Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529601
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Comparison Between CADCAM and Conventional Mandibular Fixed Retainers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison Between CADCAM and Conventional Mandibular Fixed Retainers a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The devices compared in this study are retainers ie fixed orthodontic retainers applied to the lingual surface of the central and lateral incisors and lower canines bilaterally Their function is to maintain dental alignment once fixed orthodontic therapy has ended In particular the CADCAM device Keeppy patented by the company Leone SpA Via Ponte a Quaracchi 50 Sesto Fiorentino Florence will be compared with the standard retainer made from a steel braided wire Ortho FlexTech Reliance Orthodontic Products Inc 1540 West Thorndale Ave Itasca Illinois USA
This is a single-center national controlled superiority randomized crossover open-label study
The aim of this study is to evaluate whether the CADCAM retainer results in fewer failures fractures or detachments over a period of 6 months and 2 years compared to the standard retainer In addition the aim of the study is to evaluate whether the Keeppy device results in the maintenance of better periodontal health as judged by the use of plaque and bleeding indices on the surfaces of the lower six anterior teeth compared to the standard retainer Other objectives consist of the patients assessment of pain difficulty in speaking and esthetic satisfaction and the stability of the lower anterior tooth sector
This is a single-center national controlled superiority randomized crossover open-label study
The aim of this study is to evaluate whether the CADCAM retainer results in fewer failures fractures or detachments over a period of 6 months and 2 years compared to the standard retainer In addition the aim of the study is to evaluate whether the Keeppy device results in the maintenance of better periodontal health as judged by the use of plaque and bleeding indices on the surfaces of the lower six anterior teeth compared to the standard retainer Other objectives consist of the patients assessment of pain difficulty in speaking and esthetic satisfaction and the stability of the lower anterior tooth sector
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None