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

Malocclusion, Angle Class III Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06402656
• Other study ID #: LF14
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: November 15, 2025

Study information

• Verified date: May 2024
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: November 15, 2025
• Est. primary completion date: November 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class III
• Prognathism

Intervention

Device:
• Customized 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.
• Standard facemask
The standard facemask is the commercially available Petit standard facemask

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	At 2 weeks and at 2 months after delivery of each of the 2 face masks
Secondary	Number of complications	Number of complications	At 2 weeks and at 2 months after delivery of each of the 2 face masks
Secondary	Total time wear	Total time wear measured with a thermosensor (Theramon)	At 2 months after delivery of each of the 2 face masks