N/A
N=27
Accelerated Tooth Movement With AcceleDent® and Aligners - a Pilot Project
Tooth Movement · Malocclusion
Bottom Line
View on ClinicalTrials.gov: NCT02438280 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura) — 10; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AcceleDent, Vibrational Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura) |
10; 11 | — |
| SECONDARY Final Alignment Scores of the Upper and Lower Incisors |
2.2; 2.1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02438280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.