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

NCT06402656 | Not Yet Recruiting

• 1 other identifier: LF14
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malocclusion, Angle Class III; Extraoral Traction Appliances

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain reported by patients

  At 2 weeks and at 2 months after delivery of each of the 2 face masks

• Difficulty in sleeping reported by patients

  At 2 weeks and at 2 months after delivery of each of the 2 face masks

• Number of complications

  At 2 weeks and at 2 months after delivery of each of the 2 face masks

• Total time wear

  At 2 months after delivery of each of the 2 face masks

Study Arms (2)

Customized facemask

EXPERIMENTAL

Device: Customized facemask

Standard facemask

ACTIVE COMPARATOR

Device: Standard facemask

Interventions

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.

Customized facemask

Standard facemask DEVICE

The standard facemask is the commercially available Petit standard facemask

Standard facemask

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Cleft lip and/or palate.
• Craniofacial syndromes.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07