NCT Number: NCT06402656
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.
Trial opening soon.
Get Notified5 year–12 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: At 2 weeks and at 2 months after delivery of each of the 2 face masks
Number of complications
Time frame: At 2 months after delivery of each of the 2 face masks
Total time wear measured with a thermosensor (Theramon)
Azienda Ospedaliero-Universitaria Careggi
Other
Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion: Randomized Crossover Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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