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.

Study Overview

• Status: Completed
• Conditions: Malocclusion; Tooth Movement
• Intervention / Treatment: Device: AcceleDent, Vibrational Device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Richmond, British Columbia, Canada, V7C 5L9
      • Dr. Sandra Tai
    • Vancouver, British Columbia, Canada, V5H 4K7
      • Dr. Sandra Tai
• United States
  • Washington
    • Seattle, Washington, United States, 981122
      • Cohanim Smileworks

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Treatment must be dual arch in order for patients to qualify for this study.
3. Patients must be 18 years or older

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Vibration; Use of Active Vibration (AcceleDent device) 20 minutes each day during treatment with aligners	Device: AcceleDent, Vibrational Device; 20 minutes of vibration each day; Other Names: AcceleDent Aura
Active Comparator: Sham Vibration; Use of Sham Vibration (Sham AcceleDent device) 20 minutes each day during treatment with aligners	Device: AcceleDent, Vibrational Device; 20 minutes of vibration each day; Other Names: AcceleDent Aura

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final Alignment Scores of the Upper and Lower Incisors	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.	6 months

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Greg Huang, UW

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: May 4, 2015
• First Submitted That Met QC Criteria: May 4, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: September 30, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Vibration; Orthodontic treatment; Accelerated orthodontics; Orthodontic
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 49073