Intermittent Vibrational Force During Orthodontic Treatment With Aligners

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

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.

Study Overview

• Status: Completed
• Conditions: Biomarkers; Orthodontic Tooth Movement; Gingival Crevicular Fluid
• Intervention / Treatment: Device: Vibrational forces; Procedure: Orthodontic treatment with clear aligners

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Faculty of Odontology, University Complutense Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Vibrational forces from onset of treatment, from weeks 0-6; then, no vibrational forces during the rest of the treatment	Device: Vibrational forces; Procedure: Orthodontic treatment with clear aligners
Experimental: 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	Device: Vibrational forces; Procedure: Orthodontic treatment with clear aligners
Active Comparator: Group C; Control, no vibrational forces	Procedure: Orthodontic treatment with clear aligners

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RANKL concentration Baseline	Gingival crevicular fluid concentrations of RANKL at baseline	Baseline
RANKL concentration at 6 weeks	Gingival crevicular fluid concentrations of RANKL at 6 weeks	6 weeks
RANKL concentration at 12 weeks	Gingival crevicular fluid concentrations of RANKL at 12 weeks	12 weeks
RANKL concentration at 18 weeks	Gingival crevicular fluid concentrations of RANKL at 18 weeks	18 weeks
OPG concentration Baseline	Gingival crevicular fluid concentrations of OPG at baseline	Baseline
OPG concentration at 6 weeks	Gingival crevicular fluid concentrations of OPG at 6 weeks	6 weeks
OPG concentration at 12 weeks	Gingival crevicular fluid concentrations of OPG at 12 weeks	12 weeks
OPG concentration at 18 weeks	Gingival crevicular fluid concentrations of OPG at 18 weeks	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index	Change in Löe and Silness plaque index scores from baseline to 18 weeks. Values range from 0-3, with higher values indicating more plaque	Baseline and 18 weeks
Gingival index	Change in Lobenne modified gingival index from baseline to 18 weeks. Values range from 0-3, with higher values indicating more gingival inflammation	Baseline and 18 weeks
Bleeding on probing index	Change in Bleeding on probing scores from baseline to 18 weeks. Values range from 0-3, with higher values indicating more gingival bleeding	Baseline and 18 weeks
Orthodontic tooth movement achieved	Amount of tooth movement from baseline to 18 weeks (in mm), measuring tooth displacement from initial to the final position at week 18.	Baseline and 18 weeks

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Spanish Society of Orthodontics (SEDO)
• Investigators: Principal Investigator: Conchita Martin, Prof, Faculty of Odontology, University Complutense Madrid

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Vibration forces
• Other Study ID Numbers: C.P. - C.I. 15/313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO