SureSmile Aligners for Misaligned Teeth

Not yet recruiting at 4 trial locations

Overseen By Freja Freedman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dentsply Sirona Implants and Consumables

Disqualifiers: Level 3 malocclusion, Active periodontal disease, TMJ disorders, Plastic allergies, Unstable psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 6-18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the SureSmile clear aligners, focusing on their safety and accuracy in moving teeth. It examines three designs of the aligners' edge: Scalloped, Straight, and Straight Extended. Individuals with slightly misaligned teeth (not more than 6mm of crowding or spacing) who haven't received orthodontic treatment in the past year may qualify. As an unphased trial, this study provides a unique opportunity to contribute to the development of innovative orthodontic solutions.

What prior data suggests that the SureSmile aligners are safe for correcting misaligned teeth?

Studies have shown that SureSmile Clear Aligners are generally easy to use. Their smooth edges help prevent mouth irritation, making them comfortable for most users. Additionally, SureSmile aligners can be customized, with edge designs like scalloped or straight to suit individual needs.

For the edge designs being tested—scalloped, straight, and straight extended—research has shown that these variations do not affect safety. The aligners are designed to be safe and effective, with no major side effects reported in past studies. This suggests that the aligners are a safe choice for those considering participation in the clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SureSmile® Clear Aligners because they offer a unique approach to aligning teeth with three distinct trimline designs. Unlike traditional braces or other clear aligners, SureSmile® options include an extended trimline, a scalloped trimline, and a straight trimline, each designed to optimize comfort and effectiveness. These variations might provide more customized treatment experiences, potentially enhancing fit and force distribution on teeth. This tailored approach could lead to improved outcomes and patient satisfaction compared to existing aligner options.

What evidence suggests that the SureSmile aligners are effective for misaligned teeth?

Research shows that SureSmile® Clear Aligners effectively straighten misaligned teeth. Studies have found that people using these aligners complete their treatment about 7 months faster than with traditional methods, achieving better alignment results. Known for its reliability, the system consistently straightens teeth. The current trial evaluates different aligner designs—scalloped, straight, and extended trimline—to assess their impact on tooth movement. Overall, SureSmile aligners have a strong history in orthodontics, providing reliable and effective results. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with misaligned teeth or malocclusion who are interested in trying SureSmile Clear Aligners. Specific details about eligibility criteria were not provided, so it's unclear who exactly can participate.

Inclusion Criteria

I am 18 years old or older.

All of my second molars have grown in.

I understand and agree to the risks, benefits, and time needed for this study.

Exclusion Criteria

Subjects unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator

Subject that presents a dental malocclusion classified as level 3 case complexity, as defined in the SureSmile Case Selection Guide

I finished my aligner therapy within the last year or am currently in treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SureSmile clear aligners with different trimline designs to assess tooth movement accuracy

6-18 months

Every 8 weeks

Refinement

Refinement of aligners based on initial treatment outcomes

8-12 weeks

Every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SureSmile® Clear Aligners

Trial Overview

The study is testing the safety and accuracy of SureSmile Clear Aligners in correcting teeth alignment. It compares three styles of aligner edges: Scalloped, Straight, and Straight Extended to see which works best.

How Is the Trial Designed?

Group I: Straight trimline design Experimental Treatment 1 Intervention

SureSmile® Clear Aligner (Group 2) with straight trimline design

Group II: Scalloped trimline design Experimental Treatment 1 Intervention

SureSmile® Clear Aligner (Group 1) with scalloped trimline design

Group III: Extended trimline design Experimental Treatment 1 Intervention

SureSmile® Clear Aligner (Group 3) with extended trimline design (2 mm)

Who Is Running the Clinical Trial?

Dentsply Sirona Implants and Consumables

Lead Sponsor

Trials

68

Recruited

4,800+

Simon Campion

Dentsply Sirona Implants and Consumables

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. Patrizia Cavazzoni

Dentsply Sirona Implants and Consumables

Chief Medical Officer

MD from Harvard Medical School

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5161459/

Clinical outcomes for patients finished with the SureSmile ...

Compared with conventional finishing, SS patients had significantly lower DI scores, less treatment time (∼7 months), and better CRE scores for first-order ...

2.

suresmile.com

suresmile.com/assets/files/suresmile-white-paper-1204.pdf

A proven system to predictably treat malocclusion

Clear aligners play an important role in the treatment of malocclusion. In the hands of a doctor, aligners can do more than improve esthetics by aligning the. “ ...

3.

us.dental-tribune.com

us.dental-tribune.com/c/dentsply-sirona/news/suresmile-clear-aligners-a-proven-system-for-predictably-treating-malocclusion/

SureSmile clear aligners

A proven system for predictably treating malocclusion.

4.

dentsplysirona.com

dentsplysirona.com/en-us/company/news-and-press-release-detail-page.html/content/dam/master/news/en/corporate-news/2024/suresmile-marks-30-years-of-innovation-in-orthodontics

SureSmile Marks 30 Years of Innovation in Orthodontics

Misaligned teeth affect not only dental health ... SureSmile® Clear Aligners Build Confidence in Treatment Process with Predictable Results.

5.

dentalcarekokomo.com

dentalcarekokomo.com/suresmile-vs-invisalign/

SureSmile® vs. Invisalign® | Which Aligner Fits You Best?

Compare SureSmile® and Invisalign® aligners, focusing on customization, cost, and treatment speed, to discover the best fit for your dream smile.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07290790

Study Details | NCT07290790 | A Prospective Multicenter ...

This is a three-armed, multicenter clinical study evaluating the SureSmile clear aligner medical device. The primary objective is to confirm ...

7.

ctv.veeva.com

ctv.veeva.com/study/a-prospective-multicenter-clinical-investigation-evaluating-the-accuracy-of-the-trimline-design-when

A Prospective Multicenter Clinical Investigation Evaluating the ...

This is a three-armed, multicenter clinical study evaluating the SureSmile clear aligner medical device. The primary objective is to confirm ...

8.

dentsplysirona.com

dentsplysirona.com/content/dam/master/regions-countries/north-america/usa/product-categories/orthodontics/SureSmile-downloads/documents/ORT-EN-US-document-SureSmile-GP-Brochure.pdf

SureSmile® Clear Aligners

Comfort comes in a variable trimline. With SureSmile® Clear Aligners, you can customize the design of your trimline. An automated, high-precision, laser ...