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

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Sham Vibration	AcceleDent, Vibrational Device	Use of Sham Vibration (Sham AcceleDent device) 20 minutes each day during treatment with aligners
Active Vibration	AcceleDent, Vibrational Device	Use of Active Vibration (AcceleDent device) 20 minutes each day during treatment with aligners

Primary Outcome Measures

Name	Time	Method
Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura)	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 Outcome Measures

Name	Time	Method
Final Alignment Scores of the Upper and Lower Incisors	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.