N/A
Completed N=253
Primer Aligner Study
Malocclusion
Source: ClinicalTrials.gov NCT02550938 ↗
Enrolled (actual)
253
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Total Treatment Time — 197.4167; 225.7; 326.9355; 294.1111 days
Summary
To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Treatment Time |
197.4167; 225.7; 326.9355; 294.1111 | — |
| PRIMARY Rate of Refinement |
0.25; 0.263158; 0.419355; 0.527778 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have fully erupted dentition
- Age range ≥18 years old (Adult subject)
- Subjects who are indicated for either: 5, 7, 10, or 12 aligner sets
Exclusion Criteria
- Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
- Subject who has mixed dentition
- Subject with periodontal disease
- Subject with active caries
- Subject with Temporomandibular Joint Disorders symptoms
- Subject has undergone pre-treatment with any orthodontic appliance 3 months prior to the start of treatment
- Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study
- Subject has known allergy to latex or plastic
- Subjects who are pregnant or will become pregnant during treatment
Data sourced from ClinicalTrials.gov (NCT02550938). 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. Informational only — not medical advice.