Clinical trial NCT05316636: Intermittent Vibrational Force During Orthodontic Treatment With Aligners
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Tooth Movement
Gingival Crevicular Fluid
Biomarkers
Keywords: Vibration forces
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Spanish Society of Orthodontics (SEDO)
First posted: 2022-04-07
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: RANKL concentration Baseline
timeFrame: Baseline
measure: RANKL concentration at 6 weeks
timeFrame: 6 weeks
measure: RANKL concentration at 12 weeks
timeFrame: 12 weeks
measure: RANKL concentration at 18 weeks
timeFrame: 18 weeks
measure: OPG concentration Baseline
timeFrame: Baseline
measure: OPG concentration at 6 weeks
timeFrame: 6 weeks
measure: OPG concentration at 12 weeks
timeFrame: 12 weeks
measure: OPG concentration at 18 weeks
timeFrame: 18 weeks
Secondary outcomes:
measure: Plaque index
timeFrame: Baseline and 18 weeks
measure: Gingival index
timeFrame: Baseline and 18 weeks
measure: Bleeding on probing index
timeFrame: Baseline and 18 weeks
measure: Orthodontic tooth movement achieved
timeFrame: Baseline and 18 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Faculty of Odontology, University Complutense Madrid
Study officials:
affiliation: Faculty of Odontology, University Complutense Madrid
name: Conchita Martin, Prof
role: PRINCIPAL_INVESTIGATOR
References: