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Accelerated Invisalign Therapy in Conjunction With Acceledent Aura

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02868554
Recruitment Status : Completed
First Posted : August 16, 2016
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
OrthoAccel Technologies Inc.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

Purpose:

The objective of this study is to investigate the effects of accelerated Invisalign and vibration therapy on rate of orthodontic tooth movement, activation of inflammation biomarkers as well as pain levels experienced by orthodontic patients during the initial 12 weeks of alignment.

Participants:

Up to 30 orthodontic patients of the University of North Carolina Orthodontic Residency Program will be recruited for this study. Patients older than 18 years old will be otherwise healthy subjects previously diagnosed with malocclusion.

Procedures (methods):

Each patient will be randomly allocated into either a control group or one of two intervention groups. Patients within the control group will receive standard Invisalign therapy without vibration. Patients within the intervention groups will receive accelerated Invisalign therapy with or without vibration. Patients receiving vibration therapy will utilize an AcceleDent Aura device which provides a light vibration at .25 Newtons (N) and 30 Hertz (Hz) frequency for twenty minutes daily. Three dimensional images of each subject's dentition will be recorded five times at 0 days, 4 days, 2 weeks, 6 weeks, and 12 weeks progress visits.


Condition or disease Intervention/treatment Phase
Malocclusion Device: AcceleDent Aura Device: Accelerated Invisalign therapy Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Orthodontic Tooth Movement With Accelerated Invisalign Therapy Using Acceledent Aura: A Randomized Clinical Trial
Study Start Date : August 2016
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : April 26, 2019

Arm Intervention/treatment
No Intervention: Standard Invisalign Therapy
Patients receiving standard Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 14 days of compliant aligner wear.
Experimental: Accelerated Invisalign
Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
Device: Accelerated Invisalign therapy
Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.

Experimental: Accelerated Invisalign and Vibration
In addition to the accelerated Invisalign protocol described in Arm #2, patients will undergo intraoral vibration therapy using an AcceleDent Aura device for a duration of 20 minutes per day.
Device: AcceleDent Aura
Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.

Device: Accelerated Invisalign therapy
Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.




Primary Outcome Measures :
  1. Little's Irregularity Index (LI) at Baseline [ Time Frame: Baseline (Week 0) ]
    Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.

  2. Little's Irregularity Index at Final Stage [ Time Frame: End of Study (a total of approximately 12 weeks) ]
    Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.

  3. Rate of Orthodontic Tooth Movement [Difference in Little's Irregularity Index, mm/Day] [ Time Frame: Baseline, 12 weeks ]
    The rate of orthodontic tooth movement (Little's Irregularity Index mm/day) will be evaluated. Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.

  4. Rate of Orthodontic Tooth Movement [Total % Change of Little's Irregularity Index] [ Time Frame: Baseline, 12 weeks ]
    The percent change in the irregularity index between the baseline and the final will be evaluated. Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.


Secondary Outcome Measures :
  1. Activity of Bone Turnover Markers (BTMs) During Orthodontic Tooth Movement [Quantitative Polymerase Chain Reaction (qPCR), Cycle Threshold Values (Ct)] [ Time Frame: 12 weeks ]
    Gingival crevicular fluid will be sampled to determine if vibratory stimulation during orthodontic tooth movement increases the activity of the Receptor Activator of Nuclear Factor-KappaB (RANK), Receptor Activator of Nuclear Factor-KappaB Ligand (RANKL) and Osteoprotegerin (OPG) cell signaling pathway.

  2. Mean Patient Discomfort Score [ Time Frame: Week 12 ]
    Research subjects asked to complete questionaire at Week 12 in order to determine what effect vibratory stimulation has on discomfort during orthodontic treatment. The FACES Pain Visual Analog Pain Scale was used to assess pain. Pain was assessed on a 0 (no pain) to 10 (worst pain) grading scale. Lower scores reflect lower pain levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females over the age of 18 years old desiring orthodontic treatment.
  2. Adult dentition with all upper and lower front teeth present and any premolar and molar combination in the upper posterior of two teeth on each side.
  3. Normal pulp vitality and healthy periodontal tissues as determined by intraoral exam.
  4. Good health as determined by medical history.
  5. Willingness and ability to comply with study procedures, attend study visits, and complete the study.
  6. The ability to understand and sign a written informed consent form, which must be signed prior to initiation of study procedures.

Exclusion Criteria:

  1. Patient under the age of 18 years old
  2. Women may not be pregnant. Negative urine pregnancy tests prior to exposure to cone beam imaging is required to verify pregnancy status.
  3. Patients diagnosed with systemic diseases such as diabetes, hypertension (high blood pressure), temporomandibular disorders (jaw disorders), or craniofacial syndromes.
  4. Severe malocclusions that would require adjunctive procedures other than Invisalign. These include impacted teeth, closure of extractions spaces.
  5. Significant periodontal disease (> 4mm pocket depth or >2 mm of recession on upper anterior teeth).
  6. Active caries not under care of either a dentist or periodontist.
  7. Chronic daily use of any non-steroidal anti-inflammatory medication, estrogen, calcitonin, or corticosteroids.
  8. History of use or current use of any bisphosphonate medication or other medication for treatment of osteoporosis.
  9. Current smoker (must not have smoked in the last 6 months).
  10. Failing to comply with research protocols

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868554


Locations
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United States, North Carolina
UNC Department of Orthodontics
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
OrthoAccel Technologies Inc.
Investigators
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Principal Investigator: Ching C Ko, DDS, PhD UNC Department of Orthodontics
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

Additional Information:
Publications:

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02868554    
Other Study ID Numbers: 16-0167
First Posted: August 16, 2016    Key Record Dates
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases