: A Questionnaire-Based Study
- ClinicalTrials.gov ID
- NCT07031349
- Acronym / sponsor ID
- 2025/596
- Conditions
- Rapid Maxillary Expansion
- Keywords
- MARPE, STOP-BANG, PSQI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 5 Sep 2025 (estimated)
- First posted
- 22 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.
At the beginning of MARPE treatment (T1) and at the end of the 3-month consolidation phase (T2), patients will complete the teen-STOP-BANG questionnaire and the Pittsburgh Sleep Quality Index (PSQI) to assess the potential benefit of MARPE in reducing the risk of obstructive sleep apnea syndrome (OSAS).
Additionally, changes in the upper airway will be evaluated using CBCT images obtained at T1 and T2.
Detailed description
In this clinical routine, approximately 30% of patients requiring rapid maxillary expansion (RME) are treated using the MARPE (Miniscrew-Assisted Rapid Palatal Expansion) method. To evaluate the potential benefits of MARPE in reducing the risk of obstructive sleep apnea syndrome (OSAS), patients are asked to complete the teen-STOP-BANG questionnaire and the Pittsburgh Sleep Quality Index (PSQI) at the beginning of treatment (T1) and at the end of the 3-month consolidation phase (T2).
To determine whether patients should undergo MARPE or conventional RME, midpalatal suture maturation is assessed as part of the routine protocol using cone-beam computed tomography (CBCT) images obtained before treatment initiation (T1). At the end of the MARPE screw activation period, a follow-up CBCT scan is routinely obtained to evaluate potential complications such as fractures in the zygomatic buttress region, alveolar bending, and the presence of dehiscence or fenestration on root surfaces. This scan also facilitates the controlled initiation of prolonged fixed orthodontic treatment.
Additionally, CBCT images obtained at T1 and T2 will be used to measure and compare the dimensions of the upper airway, including both oropharyngeal and nasopharyngeal regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MARPE | Other | Device: MARPEAdult individuals treated with miniscrew-assisted rapid palatal expansion (MARPE) |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Class I malocclusion Maxillary transverse deficiency Age between 15 and 18 years No systemic disease, cleft lip and palate, or speech disorders No history of prior orthodontic treatment Voluntary agreement to participate in the study Good oral hygiene ANB angle between 2° and 5°
Key exclusion criteria (1 listed)
- Presence of systemic diseases Smoking Poor oral hygiene Lack of cooperation Mental retardation Obesity or nutritional disorders Macroglossia or mandibular retrognathia
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 |
|---|---|---|
| MARPEAdult patients with maxillary constriction underwent maxillary expansion using a miniscrew-assisted rapid palatal expander (MARPE). | Device | MARPE |
Primary outcome
Change in obstructive sleep apnea (OSA) risk as measured by the teen-STOP-BANG questionnaire
Time frame: 3 month
The teen-STOP-BANG questionnaire will be used to assess changes in OSA risk following MARPE treatment. STOP-BANG scores range from 0 to 8; a score of at least 3 indicates that the patient is at risk of OSAHS, and a score of at least 5 indicates that the patient is at high risk of OSA.
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 26 Jun 2025.
- Effect of surgically assisted rapid maxillary expansion on obstructive sleep apnea.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Rapid Maxillary Expansion
Not yet recruitingObservational study
Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
Maxillary Transverse Deficiency
Not yet recruiting
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.
Kazım K YILDIZ contact
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 in people with Rapid Maxillary Expansion, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Jun 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 Turkey (Türkiye). 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?
Contact Seda Sağoğlu (+905354121271, ssagoglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in obstructive sleep apnea (OSA) risk as measured by the teen-STOP-BANG questionnaire (time frame: 3 month). 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 26 Jun 2025.