An interventional study of Customized facemask and Standard facemask in Malocclusion, Angle Class III and Extraoral Traction Appliances, sponsored by Azienda Ospedaliero-Universitaria Careggi. Not yet recruiting. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Azienda Ospedaliero-Universitaria Careggi · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Device: Customized facemask
Device: Standard 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.
The 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)
Time frame: 4 months
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.
Time frame: At 2 weeks and at 2 months after delivery of each of the 2 face masks
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.
Time frame: At 2 weeks and at 2 months after delivery of each of the 2 face masks
Number of complications
Number of complications
Time frame: 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)
Time frame: At 2 months after delivery of each of the 2 face masks
No study locations are listed for this record.
Plan to share: Undecided — IPD will be shared on appropriate request
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliero-Universitaria Careggi