Evaluation of trimline designs accuracy when using SureSmile Aligners
Research type
Research Study
Full title
A prospective, multicenter, randomized, post-market clinical investigation to assess the accuracy of different tooth movements for patients undergoing clear aligner therapy (CAT) with SureSmile® Clear Aligners and their differential trimline alternatives.
IRAS ID
366729
Contact name
Nina Shaffie
Contact email
Sponsor organisation
Dentsply Sirona Orthodontics (Sponsor representative Dentsply IH AB)
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 27 days
Research summary
This is a three-armed, multicenter clinical study evaluating the SureSmile clear aligner medical device. The primary objective is to confirm the safety and assess the accuracy of different tooth movements. In addition, the study will investigate and compare three different trimline designs: Scalloped, Straight, and Straight Extended.
In-vitro studies have shown that different trimline designs puts a different pressure pattern on the same tooth, and this study aims to validate these initial observations.
Subjects will receive study products (SureSmile® Clear Aligners – Full-Service Option) and will be randomized (by chance) into 1 of the three 3 groups.
This study is designed to follow the visit schedule observed in most orthodontic practices in the USA, United Kingdom and Spain (about every 8 weeks on average). It captures any safety or performance issues with the study products while in treatment for the past 8 weeks as well as the subjects' perception of comfort while wearing aligners for orthodontic treatment using a survey and VAS scale.
Around 9-12 standard visits are planned for each participating subject with additional visits being scheduled as needed for orthodontic reasons and not necessarily associated with the study. This will be follow-up visits unscheduled visits and will have the same structure as scheduled visits.The first subject is believed to be enrolled during December 2025 and the last subject completed is estimated during February 2028. The study is planned to be conducted at 6 centres (1 in UK, 1 in Spain, and 4 in USA) and enroll 90 subjects (30 per arm).
REC name
Wales REC 4
REC reference
26/WA/0060
Date of REC Opinion
24 Mar 2026
REC opinion
Further Information Favourable Opinion