NCT05316636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

6 years

First QC Date

March 21, 2022

Last Update Submit

March 30, 2022

Conditions

Orthodontic Tooth MovementGingival Crevicular FluidBiomarkers

Keywords

Vibration forces

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (4)

  • Plaque index

    Baseline and 18 weeks

  • Gingival index

    Baseline and 18 weeks

  • Bleeding on probing index

    Baseline and 18 weeks

  • Orthodontic tooth movement achieved

    Baseline and 18 weeks

Study Arms (3)

Group A

EXPERIMENTAL

Vibrational forces from onset of treatment, from weeks 0-6; then, no vibrational forces during the rest of the treatment

Device: Vibrational forcesProcedure: Orthodontic treatment with clear aligners

Group B

EXPERIMENTAL

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 forcesProcedure: Orthodontic treatment with clear aligners

Group C

ACTIVE COMPARATOR

Control, no vibrational forces

Procedure: Orthodontic treatment with clear aligners

Interventions

Vibrational forcesDEVICE
Group AGroup B
Orthodontic treatment with clear alignersPROCEDURE
Group AGroup BGroup C

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Odontology, University Complutense Madrid

Madrid, 28040, Spain

Location

Related Publications (1)

  • Teti L, Perez-Idarraga A, Salcedo-Miranda M, Cacho A, Yeste-Ojeda F, Martin C. Randomised Clinical Trial on the Effect of Intermittent Vibrational Force Application During Orthodontic Treatment With Aligners on Root Resorption. Orthod Craniofac Res. 2025 Dec;28(6):1015-1026. doi: 10.1111/ocr.70028. Epub 2025 Sep 10.

    PMID: 40927956DERIVED

MeSH Terms

Interventions

Orthodontics

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • Conchita Martin, Prof

    Faculty of Odontology, University Complutense Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2022

First Posted

April 7, 2022

Study Start

March 1, 2016

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

April 7, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)