NCT02438280

Brief Summary

The AcceleDent® device has been introduced to the specialty of orthodontics in order to reduce treatment time. The theory behind AcceleDent® is that high frequency vibratory forces (30Hz) delivered to the teeth will stimulate the bone remodeling that is necessary for tooth movement to occur more quickly. Additionally, one claim of the AcceleDent® product is that it may reduce pain and discomfort during orthodontic treatment. This study will be a parallel group, triple-blind randomized clinical trial comparing two groups of subjects with 12 participants in each group. Subjects will be randomized to receive one of two vibrational units, which will differ in frequency and/or amplitude of vibration. The subjects will be asked to change their aligners every week instead of every 2 weeks, which is common with Invisalign.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

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

May 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 21, 2018

Completed
Last Updated

October 30, 2018

Status Verified

September 1, 2018

Enrollment Period

1.2 years

First QC Date

May 4, 2015

Results QC Date

November 6, 2017

Last Update Submit

September 30, 2018

Conditions

Tooth MovementMalocclusion

Keywords

OrthodonticOrthodontic treatmentAccelerated orthodonticsVibration

Outcome Measures

Primary Outcomes (1)

  • Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura)

    The outcome was the ability to complete the initial set of aligners using either an active vibration device or a placebo vibration device. Regardless of the group assignment, patients were asked to change their aligners each week, and we tracked the percentage that were able to complete their series of aligners.

    6 months

Secondary Outcomes (1)

  • Final Alignment Scores of the Upper and Lower Incisors

    6 months

Study Arms (2)

Active Vibration

EXPERIMENTAL

Use of Active Vibration (AcceleDent device) 20 minutes each day during treatment with aligners

Device: AcceleDent, Vibrational Device

Sham Vibration

ACTIVE COMPARATOR

Use of Sham Vibration (Sham AcceleDent device) 20 minutes each day during treatment with aligners

Device: AcceleDent, Vibrational Device

Interventions

AcceleDent, Vibrational DeviceDEVICE

20 minutes of vibration each day

Also known as: AcceleDent Aura
Active VibrationSham Vibration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with malocclusions that require minor or no anterior-posterior or transverse correction in the posterior teeth, and are planned for \<= 25 aligners to complete treatment.
  • Treatment must be dual arch in order for patients to qualify for this study.
  • Patients must be 18 years or older

You may not qualify if:

  • Patients with systematic diseases or syndromes
  • Patients with a history or current use of Bisphosphonates
  • Patients with current use of nonsteroidal anti-inflammatory drugs (NSAIDs)prostaglandin inhibitors.
  • Patients with generalized moderate to severe periodontitis
  • Patients with active oral hard tissue or soft tissue lesions
  • Patients with chronic oral and maxillofacial conditions such as trigeminal neuralgia, temporomandibular disorder and orofacial pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cohanim Smileworks

Seattle, Washington, 981122, United States

Location

Dr. Sandra Tai

Richmond, British Columbia, V7C 5L9, Canada

Location

Dr. Sandra Tai

Vancouver, British Columbia, V5H 4K7, Canada

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Limitations and Caveats

The number of aligners in the upper and lower arches for each patient were made equivalent, in order to end tooth movement at the same time in both arches.

Results Point of Contact

Title
Dr. Greg Huang, Professor and Chair of Orthodontics
Organization
University of Washington
ghuang@uw.edu
(206) 616-6996

Study Officials

  • Greg Huang

    UW

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Orthodontics

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 8, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2016

Study Completion

March 1, 2017

Last Updated

October 30, 2018

Results First Posted

August 21, 2018

Record last verified: 2018-09

Locations

CA(2)US(1)