Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea | NCT07734688

NCT07734688

Overview

NCT ID: NCT07734688
Lead Sponsor: University of MalayaOTHER
Official Title: The Effectiveness of Miniscrew-Assisted Rapid Palatal Expansion in the Management of Obstructive Sleep Apnea: A Randomized Controlled Clinical Trial
Brief Summary: 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:

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?

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:

Receive standard care for obstructive sleep apnea

Be randomly assigned to either MARPE plus standard care or standard care alone for 3 months

In the MARPE group, wear a miniscrew-assisted rapid palatal expander and activate it according to the study protocol

Visit the clinic for follow-up care and monitoring

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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Feb 20, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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

Willingness to undergo MARPE treatment under the standard fee structure of the Faculty of Dentistry, Universiti Malaya

Exclusion Criteria:

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.

Significant true skeletal asymmetry

Presence of significant root resorption of upper first permanent molars due to previous orthodontic treatments

Concurrent on-going treatment for OSA such CPAP

Previous treatment for OSA such as soft tissue or hard tissue surgery within the past 4 months

Significant mandibular retrognathic (SNB less than normal value cephalometrically)

General chronic medical illnesses like cardiac failure, kidney failure, stroke etc.

Medication

Syndromic

Presence of neuropsychiatric illnesses such insomnia, narcolepsy, parasomnia etc.

Presence of neuromuscular diseases such multiple schlerosis, epilepsy, Parkinson's disease.

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Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 24Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Similar Studies

Participant Group/Arms

MARPEExperimental

Participants in the test group will receive standard care for obstructive sleep apnea (OSA), including lifestyle and conservative measures, medical management if indicated, and treatment of nasal obstruction as appropriate. In addition, participants will undergo maxillary skeletal expansion using a Mini-screw Assisted Rapid Palatal Expansion (MARPE) device (Maxillary Skeletal Expander II, MSE; Biomaterials Korea, Seoul, South Korea). The device will be custom-fabricated and anchored with mini-screws under local anaesthesia. Expansion will follow manufacturer instructions and continue with two turns per day until overcorrection is achieved. The device will then be retained in situ for approximately six months without further activation. Participants will be reviewed one week after placement and then 1-4 times per month depending on clinical need. During follow-up visits, pain, discomfort, oral hygiene, and compliance will be monitored.

Device: Miniscrew-Assisted Rapid Palatal Expansion

Wait-list ControlOther

This control group is a 3-month wait-list standard care arm for obstructive sleep apnea (OSA). During the trial period, participants will receive conservative and physician-directed management only, including lifestyle advice (e.g., weight management, sleep hygiene, positional therapy, and avoidance of alcohol or sedatives before sleep), medical management if indicated, and treatment of nasal obstruction as appropriate (e.g., topical nasal steroids or antihistamines). Participants will be monitored every 4 weeks and may receive rescue CPAP if clinically indicated. Unlike the experimental arm, no active maxillary expansion will be provided during the waiting period; MARPE will be offered after the 3-month assessment if they wish to undergo treatment.

Other: Standard Care (in control arm)