Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion

NCT06402656 — Not applicable, Unknown, 24 participants, Azienda Ospedaliero-Universitaria Careggi

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion: Randomized Crossover Study

Registry	NCT06402656
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	24 (Estimated)
Sponsor	Azienda Ospedaliero-Universitaria Careggi (Other)
Conditions	Malocclusion, Angle Class III, Extraoral Traction Appliances
Interventions	Customized facemask, Standard facemask (Device)
Dates	start 2024-09-01 (estimated), primary completion 2025-01-01 (estimated), completion 2026-01-01 (estimated), first posted 2024-05-07, last updated 2024-07-31

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Customized facemask	Experimental	Device: Customized facemask
Standard facemask	Active comparator	Device: Standard facemask

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.
Standard facemask (Device): The standard facemask is the commercially available Petit standard facemask

+Outcome measures

Primary outcomes

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 outcomes

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)

+Eligibility

Sex: All, ages: 5 Years to 12 Years

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.