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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Faculty of Odontology, University Complutense Madrid
Madrid, Spain
RANKL concentration Baseline
Gingival crevicular fluid concentrations of RANKL at baseline
Time frame: Baseline
RANKL concentration at 6 weeks
Gingival crevicular fluid concentrations of RANKL at 6 weeks
Time frame: 6 weeks
RANKL concentration at 12 weeks
Gingival crevicular fluid concentrations of RANKL at 12 weeks
Time frame: 12 weeks
RANKL concentration at 18 weeks
Gingival crevicular fluid concentrations of RANKL at 18 weeks
Time frame: 18 weeks
OPG concentration Baseline
Gingival crevicular fluid concentrations of OPG at baseline
Time frame: Baseline
OPG concentration at 6 weeks
Gingival crevicular fluid concentrations of OPG at 6 weeks
Time frame: 6 weeks
OPG concentration at 12 weeks
Gingival crevicular fluid concentrations of OPG at 12 weeks
Time frame: 12 weeks
OPG concentration at 18 weeks
Gingival crevicular fluid concentrations of OPG at 18 weeks
Time frame: 18 weeks
Plaque index
Change in Löe and Silness plaque index scores from baseline to 18 weeks. Values range from 0-3, with higher values indicating more plaque
Time frame: Baseline and 18 weeks
Gingival index
Change in Lobenne modified gingival index from baseline to 18 weeks. Values range from 0-3, with higher values indicating more gingival inflammation
Time frame: Baseline and 18 weeks
Bleeding on probing index
Change in Bleeding on probing scores from baseline to 18 weeks. Values range from 0-3, with higher values indicating more gingival bleeding
Time frame: Baseline and 18 weeks
Orthodontic tooth movement achieved
Amount of tooth movement from baseline to 18 weeks (in mm), measuring tooth displacement from initial to the final position at week 18.
Time frame: Baseline and 18 weeks
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