Accelerated Tooth Movement With AcceleDent® and Aligners

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tooth Movement Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Vibration

Use of Active Vibration (AcceleDent device) 20 minutes each day during treatment with aligners

Group Type EXPERIMENTAL

AcceleDent, Vibrational Device

Intervention Type DEVICE

20 minutes of vibration each day

Sham Vibration

Use of Sham Vibration (Sham AcceleDent device) 20 minutes each day during treatment with aligners

Group Type ACTIVE_COMPARATOR

AcceleDent, Vibrational Device

Intervention Type DEVICE

20 minutes of vibration each day

Interventions

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AcceleDent, Vibrational Device

20 minutes of vibration each day

Intervention Type DEVICE

Other Intervention Names

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AcceleDent Aura

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No