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Treatment Efficacy of A Combined Rapid Maxillary Expansion and Adenotonsillectomy in Pediatric Obstructive Sleep Apnea: A Prospective Clinical Trial

Treatment Efficacy of A Combined Rapid Maxillary Expansion and Adenotonsillectomy in Pediatric Obstructive Sleep Apnea: A Prospective Clinical Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250224005
Enrollment
23
Registered
2025-02-24
Start date
2025-03-01
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

Patient age 4 to 1- years old who are diagnosed with Pediatric Obtructive Sleep Apnea by Type1 polysomnography. Adenotonsillectomy Rapid Palatal Expansion (RPE) Pediatric Obtructive Sleep Apne

Interventions

For adenotonsillectomy, the surgery will be performed according to the most recent clinical practice guidelines by American Academy of Otolaryngology-Head and Neck Surgery.,For a rapid maxillary expan
Active Comparator Procedure/Surgery,Experimental Procedure/Surgery

Sponsors

Faculaty of Dentistry, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Patients age between 4 to 10 years old, displaying clinical signs and symptoms, and confirmed a diagnosis of pediatric obstructive sleep apnea by Type I polysomnography. 2. Patients present with Adrenotonsillar enlargement (Adenotonsillar hypertrophy) Grade 2 or 3 and had persistence of clinical sign and symptoms of POSA at T1 after undergoing adenotonsillectomy, or Type I polysomnography displays residual AHI more than or equal to 2 3. Patients present narrowed and constricted maxilla with or without crossbite of posterior teeth, who have undergone treatment for POSA with rapid maxillary expansion (RME), and had persistence of clinical sign and symptoms at T1, or Type I polysomnography displays residual AHI more than or equal to 2

Exclusion criteria

Exclusion criteria: 1. Presence other significant pathologies include all craniofacial syndromes that could affect upper airway patency such as cleft lip and palate, a significant sagittal relationship (severe maxilla or mandible hypoplasia 2. Extreme obesity, a medical history limits adenotonsillectomy (severe heart disease, diabetes mellitus, etc.) 3. patient whose parents disallow them to participate in the study

Design outcomes

Primary

MeasureTime frame
Polysomnography study 6 months after end of treatment AHI (Apnea-hypopnea Index), Mean Blood Oxygen Saturation, Lowest Blood Oxygen Saturation, Sleep architecture,Clinical examination 6 months after end of the treatment Tonsillar scoring, Intercanine width and intermolar width, dental occlusion, Presence/Absence of posterior crossbite, palatal architecture,Radiographic Evaluation 6 months after end of the treatment Md-Hyoid, Anterior Facial Height, Adenoid scoring

Secondary

MeasureTime frame
Pediatric Sleep Questionaires 6 months after end of the treatment scoring ,Ouality of life 6 months after end of the treatment Opstructive sleep apnea -18 Ouality of life questionnaires

Countries

Thailand

Contacts

Public ContactAssociate Professor Supakit Peanchitlertkajorn

Faculty of Dentistry, Mahidol University

supakitpeanc@gmail.com66917754025

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026