Status:
WITHDRAWN
Nano-Crystalline Ceramic Coating of Orthodontic Archwires
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
N2 Biomedical LLC
Conditions:
Malocclusion
Eligibility:
All Genders
10-45 years
Phase:
NA
Brief Summary
Purpose: The project aims to assess if hard ceramic coatings on orthodontic archwires will reduce the sliding resistance of archwires in the brackets during orthodontic treatment procedures. Particip...
Detailed Description
In this trial, nano-crystalline ceramics will be applied to the surface of orthodontic archwires using ion beam assisted deposition to reduce sliding resistance. Excessive sliding resistance works aga...
Eligibility Criteria
Inclusion
- In the initial or second stage of active treatment at the University of North Carolina graduate orthodontic clinic
- Specific inclusion criteria for 1st order tooth movement:
- Non-extraction treatment in mandible
- Mandibular Little Index greater than or equal to 5 mm
- Presence of all permanent anterior teeth
- Age 10-45 years
- Consent to participate in the study
- Specific inclusion criteria for 2nd order tooth movement:
- Space closure treatment need greater than or equal to 3 mm (extraction and/or non-extraction patients)
- Space closure being carried out via sliding mechanics using power chains, spring coils, or interarch elastics
- Age 10-45 years
- Consent to participate in the study
Exclusion
- Specific exclusion criteria for 1st order tooth movement:
- Systemic diseases such as diabetes, hypertension, temporomandibular disorders (TMD), craniofacial syndrome, etc.
- Subjects who have incisor mandibular plane angle (IMPA) greater than or equal to 100 degrees
- Anterior tooth completely blocked from the arch form
- Periodontal pocketing of any lower anterior teeth greater than 4 mm
- Specific exclusion criteria for 2nd order tooth movement:
- Systemic diseases such as diabetes, hypertension, TMD, craniofacial syndrome, etc.
- Space closure being carried out via closing loops
- Periodontal pocketing greater than 4 mm
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02311491
Start Date
December 1 2016
End Date
August 1 2017
Last Update
August 28 2017
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