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Randomized Controlled Trial
. 2025 Jul 30;29(4):256.
doi: 10.1007/s11325-025-03427-8.

A randomized controlled trial comparing treatment efficacy between rapid maxillary expansion and adenotonsillectomy in pediatric obstructive sleep apnea

Affiliations
Randomized Controlled Trial

A randomized controlled trial comparing treatment efficacy between rapid maxillary expansion and adenotonsillectomy in pediatric obstructive sleep apnea

Chalermthai Aksilp et al. Sleep Breath. .

Abstract

Purpose: Adenotonsillectomy (AT) is usually recommended as the first-line therapy for pediatric obstructive sleep apnea (POSA). While AT treats soft tissue obstruction, it does not address the underlying skeletal abnormalities, such as maxillary constriction. Despite growing evidence supporting RME as a treatment option for POSA, a significant research gap remains. Therefore, we conducted a randomized controlled trial to compare treatment efficacy between RME and AT.

Methods: This study recruited 24 children diagnosed with POSA and presented with concurrent significant adenotonsillar hypertrophy and transverse maxillary deficiency. Participants were randomly assigned to either AT or RME for treatment. All participants underwent Type I PSG at baseline and 6 months post-treatment. Additional assessments included dental and cephalometric analyses, the pediatric sleep questionnaire (PSQ), and the OSA-18 questionnaire. Baseline and endpoint comparisons between the two treatment groups were performed.

Results: The median baseline AHI for the AT and RME groups was 7.0 (5.25-9.9) and 6.85 (5.6-8.05) events/hour, respectively. There was no significant difference between treatment groups in all parameters at baseline. The comparisons between pre- and post-treatment results showed significant improvements across multiple parameters, including AHI for both AT and RME. There was no significant difference in PSG parameters (AHI, LSAT, MSAT, and REM sleep time) and cure rate between RME and AT. The post-treatment AHI for the AT and RME groups was 1.4 (0.7-1.85) and 2.3 (1.15-5.7) events/hour, respectively. However, PSQ and OSA-18 scores were significantly higher for the RME group.

Conclusion: RME and AT significantly improved sleep-related respiratory parameters in patients with POSA. RME demonstrated comparable efficacy to AT in reducing AHI and improving LAST, MSAT, and REM sleep time. However, AT provided significantly better improvement in clinical symptoms and quality of life.

Trial registration: The registration of this randomized controlled trial was approved on August 24th, 2023, under the registration number TCTR20230824001.

Keywords: Adenotonsillectomy; Pediatric obstructive sleep apnea; Rapid maxillary expansion (RME); Transverse maxillary hypoplasia.

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Conflict of interest statement

Declarations. Ethical approval: The study is approved by the Institutional Review Board of the Faculty of Dentistry, Mahidol University (COA.No.MU-DT/PY-IRB 2022/061.2411). Consent to participate: Written informed consent was obtained from all participants. Conflict of interest: The authors have no competing interests to declare that are relevant to the content of this article.

Figures

Fig. 1
Fig. 1
Rapid maxillary expansion (RME) device
Fig. 2
Fig. 2
Trial flow chart. Twenty-four patients with confirmed POSA, adenotonsillar hypertrophy, and constricted maxilla, were recruited for the trial. They were assigned to either AT or RME for treatment using block randomization of 4. Baseline and 6-month assessments included PSG, Friedman’s classification, dental analysis, PSQ, and OSA-18 questionnaire

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