Viewing Study NCT06403033



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Last Modification Date: 2024-10-26 @ 3:29 PM
Study NCT ID: NCT06403033
Status: COMPLETED
Last Update Posted: 2024-05-09
First Post: 2024-05-03

Brief Title: Mini-implant-supported Twin-Block in Treating Patients With Class II Division 1 Malocclusion
Sponsor: Damascus University
Organization: Damascus University

Study Overview

Official Title: Evaluation of the Skeletal and Dentoalveolar Effects of Mini-implant-supported Twin-Block in Treating Growing Patients With Class II Division 1 Malocclusion A Two-arm Randomized Controlled Clinical Trial
Status: COMPLETED
Status Verified Date: 2024-05
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: Correcting the skeletal class II using functional appliances whether removable or fixed always leads to skeletal and alveolar effects However some of these effects are unfavorable the most significant being the loss of support in the lower dental arch This loss of support leads to an uncontrolled labial inclination of the lower incisors and mesial movement of the lower these dentoalveolar effects impact the degree of skeletal correction that can be achieved Therefore this study aimed to evaluate the skeletal and dentoalveolar effects following the use of a mini-implant-supported Twin-Block appliance compared to the conventional Twin-Block
Detailed Description: Many attempts have been made to modify the Twin-Block appliance to decrease the dentoalveolar effects such as omitting the upper labial bow including torquing spurs on the upper incisors and adding acrylic capping on the lower incisors However these modifications have not been successful in eliminating the dentoalveolar effects This is because the Twin-Block and other functional appliances are supported by teeth rather than bone As a result the components of the appliance exert force on the teeth while the mandible attempts to return to its natural resting position No previous clinical trial described the use of the Twin-Block appliance supported by orthodontic mini-implants and the potential benefits of using mini-implants with Twin-Block in functional treatment

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