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

Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438280
• Other study ID #: 49073
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 2017

Study information

• Verified date: September 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Tooth Movement

Intervention

Device:
• AcceleDent, Vibrational Device
20 minutes of vibration each day

Locations

Country	Name	City	State
Canada	Dr. Sandra Tai	Richmond	British Columbia
Canada	Dr. Sandra Tai	Vancouver	British Columbia
United States	Cohanim Smileworks	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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