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Intermittent Vibrational Force During Orthodontic Treatment With Aligners

U

Universidad Complutense de Madrid

Status

Completed

Conditions

Orthodontic Tooth Movement
Biomarkers
Gingival Crevicular Fluid

Treatments

Procedure: Orthodontic treatment with clear aligners
Device: Vibrational forces

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

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:
Device: Vibrational forces
Procedure: Orthodontic treatment with clear aligners
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:
Device: Vibrational forces
Procedure: Orthodontic treatment with clear aligners
Group C
Active Comparator group
Description:
Control, no vibrational forces
Treatment:
Procedure: Orthodontic treatment with clear aligners

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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