Back to resultsAccelerated Tooth Movement With AcceleDent® and Aligners - a Pilot Project
Primary Purpose
Tooth Movement, Malocclusion
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AcceleDent, Vibrational Device
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Movement focused on measuring Orthodontic, Orthodontic treatment, Accelerated orthodontics, Vibration
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.
Sites / Locations
- Cohanim Smileworks
- Dr. Sandra Tai
- Dr. Sandra Tai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active Vibration
Sham Vibration
Arm Description
Use of Active Vibration (AcceleDent device) 20 minutes each day during treatment with aligners
Use of Sham Vibration (Sham AcceleDent device) 20 minutes each day during treatment with aligners
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02438280
First Posted
May 4, 2015
Last Updated
September 30, 2018
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT02438280
Brief Title
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
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Movement, Malocclusion
Keywords
Orthodontic, Orthodontic treatment, Accelerated orthodontics, Vibration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Vibration
Arm Type
Experimental
Arm Description
Use of Active Vibration (AcceleDent device) 20 minutes each day during treatment with aligners
Arm Title
Sham Vibration
Arm Type
Active Comparator
Arm Description
Use of Sham Vibration (Sham AcceleDent device) 20 minutes each day during treatment with aligners
Intervention Type
Device
Intervention Name(s)
AcceleDent, Vibrational Device
Other Intervention Name(s)
AcceleDent Aura
Intervention Description
20 minutes of vibration each day
Primary Outcome Measure Information:
Title
Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Final Alignment Scores of the Upper and Lower Incisors
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Huang
Organizational Affiliation
UW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cohanim Smileworks
City
Seattle
State/Province
Washington
ZIP/Postal Code
981122
Country
United States
Facility Name
Dr. Sandra Tai
City
Richmond
State/Province
British Columbia
ZIP/Postal Code
V7C 5L9
Country
Canada
Facility Name
Dr. Sandra Tai
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5H 4K7
Country
Canada
12. IPD Sharing Statement
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Accelerated Tooth Movement With AcceleDent® and Aligners - a Pilot Project
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