MARPE effects on sleep and the upper airway.
Evaluation of Changes in Upper Airway Dimensions and Subjective Sleep Quality Following Miniscrew-Assisted Rapid Palatal Expansion: A Questionnaire-Based Study
NA · Konya Necmettin Erbakan Üniversitesi · NCT07031349
This trial will test whether MARPE in 15–18-year-olds with a narrow upper jaw can lower sleep-apnea risk scores and increase upper airway size.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 15 Years to 18 Years |
| Sex | All |
| Sponsor | Konya Necmettin Erbakan Üniversitesi (other) |
| Locations | 1 site (Konya, Meram) |
| Trial ID | NCT07031349 on ClinicalTrials.gov |
What this trial studies
This interventional protocol enrolls 15–18-year-old patients with maxillary transverse deficiency who receive miniscrew-assisted rapid palatal expansion (MARPE) as part of routine care. Participants complete the teen-STOP-BANG and Pittsburgh Sleep Quality Index (PSQI) at treatment start (T1) and after a 3-month consolidation period (T2), while CBCT scans at both timepoints measure changes in oropharyngeal and nasopharyngeal airway dimensions. Midpalatal suture maturation on the initial CBCT guides selection of MARPE versus conventional RME, and a follow-up CBCT at the end of screw activation checks for complications such as zygomatic buttress fractures, alveolar bending, dehiscence, or fenestration. The protocol compares pre- and post-treatment airway metrics and sleep-related questionnaire scores to determine whether MARPE leads to measurable airway widening and improved sleep-related risk indicators.
Who should consider this trial
Good fit: Ideal candidates are cooperative 15–18-year-olds with Class I malocclusion and maxillary transverse deficiency, good oral hygiene, no prior orthodontic treatment, and no systemic disease, cleft lip/palate, or speech disorders.
Not a fit: Patients who are obese, smokers, have macroglossia or mandibular retrognathia, systemic disease, poor cooperation, or unfavourable suture maturation may be unlikely to benefit from MARPE in this protocol.
Why it matters
Potential benefit: If successful, MARPE could decrease obstructive sleep apnea risk and improve sleep quality by widening the upper jaw and airway.
How similar studies have performed: Previous rapid palatal expansion studies in adolescents have reported airway widening and some sleep-related improvements, but MARPE-specific evidence is more limited and results are mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Konya, Meram
- Necmettin Erbakan University — Konya, Meram, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Seda Sağoğlu
- Email: ssagoglu@gmail.com
- Phone: +905354121271
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rapid Maxillary Expansion, MARPE, STOP-BANG, PSQI