A Randomized Controlled Trial Comparing Treatment Efficacy Between Rapid Palatal Expansion and Adenotonsillectomy in Pediatric Obstructive Sleep Apnea

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230824001

Enrollment

Registered

2023-08-24

Start date

2023-08-29

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Pediatric obstructive sleep apnea (POSA) Pediatric Obstructive Sleep Apnea, Rapid Maxillary Exapnsion (RME), Adenotonsillectomy, Transverse Maxillary Hypoplasia

Interventions

Adenotonsillectomy was performed by a board-certified ENT surgeon following a clinical practice guideline by the American Academy of Otolaryngology-Head and Neck Surgery at the surgery center, QSNICH.

s stage of dental development. The RME featured a mid-palatal expansion screw (Hyrax, Maxi-12, Dentaurum, Germany) with arm extensions from anchor teeth to canine. It was delivered on a subsequent vis

Active Comparator Procedure/Surgery,Experimental Device

Adenotonsillectomy,Rapid maxillary expansion

Eligibility

Sex/Gender

All

Age

4 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Age between 4 to 10 years 2. Presence of signs and symptoms of POSA with AHI more than or equal to 1 confirmed by type I polysomnography (PSG) 3. Friedman's classification of tonsillar hypertrophy more than or equal to 2 according to an ENT evaluation 4. Narrow and constricted maxilla with or without posterior dental crossbite according to an orthodontic evaluation 5. Body mass index (BMI) less than 25 kilograms per square meter

Exclusion criteria

Exclusion criteria: 1. Presence of craniofacial syndromes, including oral clefts 2. Significant maxillary hypoplasia and mandibular hypoplasia in anteroposterior dimension according to cephalometric analyses 3. Medical conditions contraindicated in AT 4. History of orthodontic treatment and/or AT

Design outcomes

Primary

Measure	Time frame
Respiratory parameters 6 months after end of the first treatment (T1) Apnea-hypopnea Index (AHI)	—

Secondary

Measure	Time frame
Friedman's score 6 months after end of the first treatment (T1) Friedman's score,Mouth breathing 6 months after end of the first treatment (T1) Mouth breathing ,Clinical symptoms and quality of life 6 months after end of the first treatment (T1) PSQ and OSA-18 questionaire,Respiratory parameters 6 months after end of the first treatment (T1) Mean Blood Oxygen Saturation (MSAT), Lowest Blood Oxygen Saturation (LSAT),and REM sleep time	—

Measure

Time frame

Friedman's score 6 months after end of the first treatment (T1) Friedman's score,Mouth breathing 6 months after end of the first treatment (T1) Mouth breathing ,Clinical symptoms and quality of life 6 months after end of the first treatment (T1) PSQ and OSA-18 questionaire,Respiratory parameters 6 months after end of the first treatment (T1) Mean Blood Oxygen Saturation (MSAT), Lowest Blood Oxygen Saturation (LSAT),and REM sleep time

—

Countries

Thailand

Contacts

Public ContactAssociate Professor Dr. Supakit Peanchitlertkajorn

Faculty of Dentistry, Mahidol University

supakit.pea@mahidol.ac.th66917754025

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026