Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion

The aim of the study is to compare a customized facemask for the treatment of Class III malocclusion in the prepubertal growing patient (patients between the ages of 5 and 12 years) versus a standard commercial facemask. Specifically, preference, pain, difficulty in sleeping, time of use, and possible complications for the two types of facemasks will be analyzed. This is a single-center, national, controlled, superiority, randomized, crossover, open-label study. Each patient will be treated with both the customized facemask and the standard commercial facemask. Each patient will wear one type of facemask for 2 months and the other type of facemask for the next 2 months. After 2 weeks and at the end of therapy with each of the facemask types, the patient, with the possible help of the parents, will have to answer a questionnaire about pain and difficulty sleeping and report any complications. In addition, after completing both phases (fourth month), the patient should indicate a preference for one of the two types of mask with which to complete therapy for an additional 6 months.

NCT Number	NCT06402656
Lead Sponsor	Azienda Ospedaliero-Universitaria Careggi
Conditions	Malocclusion, Angle Class III, Extraoral Traction Appliances
Enrollment	24 participants
Start Date	2024-09-01
Primary Completion	2025-01-01 (estimated)
Study Completion	2026-01-01 (estimated)
Updated on ClinicalTrials.gov	2024-07-31