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Impact of tonsillectomy on the efficacy and stability of Alt-RAMEC/PFM protocols for children with class III malocclusion and tonsillar hypertrophy: A cluster randomized controlled trial (PROtraction facemask and Tonsillectomy RAndomized Clinical Trial (PROTRACT))

Impact of tonsillectomy on the efficacy and stability of Alt-RAMEC/PFM protocols for children with class III malocclusion and tonsillar hypertrophy: A cluster randomized controlled trial (PROtraction facemask and Tonsillectomy RAndomized Clinical Trial (PROTRACT))

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078833
Enrollment
Unknown
Registered
2023-12-19
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Tonsil hypertrophy

Interventions

Test group:The tonsillectomy and/or adenoidectomy and postoperative orthodontic treatment using Alt-RAMEC/PFM protocols
Active control group:The orthodontic treatment using Alt-RAMEC/PFM protocols (the tonsillectomy and/or adenoidectomy will be performed if necessary after the orthodontic treatment)

Sponsors

School & Hospital of Stomatology, Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 10 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria are as follows: 1. Patients before the peak of puberty as determined by the cervical vertebral maturation method (CVM stage 1-3), with an age range of 5 to 10 years old. 2. Presence of anterior crossbite and ANB 50% of oropharyngeal width) by otolaryngologists using the Brodsky grading scale, qualifying patients for tonsillectomy and/or adenotonsillectomy. 5. Demonstrating good oral hygiene, willingness to participate in the study, and adherence to treatment protocols. Acquisition of written informed consent from the participant’s legal guardian.

Exclusion criteria

Exclusion criteria: The exclusion criteria are as follows: 1. Acute upper respiratory infection. 2. Body mass index (BMI) >25kg/m2. 3. History of orthodontic treatment or adenotonsillectomy. 4. Patients with craniofacial abnormality, neuromuscular disease and cardiopulmonary disease.

Design outcomes

Primary

MeasureTime frame
Wits appraisal;A-Y variable;

Secondary

MeasureTime frame
The change in nocturnal sleep breathing;Sleep-related quality of life;Oral health-related quality of life;The morphologic change in upper airway dimension;The change in dentofacial morphology;

Countries

China

Contacts

Public ContactHong He

School & Hospital of Stomatology, Wuhan University

drhehong@whu.edu.cn+86 189 7166 2305

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026