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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02267824 |
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Date of registration:
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10/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment
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Scientific title:
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The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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101 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02267824 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Thailand
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United States
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Contacts
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Name:
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Chung H Kau, DDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alabama (UAB) Birmingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Permanent dentition
- Class I malocclusion with irregularity score of greater than 2 mm in either arch
- Good oral hygiene
Exclusion Criteria:
- Any medical or dental condition that could potentially affect study results
- Patients currently using any investigational drug or any other investigational device
- Patients planning to relocate or move during the treatment period
- Use of bisphosphonates
- Pregnant females
Age minimum:
11 Years
Age maximum:
40 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malocclusion
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Intervention(s)
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Other: Fixed Orthodontic Appliance Treatment
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Device: Extraoral OrthoPulse® PBM
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Primary Outcome(s)
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Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients.
[Time Frame: Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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