Extraoral Traction Appliances, Malocclusion, Angle Class III
Conditions
Brief 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.
Interventions
DEVICECustomized 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.
DEVICEStandard facemask
The standard facemask is the commercially available Petit standard facemask
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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
* Cleft lip and/or palate. * Craniofacial syndromes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire on the preference of the patient for one of the two types of face masks | 4 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain reported by patients | At 2 weeks and at 2 months after delivery of each of the 2 face masks | 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 | At 2 weeks and at 2 months after delivery of each of the 2 face masks | 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 | At 2 weeks and at 2 months after delivery of each of the 2 face masks | Number of complications |
| Total time wear | At 2 months after delivery of each of the 2 face masks | Total time wear measured with a thermosensor (Theramon) |
Outcome results
None listed