Intermittent Vibrational Force During Orthodontic Treatment With Aligners

Biomarkers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05316636
• Other study ID #: C.P. - C.I. 15/313
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Biomarkers
• Gingival Crevicular Fluid
• Orthodontic Tooth Movement

Intervention

Device:
• Vibrational forces

Procedure:
• Orthodontic treatment with clear aligners

Locations

Country	Name	City	State
Spain	Faculty of Odontology, University Complutense Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Spanish Society of Orthodontics (SEDO)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RANKL concentration Baseline	Gingival crevicular fluid concentrations of RANKL at baseline	Baseline
Primary	RANKL concentration at 6 weeks	Gingival crevicular fluid concentrations of RANKL at 6 weeks	6 weeks
Primary	RANKL concentration at 12 weeks	Gingival crevicular fluid concentrations of RANKL at 12 weeks	12 weeks
Primary	RANKL concentration at 18 weeks	Gingival crevicular fluid concentrations of RANKL at 18 weeks	18 weeks
Primary	OPG concentration Baseline	Gingival crevicular fluid concentrations of OPG at baseline	Baseline
Primary	OPG concentration at 6 weeks	Gingival crevicular fluid concentrations of OPG at 6 weeks	6 weeks
Primary	OPG concentration at 12 weeks	Gingival crevicular fluid concentrations of OPG at 12 weeks	12 weeks
Primary	OPG concentration at 18 weeks	Gingival crevicular fluid concentrations of OPG at 18 weeks	18 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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