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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02438280
Other study ID # 49073
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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