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MARPE-Associated Changes in Sleep and Airway

Evaluation of Changes in Upper Airway Dimensions and Subjective Sleep Quality Following Miniscrew-Assisted Rapid Palatal Expansion: A Questionnaire-Based Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07031349
Enrollment
40
Registered
2025-06-22
Start date
2025-05-30
Completion date
2025-09-05
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rapid Maxillary Expansion

Keywords

MARPE, STOP-BANG, PSQI

Brief 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). 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.

Interventions

DEVICEMARPE

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

Sponsors

Konya Necmettin Erbakan Üniversitesi
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in obstructive sleep apnea (OSA) risk as measured by the teen-STOP-BANG questionnaire3 monthThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSeda Sağoğlu
ssagoglu@gmail.com+905354121271
Backup ContactKazım K YILDIZ

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026