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.
57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.
This study's planned enrollment of 24 is below the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.
Browse Malocclusion, Angle Class III studies →Azienda Ospedaliero-Universitaria Careggi is the lead sponsor of 77 studies on the registry; 23 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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Malocclusion, Angle Class III →
Azienda Ospedaliero-Universitaria Careggi