Biomarkers, Gingival Crevicular Fluid, Orthodontic Tooth Movement
Conditions
Keywords
Vibration forces
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.
Interventions
DEVICEVibrational forces
PROCEDUREOrthodontic treatment with clear aligners
Sponsors
Spanish Society of Orthodontics (SEDO)
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OPG concentration Baseline | Baseline | Gingival crevicular fluid concentrations of OPG at baseline |
| RANKL concentration Baseline | Baseline | Gingival crevicular fluid concentrations of RANKL at baseline |
| RANKL concentration at 6 weeks | 6 weeks | Gingival crevicular fluid concentrations of RANKL at 6 weeks |
| RANKL concentration at 12 weeks | 12 weeks | Gingival crevicular fluid concentrations of RANKL at 12 weeks |
| RANKL concentration at 18 weeks | 18 weeks | Gingival crevicular fluid concentrations of RANKL at 18 weeks |
| OPG concentration at 6 weeks | 6 weeks | Gingival crevicular fluid concentrations of OPG at 6 weeks |
| OPG concentration at 12 weeks | 12 weeks | Gingival crevicular fluid concentrations of OPG at 12 weeks |
| OPG concentration at 18 weeks | 18 weeks | Gingival crevicular fluid concentrations of OPG at 18 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival index | Baseline and 18 weeks | Change in Lobenne modified gingival index from baseline to 18 weeks. Values range from 0-3, with higher values indicating more gingival inflammation |
| Bleeding on probing index | Baseline and 18 weeks | Change in Bleeding on probing scores from baseline to 18 weeks. Values range from 0-3, with higher values indicating more gingival bleeding |
| Orthodontic tooth movement achieved | Baseline and 18 weeks | Amount of tooth movement from baseline to 18 weeks (in mm), measuring tooth displacement from initial to the final position at week 18. |
| Plaque index | Baseline and 18 weeks | Change in Löe and Silness plaque index scores from baseline to 18 weeks. Values range from 0-3, with higher values indicating more plaque |
Countries
Spain
Outcome results
None listed