Intermittent Vibrational Force During Orthodontic Treatment With Aligners

Universidad Complutense de Madrid

Status: Completed

Conditions: Orthodontic Tooth Movement; Biomarkers; Gingival Crevicular Fluid

Treatments: Device: Vibrational forces; Procedure: Orthodontic treatment with clear aligners

Study type: Interventional

Funder types: Other

Identifiers

NCT05316636

C.P. - C.I. 15/313

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Group A

Experimental group

Description:

Vibrational forces from onset of treatment, from weeks 0-6; then, no vibrational forces during the rest of the treatment

Treatment:

Procedure: Orthodontic treatment with clear aligners

Device: Vibrational forces

Group B

Experimental group

Description:

From weeks 0-6, no vibrational forces. Vibrational forces starting at 6 weeks after treatment onset and applied for 6 weeks until week 12

Treatment:

Procedure: Orthodontic treatment with clear aligners

Device: Vibrational forces

Group C

Active Comparator group

Description:

Control, no vibrational forces

Treatment:

Procedure: Orthodontic treatment with clear aligners