MA Retro
Research type
Research Study
Full title
Mandibular Advancement Retrospective Case Collection Study
IRAS ID
274551
Contact name
Benjamin Cross
Contact email
Sponsor organisation
Align Technology, Inc.
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary
The purpose of this Retrospective Case Collection Study is to review from a post market clinical follow up perspective how Mandibular Advancement performs in the clinical field. The collected data on the Invisalign® System with Mandibular Advancement can be used for internal research and development purposes and product and services improvement. Data collected in this study may be used in future claims and/or publications.
Summary of Results
The direction of improvement was positive. Therefore, improvement of the Class II skeletal was favorable towards the direction of Class I.
The objective of this MA Retrospective Case Collection study was to collect data on pediatric patients (pre-teen and teen) for post market surveillance and internal purposes. The objective was met and there are no future plans to continue efforts related to this data collection in the future.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
19/WM/0353
Date of REC Opinion
11 Dec 2019
REC opinion
Favourable Opinion