Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea

NCT07734688 | Not Yet Recruiting

• 1 other identifier: DF CD2605/0015 (P)
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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:

1. 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. 2.Does MARPE improve breathing and sleep-related symptoms, including upper airway dimensions, daytime sleepiness, quality of life, and peak nasal inspiratory flow (PNIF)?
3. 3.Receive standard care for obstructive sleep apnea
4. 4.Be randomly assigned to either MARPE plus standard care or standard care alone for 3 months
5. 5.In the MARPE group, wear a miniscrew-assisted rapid palatal expander and activate it according to the study protocol
6. 6.Visit the clinic for follow-up care and monitoring
7. 7.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.

Conditions

OSA - Obstructive Sleep Apnea; Palatal Expansion Technique

Keywords

obstructive sleep apnea; miniscrew-assisted rapid palatal expansion; MARPE; adult; palatal expansion technique

Outcome Measures

Primary Outcomes (1)

• Apnea Hyponea Index(AHI)

  "From treatment begin/recruited to the end of treatment/recruited at 3 months"

Secondary Outcomes (4)

• Cone Beam Computed Tomography

  "From treatment begin/ recruited to the end of treatment/recruited at 3 months"

• Epworth Sleepiness Scale

  "From treatment begin/ recruited to the end of treatment/recruited at 3 months"

• Functional Outcomes of Sleep Questionnaire Short Version

  "From treatment begin/ recruited to the end of treatment/recruited at 3 months"

• Peak Nasal Inspiratory Flow

  "From treatment begin/recruited to the end of treatment/recruited at 3 months"

Study Arms (2)

MARPE

EXPERIMENTAL

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 Control

OTHER

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)

Interventions

Miniscrew-Assisted Rapid Palatal Expansion DEVICE

This intervention uses a standardized miniscrew-assisted rapid palatal expansion (MARPE) protocol to achieve maxillary expansion in skeletally mature patients with obstructive sleep apnea. Unlike conventional tooth-borne rapid maxillary expansion (RME), MARPE is designed to achieve more skeletal expansion and reduce unwanted dental effects. Compared with surgically assisted expansion techniques such as SARPE and DOME, this intervention is non-surgical and focuses on correcting transverse maxillary deficiency as a contributing anatomical factor in upper airway narrowing.

Also known as: MARPE, palatal expansion technique, maxillary skeletal expansion, Maxillary skeletal expander, miniscrew-assisted rapid maxillary expansion

MARPE

Standard Care (in control arm) OTHER

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.

Wait-list Control

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Palatal Expansion Technique; Standard of Care

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthodontics, Corrective; Orthodontics; Dentistry; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The operator and participants will not be able to be blinded due to the nature of the study. Similarly, blinding of data collection for CBCT, ESS and FOSQ-10 is not feasible either. However, HSAT report synthesization will be blinded. As for data analysis, all data collected will be coded to enable blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): February 20, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07