Status:
TERMINATED
OrthoPulse Gen 2 Initial Device Evaluation and Assessment of Clinical Effectiveness (CA)
Lead Sponsor:
Biolux Research Holdings, Inc.
Conditions:
Orthodontic Tooth Movement
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This is a prospective, interventional, non-randomized, control, split-mouth, open-label, single centre, private practice study aimed to evaluate the effect of tooth movement during orthodontic treatme...
Eligibility Criteria
Inclusion
- Patient must be 19 years of age or older
- Likely to be compliant to OrthoPulse use, aligner wear, and Dental Monitoring scanning
- Have a compatible iOS or Android device and are willing to download the OrthoPulse and Dental Monitoring apps for frequent automatic syncing of data
Exclusion
- Patient is currently enrolled in another clinical study
- Crowding or rotations of bilateral bicuspids that would prevent or interfere with intrusion
- Periodontally involved teeth, acute oral infection or periodontal disease
- Patient has active/untreated caries
- Use of bisphosphonates at any time
- Use of drugs that may cause photosensitivity
- History of photosensitivity
- Epilepsy
- Pregnant or planning pregnancy during the study.
- Patient plans to relocate over the treatment period
Key Trial Info
Start Date :
January 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2020
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04386278
Start Date
January 8 2020
End Date
June 24 2020
Last Update
November 23 2020
Active Locations (1)
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1
Dr. Peter Brawn
Vancouver, B.C, Canada, V6A 4G8