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.
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
Cleft lip and/or palate.
Craniofacial syndromes.
Crossover
Customized facemask
DeviceThe 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.
Standard facemask
DeviceThe standard facemask is the commercially available Petit standard facemask
Questionnaire on the preference of the patient for one of the two types of face masks
The primary endpoint is a questionnaire on the preference between the two types of face masks at the end of the second phase of therapy (4 months after delivery of the first face mask)
Pain reported by patients
Pain measured through Visual Analogue Scale with minimum value of 0 and maximum value of 10. Higher scores mean worse pain.
Difficulty in sleeping reported by patients
Difficulty in sleeping measured through VAS Visual Analogue Scale with minimum value of 0 and maximum value of 10. Higher scores mean more difficulty in sleeping.
Number of complications
Number of complications
Total time wear
Total time wear measured with a thermosensor (Theramon)
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