Skip to main content
OpenTrials
Completed

NCT Number: NCT05316636

Intermittent Vibrational Force During Orthodontic Treatment With Aligners

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Orthodontic Tooth Movement Biomarkers Gingival Crevicular Fluid

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Odontology, University Complutense Madrid

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vibrational forces

Device

Orthodontic treatment with clear aligners

Procedure

Primary outcomes

  1. RANKL concentration Baseline

    Time frame: Baseline

    Gingival crevicular fluid concentrations of RANKL at baseline

  2. RANKL concentration at 6 weeks

    Time frame: 6 weeks

    Gingival crevicular fluid concentrations of RANKL at 6 weeks

  3. RANKL concentration at 12 weeks

    Time frame: 12 weeks

    Gingival crevicular fluid concentrations of RANKL at 12 weeks

  4. RANKL concentration at 18 weeks

    Time frame: 18 weeks

    Gingival crevicular fluid concentrations of RANKL at 18 weeks

  5. OPG concentration Baseline

    Time frame: Baseline

    Gingival crevicular fluid concentrations of OPG at baseline

  6. OPG concentration at 6 weeks

    Time frame: 6 weeks

    Gingival crevicular fluid concentrations of OPG at 6 weeks

  7. OPG concentration at 12 weeks

    Time frame: 12 weeks

    Gingival crevicular fluid concentrations of OPG at 12 weeks

  8. OPG concentration at 18 weeks

    Time frame: 18 weeks

    Gingival crevicular fluid concentrations of OPG at 18 weeks

Secondary outcomes

  1. Plaque index

    Time frame: Baseline and 18 weeks

    Change in Löe and Silness plaque index scores from baseline to 18 weeks. Values range from 0-3, with higher values indicating more plaque

  2. Gingival index

    Time frame: Baseline and 18 weeks

    Change in Lobenne modified gingival index from baseline to 18 weeks. Values range from 0-3, with higher values indicating more gingival inflammation

  3. Bleeding on probing index

    Time frame: Baseline and 18 weeks

    Change in Bleeding on probing scores from baseline to 18 weeks. Values range from 0-3, with higher values indicating more gingival bleeding

  4. Orthodontic tooth movement achieved

    Time frame: Baseline and 18 weeks

    Amount of tooth movement from baseline to 18 weeks (in mm), measuring tooth displacement from initial to the final position at week 18.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Spanish Society of Orthodontics (SEDO)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2022
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.