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

Azienda Ospedaliero-Universitaria Careggi

Status

Not yet enrolling

Conditions

Malocclusion, Angle Class III

Extraoral Traction Appliances

Treatments

Device: Standard facemask

Device: Customized facemask

Study type

Interventional

Funder types

Other

Identifiers

NCT06402656

LF14

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

5 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 5 and 12 years;
Class III malocclusion, for which early orthopedic treatment with rapid maxillary expander and facemask is indicated.
signing of informed consent

Exclusion criteria