Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-02
Brief Title:
Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion
Sponsor:
Azienda Ospedaliero-Universitaria Careggi
Organization:
Azienda Ospedaliero-Universitaria Careggi
Study Overview
Official Title:
Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion Randomized Crossover Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None