Accelerated Invisalign Therapy in Conjunction With Acceledent Aura

NCT02868554 | Completed Results

• 1 other identifier: 16-0167
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion

Outcome Measures

Primary Outcomes (4)

• Little's Irregularity Index (LI) at Baseline

  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.

  Baseline (Week 0)

• Little's Irregularity Index at Final Stage

  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.

  End of Study (a total of approximately 12 weeks)

• Rate of Orthodontic Tooth Movement [Difference in Little's Irregularity Index, mm/Day]

  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.

  Baseline, 12 weeks

• Rate of Orthodontic Tooth Movement [Total % Change of Little's Irregularity Index]

  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.

  Baseline, 12 weeks

Secondary Outcomes (2)

• Activity of Bone Turnover Markers (BTMs) During Orthodontic Tooth Movement [Quantitative Polymerase Chain Reaction (qPCR), Cycle Threshold Values (Ct)]

  12 weeks

• Mean Patient Discomfort Score

  Week 12

Study Arms (3)

Standard Invisalign Therapy

NO INTERVENTION

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.

Accelerated Invisalign

EXPERIMENTAL

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

Accelerated Invisalign and Vibration

EXPERIMENTAL

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; Device: Accelerated Invisalign therapy

Interventions

AcceleDent Aura DEVICE

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.

Accelerated Invisalign and Vibration

Accelerated Invisalign therapy DEVICE

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.

Accelerated Invisalign; Accelerated Invisalign and Vibration

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females over the age of 18 years old desiring orthodontic treatment.
• 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.
• Normal pulp vitality and healthy periodontal tissues as determined by intraoral exam.
• Good health as determined by medical history.
• Willingness and ability to comply with study procedures, attend study visits, and complete the study.
• The ability to understand and sign a written informed consent form, which must be signed prior to initiation of study procedures.

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• OrthoAccel Technologies Inc.: collaborator

Study Sites (1)

UNC Department of Orthodontics

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (12)

• Sen B, Xie Z, Uzer G, Thompson WR, Styner M, Wu X, Rubin J. Intranuclear Actin Regulates Osteogenesis. Stem Cells. 2015 Oct;33(10):3065-76. doi: 10.1002/stem.2090.

  PMID: 26140478 BACKGROUND

• Uribe F, Padala S, Allareddy V, Nanda R. Patients', parents', and orthodontists' perceptions of the need for and costs of additional procedures to reduce treatment time. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4 Suppl):S65-73. doi: 10.1016/j.ajodo.2013.12.015.

  PMID: 24680026 BACKGROUND

• Ojima K, Dan C, Nishiyama R, Ohtsuka S, Schupp W. Accelerated extraction treatment with Invisalign. J Clin Orthod. 2014 Aug;48(8):487-99. No abstract available.

  PMID: 25226041 BACKGROUND

• Bowman SJ. The effect of vibration on the rate of leveling and alignment. J Clin Orthod. 2014 Nov;48(11):678-88. No abstract available.

  PMID: 25707947 BACKGROUND

• Orr MF, Ruckart PZ. Surveillance of hazardous substances releases due to system interruptions, 2002. J Hazard Mater. 2007 Apr 11;142(3):754-9. doi: 10.1016/j.jhazmat.2006.06.121. Epub 2006 Jul 3.

  PMID: 16920261 BACKGROUND

• Nishimura M, Chiba M, Ohashi T, Sato M, Shimizu Y, Igarashi K, Mitani H. Periodontal tissue activation by vibration: intermittent stimulation by resonance vibration accelerates experimental tooth movement in rats. Am J Orthod Dentofacial Orthop. 2008 Apr;133(4):572-83. doi: 10.1016/j.ajodo.2006.01.046.

  PMID: 18405822 BACKGROUND

• d'Apuzzo F, Cappabianca S, Ciavarella D, Monsurro A, Silvestrini-Biavati A, Perillo L. Biomarkers of periodontal tissue remodeling during orthodontic tooth movement in mice and men: overview and clinical relevance. ScientificWorldJournal. 2013 Apr 23;2013:105873. doi: 10.1155/2013/105873. Print 2013.

  PMID: 23737704 BACKGROUND

• Meikle MC. The tissue, cellular, and molecular regulation of orthodontic tooth movement: 100 years after Carl Sandstedt. Eur J Orthod. 2006 Jun;28(3):221-40. doi: 10.1093/ejo/cjl001. Epub 2006 May 10.

  PMID: 16687469 BACKGROUND

• Marie SS, Powers M, Sheridan JJ. Vibratory stimulation as a method of reducing pain after orthodontic appliance adjustment. J Clin Orthod. 2003 Apr;37(4):205-8; quiz 203-4. No abstract available.

  PMID: 12747073 BACKGROUND

• Xiong J, O'Brien CA. Osteocyte RANKL: new insights into the control of bone remodeling. J Bone Miner Res. 2012 Mar;27(3):499-505. doi: 10.1002/jbmr.1547.

  PMID: 22354849 BACKGROUND

• Leethanakul C, Suamphan S, Jitpukdeebodintra S, Thongudomporn U, Charoemratrote C. Vibratory stimulation increases interleukin-1 beta secretion during orthodontic tooth movement. Angle Orthod. 2016 Jan;86(1):74-80. doi: 10.2319/111914-830.1. Epub 2015 Mar 26.

  PMID: 25811245 BACKGROUND

• Nimeri G, Kau CH, Abou-Kheir NS, Corona R. Acceleration of tooth movement during orthodontic treatment--a frontier in orthodontics. Prog Orthod. 2013 Oct 29;14:42. doi: 10.1186/2196-1042-14-42.

  PMID: 24326040 BACKGROUND

Related Links

• OrthoAccel Technologies growth projections
• Sample study for inflammation Biomarkers

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Ching-Chang Ko, DDS, PhD
• Organization: University of North Carolina at Chapel Hill

ching-chang_ko@unc.edu

919-537-3763

Study Officials

• Ching C Ko, DDS, PhD

  UNC Department of Orthodontics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 16, 2016
• Study Start: August 1, 2016
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: January 27, 2020
• Results First Posted: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)