Randomized Clinical Trial on the Effect of Intermittent Vibrational Force Application During Orthodontic Treatment With Aligners on RANKL and OPG Concentrations in Crevicular Fluid
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Orthodontic Tooth Movement
- Sponsor
- Universidad Complutense de Madrid
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- OPG concentration Baseline
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients in need of treatment of malocclusion with Invisalign® (Align Technology, San Jose, CAL) using at least 14 sets of aligners
- •patients with good general health
Exclusion Criteria
- •smoking habit, poor oral hygiene, the presence of periodontal disease or any other chronic or systemic diseases that could affect bone metabolism or inflammation and the previous or current receipt of medications that could influence bone metabolism (e.g., bisphosphonates).
Outcomes
Primary Outcomes
OPG concentration Baseline
Time Frame: Baseline
Gingival crevicular fluid concentrations of OPG at baseline
RANKL concentration at 18 weeks
Time Frame: 18 weeks
Gingival crevicular fluid concentrations of RANKL at 18 weeks
RANKL concentration at 6 weeks
Time Frame: 6 weeks
Gingival crevicular fluid concentrations of RANKL at 6 weeks
OPG concentration at 6 weeks
Time Frame: 6 weeks
Gingival crevicular fluid concentrations of OPG at 6 weeks
OPG concentration at 18 weeks
Time Frame: 18 weeks
Gingival crevicular fluid concentrations of OPG at 18 weeks
RANKL concentration Baseline
Time Frame: Baseline
Gingival crevicular fluid concentrations of RANKL at baseline
RANKL concentration at 12 weeks
Time Frame: 12 weeks
Gingival crevicular fluid concentrations of RANKL at 12 weeks
OPG concentration at 12 weeks
Time Frame: 12 weeks
Gingival crevicular fluid concentrations of OPG at 12 weeks
Secondary Outcomes
- Plaque index(Baseline and 18 weeks)
- Orthodontic tooth movement achieved(Baseline and 18 weeks)
- Bleeding on probing index(Baseline and 18 weeks)
- Gingival index(Baseline and 18 weeks)