Intermittent Vibrational Force During Orthodontic Treatment With Aligners

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2022-03-01

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.

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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.

Conditions

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Orthodontic Tooth Movement Gingival Crevicular Fluid Biomarkers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group A

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

Group Type EXPERIMENTAL

Vibrational forces

Intervention Type DEVICE

Orthodontic treatment with clear aligners

Intervention Type PROCEDURE

Group B

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

Group Type EXPERIMENTAL

Vibrational forces

Intervention Type DEVICE

Orthodontic treatment with clear aligners

Intervention Type PROCEDURE

Group C

Control, no vibrational forces

Group Type ACTIVE_COMPARATOR

Orthodontic treatment with clear aligners

Intervention Type PROCEDURE

Interventions

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Vibrational forces

Intervention Type DEVICE

Orthodontic treatment with clear aligners

Intervention Type PROCEDURE

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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No