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

Not Applicable

Not yet recruiting

• Conditions: Extraoral Traction Appliances; Malocclusion, Angle Class III
• Interventions: Device: Standard facemask; Device: Customized facemask

• Registration Number: NCT06402656
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-07
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31
• Study Start: 2024-09-01
• Primary Completion: 2025-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard facemask	Standard facemask	-
Customized facemask	Customized facemask	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of complications	At 2 weeks and at 2 months after delivery of each of the 2 face masks	Number of complications
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.
Total time wear	At 2 months after delivery of each of the 2 face masks	Total time wear measured with a thermosensor (Theramon)