N/A
N=34
Accelerated Invisalign Therapy in Conjunction With Acceledent Aura
Malocclusion
Bottom Line
View on ClinicalTrials.gov: NCT02868554 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Little's Irregularity Index (LI) at Baseline — 6.11; 6.31; 6.89 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AcceleDent Aura (Device); Accelerated Invisalign therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Little's Irregularity Index (LI) at Baseline |
6.11; 6.31; 6.89 | — |
| PRIMARY Little's Irregularity Index at Final Stage |
4.97; 3.07; 4.52 | — |
| PRIMARY Rate of Orthodontic Tooth Movement [Difference in Little's Irregularity Index, mm/Day] |
0.0136; 0.0202; 0.0243 | 0.07 |
| PRIMARY Rate of Orthodontic Tooth Movement [Total % Change of Little's Irregularity Index] |
18.90; 23.71; 29.12 | 0.02 sig |
| SECONDARY Activity of Bone Turnover Markers (BTMs) During Orthodontic Tooth Movement [Quantitative Polymerase Chain Reaction (qPCR), Cycle Threshold Values (Ct)] |
— | — |
| SECONDARY Mean Patient Discomfort Score |
0.643; 1.583; 0.682 | — |
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.
Eligibility Criteria
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.
- 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
Data sourced from ClinicalTrials.gov (NCT02868554). 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.