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

Study Overview
=================
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.

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

Conditions
-----------------
Tooth Movement, Malocclusion

Intervention / Treatment
-----------------
* Device: AcceleDent, Vibrational Device


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthodontic, Orthodontic treatment, Accelerated orthodontics, Vibration