Comparing two types of clear aligners for orthodontic treatment
Randomized Clinical Trial on the Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement.
This study is testing whether a new type of clear aligner works better than a traditional one for fixing dental issues in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Sex | All |
| Sponsor | Universidad Complutense de Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06516185 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of direct-printed aligners versus conventional thermoformed aligners in treating various dental malpositions. Patients will be randomly assigned to receive one of the two types of aligners, and their treatment outcomes will be assessed based on the predictability of tooth movements. The study aims to establish a biomechanical planning protocol tailored to different types of tooth movements. Informed consent will be obtained from all participants, who can withdraw from the study at any time.
Who should consider this trial
Good fit: Ideal candidates are patients with malocclusion and individual dental malpositions requiring orthodontic treatment, who have good oral health and no history of previous orthodontic treatment.
Not a fit: Patients with altered bone metabolism or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and predictable orthodontic treatments for patients with malocclusion.
How similar studies have performed: While there is ongoing research in the field of clear aligner therapy, this specific comparison of direct-printed versus thermoformed aligners is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with malocclusion and invididual dental malpositions requiring orthodontic treatment * Adequate oral and periodontal health, with absence of periodontal disease, periapical infection or untreated caries. * No history of previous orthodontic treatment. * Complete permanent dentition (excluding third molars, their presence or absence being irrelevant). Exclusion Criteria: * Altered bone metabolism (including use of antiresorptive, steroid or immunosuppressive drugs). * Pregnant women.
Where this trial is running
Madrid
- Complutense University of Madrid — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Alejandro Piñeda-Zayas
- Email: apined01@ucm.es
- Phone: +34626923397
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.