NCT06402656

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

Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion: Randomized Crossover Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria Careggi · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Malocclusion, Angle Class III
• Extraoral Traction Appliances

Interventions

Type	Name	Description
DEVICE	Customized facemask	The customized face mask will be fabricated from a 3D digital image of the patient's face obtained by means of a 3D scanner. Such a scanner consists of 6 digital SLR cameras and software capable of processing a 3-D image of the patient's face exportable as an stl file.
DEVICE	Standard facemask	The standard facemask is the commercially available Petit standard facemask

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-01-01
• Completion: 2026-01-01
• First posted: 2024-05-07
• Last updated: 2024-07-31