Intermittent Vibrational Force During Orthodontic Treatment With Aligners

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial on the Effect of Intermittent Vibrational Force Application During Orthodontic Treatment With Aligners on RANKL and OPG Concentrations in Crevicular Fluid

Conditions
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Orthodontic Tooth Movement, Gingival Crevicular Fluid, Biomarkers

Intervention / Treatment
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* Device: Vibrational forces
* Procedure: Orthodontic treatment with clear aligners


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Vibrational forces from onset of treatment, from weeks 0-6; then, no vibrational forces during the rest of the treatment | Device: Vibrational forces<br> <br> Procedure: Orthodontic treatment with clear aligners<br> <br> |
| Experimental: Group B<br>From weeks 0-6, no vibrational forces. Vibrational forces starting at 6 weeks after treatment onset and applied for 6 weeks until week 12 | Device: Vibrational forces<br> <br> Procedure: Orthodontic treatment with clear aligners<br> <br> |
| Active Comparator: Group C<br>Control, no vibrational forces | Procedure: Orthodontic treatment with clear aligners<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RANKL concentration Baseline | Gingival crevicular fluid concentrations of RANKL at baseline | Baseline | 
| RANKL concentration at 6 weeks | Gingival crevicular fluid concentrations of RANKL at 6 weeks | 6 weeks | 
| RANKL concentration at 12 weeks | Gingival crevicular fluid concentrations of RANKL at 12 weeks | 12 weeks | 
| RANKL concentration at 18 weeks | Gingival crevicular fluid concentrations of RANKL at 18 weeks | 18 weeks | 
| OPG concentration Baseline | Gingival crevicular fluid concentrations of OPG at baseline | Baseline | 
| OPG concentration at 6 weeks | Gingival crevicular fluid concentrations of OPG at 6 weeks | 6 weeks | 
| OPG concentration at 12 weeks | Gingival crevicular fluid concentrations of OPG at 12 weeks | 12 weeks | 
| OPG concentration at 18 weeks | Gingival crevicular fluid concentrations of OPG at 18 weeks | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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. | Baseline and 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vibration forces