Accelerated Invisalign Therapy in Conjunction With Acceledent Aura (NCT02868554) | Clinical Trial Compass
CompletedNot Applicable
Accelerated Invisalign Therapy in Conjunction With Acceledent Aura
United States34 participantsStarted 2016-08
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Little's Irregularity Index (LI) at Baseline
Timeframe: Baseline (Week 0)
2
Little's Irregularity Index at Final Stage
Timeframe: End of Study (a total of approximately 12 weeks)
3
Rate of Orthodontic Tooth Movement [Difference in Little's Irregularity Index, mm/Day]
Timeframe: Baseline, 12 weeks
4
Rate of Orthodontic Tooth Movement [Total % Change of Little's Irregularity Index]