N/A
N=52
Evaluation of Clear Aligner Trays to Straighten Teeth
Malocclusion
Bottom Line
View on ClinicalTrials.gov: NCT03141788 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Successful Correction of Malocclusion — 32; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clear Aligner (Device)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- Solventum Orthodontics Corporation
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Correction of Malocclusion |
32; 20 | — |
| SECONDARY Individual Tooth Movement |
— | — |
| SECONDARY Treatment Time for Tooth Movement |
443 | — |
| SECONDARY Effective Use of Attachments |
5.4 | — |
| SECONDARY Orthodontist Satisfaction |
5; 33; 7; 2; 5 | — |
| SECONDARY Software Satisfaction |
— | — |
| SECONDARY Aligner Comfort |
24; 390; 41; 22; 2 | — |
| SECONDARY Appearance Satisfaction |
470; 9 | — |
| SECONDARY Aligner Ease of Cleaning |
436; 43 | — |
| SECONDARY Ease of Insertion |
364; 97; 15; 3 | — |
| SECONDARY Mid Course Corrections/Refinements Needed |
21; 19; 8; 4 | — |
| SECONDARY Ease of Aligner Removal |
308; 136; 32; 3 | — |
Summary
The objective of this study is to evaluate the efficacy of Clear Aligners to correct tooth malocclusions with the use of attachments and/or buttons, as determined by the amount of teeth movement and overall achievement goals of the treatment plan.
Eligibility Criteria
Inclusion Criteria
- Subject is at least 14 years of age.
- Subject is willing and able to give informed consent.
- Subject is willing to be digitally scanned at each 6-week visit, including after application of attachments.
- Subject has a need for single or double arch orthodontic treatment with a target duration of 18 months or less.
- Subject has good oral hygiene defined by the orthodontist.
- Subject has only permanent dentition.
Exclusion Criteria
- Subject has skeletal discrepancies requiring surgery
- Subject is undergoing active dental work
- Subject has severe open bite > 2 mm
- Subject has severe overjet > 4 mm
- Subject has deep bite > 3 mm
- Subject has over crowding per arch > 4 mm
- Subject has dental prostheses/implants that will interfere with projected teeth movement
- Subject is taking systemic steroid medication
- Subject is taking Biphosphonates or any other medication for treatment of osteoporosis
Data sourced from ClinicalTrials.gov (NCT03141788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.