Intermittent Vibrational Force During Orthodontic Treatment With Aligners

Not Applicable

Completed

• Conditions: Biomarkers; Orthodontic Tooth Movement; Gingival Crevicular Fluid
• Interventions: Device: Vibrational forces; Procedure: Orthodontic treatment with clear aligners

• Registration Number: NCT05316636
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-03
• Status Verified: 2022-03
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-30
• Last Update Submitted: 2022-03-30
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Vibrational forces	Vibrational forces from onset of treatment, from weeks 0-6; then, no vibrational forces during the rest of the treatment
Group B	Vibrational forces	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 A	Orthodontic treatment with clear aligners	Vibrational forces from onset of treatment, from weeks 0-6; then, no vibrational forces during the rest of the treatment
Group C	Orthodontic treatment with clear aligners	Control, no vibrational forces
Group B	Orthodontic treatment with clear aligners	From weeks 0-6, no vibrational forces. Vibrational forces starting at 6 weeks after treatment onset and applied for 6 weeks until week 12

Primary Outcome Measures

Name	Time	Method
RANKL concentration at 18 weeks	18 weeks	Gingival crevicular fluid concentrations of RANKL at 18 weeks
RANKL concentration at 6 weeks	6 weeks	Gingival crevicular fluid concentrations of RANKL at 6 weeks
OPG concentration at 6 weeks	6 weeks	Gingival crevicular fluid concentrations of OPG at 6 weeks
OPG concentration at 18 weeks	18 weeks	Gingival crevicular fluid concentrations of OPG at 18 weeks
RANKL concentration Baseline	Baseline	Gingival crevicular fluid concentrations of RANKL at baseline
RANKL concentration at 12 weeks	12 weeks	Gingival crevicular fluid concentrations of RANKL at 12 weeks
OPG concentration Baseline	Baseline	Gingival crevicular fluid concentrations of OPG at baseline
OPG concentration at 12 weeks	12 weeks	Gingival crevicular fluid concentrations of OPG at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Plaque index	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
Orthodontic tooth movement achieved	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.
Bleeding on probing index	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
Gingival index	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

Trial Locations

Locations (1)

Faculty of Odontology, University Complutense Madrid; 🇪🇸 Madrid, Spain