MARPE-Associated Changes in Sleep and Airway

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2025-09-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial on Oral Appliance Design for Improving Upper Airway Function and Sleep Quality

NCT03219034

Obstructive Sleep Apnea

COMPLETED NA

Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry

NCT01069068

Obstructive Sleep Apnea

COMPLETED

Validation of Functional Imaging as Predictive Tool for Outcome of Mandibular Replacement Appliance Therapy in Obstructive Sleep Apnea Hypopnea Syndrome Patients

NCT01524510

Obstructive Sleep Apnea Syndrome

UNKNOWN PHASE4

Effects of Two Different Amounts of Mandibular Protrusion in OSA Patients Using Mandibular Advancement Appliance

NCT04079153

Obstructive Sleep Apnea

UNKNOWN NA

OROPHARYNGEAL MYOFUNCTIONAL THERAPY IN OBSTRUCTIVE SLEEP APNEA

NCT06681974

Obstructive Sleep Apnea

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Rapid Maxillary Expansion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MARPE

Adult individuals treated with miniscrew-assisted rapid palatal expansion (MARPE)

Group Type OTHER

MARPE

Intervention Type DEVICE

Adult patients with maxillary constriction underwent maxillary expansion using a miniscrew-assisted rapid palatal expander (MARPE).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MARPE

Adult patients with maxillary constriction underwent maxillary expansion using a miniscrew-assisted rapid palatal expander (MARPE).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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°

Exclusion Criteria

Presence of systemic diseases Smoking Poor oral hygiene Lack of cooperation Mental retardation Obesity or nutritional disorders Macroglossia or mandibular retrognathia

Minimum Eligible Age

15 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes