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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malocclusion, Angle Class III; Extraoral Traction Appliances
• Intervention / Treatment: Device: Customized facemask; Device: Standard facemask

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Customized facemask	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.
Active Comparator: Standard facemask	Device: Standard facemask; The standard facemask is the commercially available Petit standard facemask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of complications	Number of complications	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)	At 2 months after delivery of each of the 2 face masks

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Malocclusion; Prognathism; Malocclusion, Angle Class III
• Other Study ID Numbers: LF14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be shared on appropriate request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No