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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Customized facemask | Experimental |
| |
| Standard facemask | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Customized facemask | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 2 weeks and at 2 months after delivery of each of the 2 face masks |
| Difficulty in sleeping reported by patients |
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Inclusion Criteria:
Exclusion Criteria:
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IPD will be shared on appropriate request
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| ID | Term |
|---|---|
| D008313 | Malocclusion, Angle Class III |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Standard facemask | Device | The standard facemask is the commercially available Petit standard facemask |
|
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. |
| At 2 weeks and at 2 months after delivery of each of the 2 face masks |
| Number of complications | Number of complications | At 2 weeks and at 2 months after delivery of each of the 2 face masks |
| Total time wear | Total time wear measured with a thermosensor (Theramon) | At 2 months after delivery of each of the 2 face masks |