Orthodontic Tooth MovementNCT05316636
Intermittent Vibrational Force During Orthodontic Treatment With Aligners
A study testing Vibrational forces and Orthodontic treatment with clear aligners in people with Orthodontic Tooth Movement and Gingival Crevicular Fluid, run by Universidad Complutense de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Orthodontic Tooth Movement, Gingival Crevicular Fluid, Biomarkers
- What is being tested?
- Vibrational forces and Orthodontic treatment with clear aligners
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2016to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Vibrational forces, Orthodontic treatment with clear aligners
- Keywords
- Vibration forces
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrational forcesDevice
Orthodontic treatment with clear alignersProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Vibrational forces from onset of treatment, from weeks 0-6; then, no vibrational forces during the rest of the treatment Receives: Device: Vibrational forces; Procedure: 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 Receives: Device: Vibrational forces; Procedure: Orthodontic treatment with clear aligners |
| Group C | Active comparator | Control, no vibrational forces Receives: Procedure: Orthodontic treatment with clear aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
RANKL concentration Baseline
Gingival crevicular fluid concentrations of RANKL at baseline
Measured: Baseline
RANKL concentration at 6 weeks
Gingival crevicular fluid concentrations of RANKL at 6 weeks
Measured: 6 weeks
RANKL concentration at 12 weeks
Gingival crevicular fluid concentrations of RANKL at 12 weeks
Measured: 12 weeks
RANKL concentration at 18 weeks
Gingival crevicular fluid concentrations of RANKL at 18 weeks
Measured: 18 weeks
OPG concentration Baseline
Gingival crevicular fluid concentrations of OPG at baseline
Measured: Baseline
OPG concentration at 6 weeks
Gingival crevicular fluid concentrations of OPG at 6 weeks
Measured: 6 weeks
OPG concentration at 12 weeks
Gingival crevicular fluid concentrations of OPG at 12 weeks
Measured: 12 weeks
OPG concentration at 18 weeks
Gingival crevicular fluid concentrations of OPG at 18 weeks
Measured: 18 weeks
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study startMar 2016
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Tooth MovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Orthodontics (SEDO)
- Responsible party
- Sponsor
- Investigators
- Conchita Martin, Prof, Principal investigator, Faculty of Odontology, University Complutense Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316636
- Sponsor's protocol ID
- C.P. - C.I. 15/313
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 40927956
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05316636
- Acronym / sponsor ID
- C.P. - C.I. 15/313
- Keywords
- Vibration forces
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Spanish Society of Orthodontics (SEDO)
- Study start
- Mar 2016 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Vibrational forces, Procedure: Orthodontic treatment with clear alignersVibrational forces from onset of treatment, from weeks 0-6; then, no vibrational forces during the rest of the treatment |
| Group B | Experimental | Device: Vibrational forces, Procedure: Orthodontic treatment with clear alignersFrom weeks 0-6, no vibrational forces. Vibrational forces starting at 6 weeks after treatment onset and applied for 6 weeks until week 12 |
| Group C | Active comparator | Procedure: Orthodontic treatment with clear alignersControl, no vibrational forces |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrational forces | Device | Group A, Group B |
| Orthodontic treatment with clear aligners | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
RANKL concentration Baseline
Time frame: Baseline
Gingival crevicular fluid concentrations of RANKL at baseline
RANKL concentration at 6 weeks
Time frame: 6 weeks
Gingival crevicular fluid concentrations of RANKL at 6 weeks
RANKL concentration at 12 weeks
Time frame: 12 weeks
Gingival crevicular fluid concentrations of RANKL at 12 weeks
RANKL concentration at 18 weeks
Time frame: 18 weeks
Gingival crevicular fluid concentrations of RANKL at 18 weeks
OPG concentration Baseline
Time frame: Baseline
Gingival crevicular fluid concentrations of OPG at baseline
OPG concentration at 6 weeks
Time frame: 6 weeks
Gingival crevicular fluid concentrations of OPG at 6 weeks
OPG concentration at 12 weeks
Time frame: 12 weeks
Gingival crevicular fluid concentrations of OPG at 12 weeks
OPG concentration at 18 weeks
Time frame: 18 weeks
Gingival crevicular fluid concentrations of OPG at 18 weeks
4 secondary outcomes
Plaque index
Time frame: Baseline and 18 weeks
Gingival index
Time frame: Baseline and 18 weeks
Bleeding on probing index
Time frame: Baseline and 18 weeks
Orthodontic tooth movement achieved
Time frame: Baseline and 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 40927956Teti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conchita Martin, Prof principal investigator
Faculty of Odontology, University Complutense Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrational forces and Orthodontic treatment with clear aligners in people with Orthodontic Tooth Movement and Gingival Crevicular Fluid, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RANKL concentration Baseline (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05316636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.