OrthoPulse 2.0 and 2.1 Feasibility Evaluation
Status unconfirmed · Not applicable
Conditions studied: Malocclusion
In brief
OrthoPulse is a device that uses near-infrared light therapy in order to decrease orthodontic treatment time. The aim of this study is to evaluate OrthoPulse products modified with extended arrays, OrthoPulse 2.0 and OrthoPulse 2.1, and to assess their clinical effectiveness.
Key facts
- Study ID
- NCT03683017
- Run by
- Biolux Research Holdings, Inc.
- People needed
- 35
- Starts
- 2017-12-22
- Expected to finish
- 2020-06-01
- Last updated by the study team
- 2019-10-22
Who can join
Age: 11 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Written Informed Consent must be obtained before any assessment is performed
- Patient must be 11 years of age or older; minors will only be included in the study with the consent of the Parent/Legal Authorized Representative (LAR)
- Presence of permanent dentition
- Eligible and scheduled for full mouth fixed orthodontic treatment or Invisalign
- Good oral hygiene
- Likely to be compliant to OrthoPulse 2.0 and 2.1 use, aligner wear and elastic wear
- Have a compatible iOS or Android device and are willing to download the OrthoPulse app for frequent automatic syncing of use data
You may not qualify if…
- Patient is currently enrolled in another clinical study
- Periodontally involved teeth, acute oral infection or periodontal disease
- Use of bisphosphonates (osteoporosis drugs) during the study
- Use of drugs that may cause photosensitivity
- History of photosensitivity
- History of poor oral hygiene, per the discretion of the Principal Investigator (PI)
- Epilepsy
- Patient plans to relocate over the treatment period
- Smoker or use of any tobacco containing products per the discretion of the PI
Where it is running
- Dickerson Orthodontics — Chandler, Arizona, United States
- Dickerson Orthodontics — Peoria, Arizona, United States
- Dickerson Orthodontics — Phoenix, Arizona, United States
- Dickerson Orthodontics — Scottsdale, Arizona, United States
- Bella Smile — San Francisco, California, United States
- Chenin Orthodontics — Henderson, Nevada, United States
- Sphinx Orthodontics — Edmonton, Alberta, Canada
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.