Accelerated Tooth Movement With AcceleDent® and Aligners - a Pilot Project

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.

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Key information

Conditions

Tooth Movement Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Sandra Tai, Richmond, British Columbia, Canada

About this study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

AcceleDent, Vibrational Device

Device

20 minutes of vibration each day

Other names: AcceleDent Aura

Primary outcomes

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

Time frame: 6 months

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.

Secondary outcomes

Final Alignment Scores of the Upper and Lower Incisors

Time frame: 6 months

Final alignment was measured using Little's incisor irregularity index. This index sums the displacement of the contact points of the anterior teeth, to produce a millimetric number. The lower the score, the more perfect the alignment.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: May 8, 2015
Registry last updated: Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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