Trials / Completed
CompletedNCT05316636
Intermittent Vibrational Force During Orthodontic Treatment With Aligners
Randomized Clinical Trial on the Effect of Intermittent Vibrational Force Application During Orthodontic Treatment With Aligners on RANKL and OPG Concentrations in Crevicular Fluid
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Universidad Complutense de Madrid · Academic / Other
- Sex
- All
- Age
- 20 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
This three-arm cross-over randomized clinical trial (allocation ratio of 1:1:1) will aim to explore whether the application of intermittent vibratory forces modify RANKL and OPG concentrations in patients undergoing orthodontic treatment with clear aligners. The specific objective will be to compare gingival crevicular fluid concentrations of RANKL and OPG among groups according to the application or not of Acceledent® treatment at different time points and frequencies of aligner changes.
Detailed description
Application of intermittent forces by vibration is supposed to be an easy-to-use accelerator of dental movement. The purpose of this study is to determine the effect of intermittent vibrational force application during orthodontic aligner treatment on RANKL and OPG concentrations in crevicular fluid as markers of bone remodelling. This randomized clinical trial will include candidates for malocclusion treatment with aligners, randomly assigned to 3 groups: group A, vibrational forces from onset of treatment; group B, vibrational forces at 6 weeks after treatment onset; and group C, no vibration (controls). The frequency of aligner adjustment will also differ among groups and measurement time points. At different time points, a paper tip will be used to draw crevicular fluid samples from a moving lower incisor for RANKL and OPG analysis using ELISA kits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vibrational forces | |
| PROCEDURE | Orthodontic treatment with clear aligners |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2022-03-01
- Completion
- 2022-03-01
- First posted
- 2022-04-07
- Last updated
- 2022-04-07
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05316636. Inclusion in this directory is not an endorsement.