Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-60
SponsorUniversity of Malaya

About this trial

The goal of this clinical trial is to learn whether miniscrew-assisted rapid palatal expansion (MARPE) can improve obstructive sleep apnea (OSA) in late adolescents and adults aged 16 to 60 years. The main questions it aims to answer are:

1. Does MARPE improve sleep apnea severity, as measured by Home Sleep Apnea Testing (HSAT), including respiratory event index (REI), oxygen desaturation index (ODI), mean oxygen saturation, nadir oxygen saturation, snoring events, and body position? 2. Does MARPE improve breathing and sleep-related symptoms, including upper airway dimensions, daytime sleepiness, quality of life, and peak nasal inspiratory flow (PNIF)?

Researchers will compare a MARPE group with a control group that receives standard care for obstructive sleep apnea for 3 months to see whether MARPE provides additional benefit.

Participants will:

1. Receive standard care for obstructive sleep apnea 2. Be randomly assigned to either MARPE plus standard care or standard care alone for 3 months 3. In the MARPE group, wear a miniscrew-assisted rapid palatal expander and activate it according to the study protocol 4. Visit the clinic for follow-up care and monitoring 5. Data will be collected at baseline (T0) and 3 months (T1). At both time points, participants in the MARPE group will be assessed using Home Sleep Apnea Testing (HSAT), cone beam computed tomography (CBCT), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10), and peak nasal inspiratory flow (PNIF). Participants in the control group will be assessed using HSAT, ESS, FOSQ-10, and PNIF.

Eligibility criteria

Qualifiers

AHI ≥ 5

Aged ≥ 16 and ≤ 60 years old

Presence of the upper first permanent molars

Presence of unilateral or bilateral posterior crossbite or maxillary transverse deficiency (considering intermolar width measurements, posterior teeth buccolingual incli- nation, and posterior crossbites) allowing meaningful maxillary expansion of at least 5mm

Disqualifiers

BMI ≥ 30 kg/m2

Basic Periodontal Examination (BPE) ≥ 3 or BPE markers* (root bifurcation lesions)

Mobile teeth (Mobility grade ≥ 1)

Pathology in the maxilla, such as substantial maxillary bone defects, or maxillary bone defects due to space-occupying cysts, tumors, etc.

Trial design

Treatments tested in this trial

  • Miniscrew-Assisted Rapid Palatal Expansion
  • Standard Care (in control arm)

Treatment groups

24 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators