Clinical trial NCT02438280: Accelerated Tooth Movement With AcceleDent® and Aligners - a Pilot Project
Official title: Accelerated Tooth Movement With AcceleDent® and Aligners - a Pilot Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Movement
Malocclusion
Keywords: Orthodontic
Orthodontic treatment
Accelerated orthodontics
Vibration
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura)
timeFrame: 6 months
Secondary outcomes:
measure: Final Alignment Scores of the Upper and Lower Incisors
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Cohanim Smileworks
state: Washington
city: Richmond
country: Canada
facility: Dr. Sandra Tai
state: British Columbia
city: Vancouver
country: Canada
facility: Dr. Sandra Tai
state: British Columbia
Study officials:
affiliation: UW
name: Greg Huang
role: PRINCIPAL_INVESTIGATOR
References: