Nano-Crystalline Ceramic Coating of Orthodontic Archwires
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|ClinicalTrials.gov Identifier: NCT02311491|
Recruitment Status : Withdrawn (Funding terminated)
First Posted : December 8, 2014
Last Update Posted : August 28, 2017
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.
Participants: Up to 80 subjects will be recruited for this study. Subjects between 10 years of age and 45 years old will be otherwise healthy subjects previously diagnosed with malocclusion.
Procedures (methods): Each subject will receive an experimental (coated) or a regular (uncoated control) orthodontic archwire (AW) for a 3-month treatment. The 3D digital images of each subject's dentition will be recorded three times at 0-, 6- and 12-week visits. The AW will be removed and retrieved after the 3-month trial.
|Condition or disease||Intervention/treatment||Phase|
|Malocclusion||Device: Ceramic coated orthodontic archwire||Not Applicable|
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 against tooth motion as the bracket slides along the wire into a new position. These ceramic coatings will produce more predictable outcomes, requiring less force and shorter treatment time. A limited clinical trial will be conducted to demonstrate these effects.
The aim of this project is to assess the clinical efficacy of the new archwires in Stage 1 (leveling and aligning) and Stage 2 (space closure) of orthodontic treatment using a twin bracket. The working hypothesis is that reduction of sliding resistance in bracket-wire interfaces will allow effective tooth movement in leveling, aligning, and sliding, while minimizing unwanted tooth movement such as lateral (mesio-distal direction) movement due to friction. This will be tested in a total of 80 patients who are undergoing active treatment in the University of North Carolina (UNC) orthodontic graduate clinic. These patients will be comprised of a treatment group (coated) and a control group (uncoated) of 20 each in Stage 1 and Stage 2 treatment.
A successful program will demonstrate a clinically significant increase in the amount and rate-of-change of tooth movement in leveling, aligning, and sliding teeth.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Nano-Crystalline Ceramic Coating for the Reduction of Sliding Resistance of Orthodontic Archwires|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||August 2017|
Experimental: Ceramic Coated Orthodontic Archwire
Ceramic coated orthodontic archwires will be evaluated in a limited clinical study at the university of North Carolina to test their efficacy in early and intermediate stages of tooth straightening in orthodontic patients.
Device: Ceramic coated orthodontic archwire
Hard ceramic coatings will reduce the sliding resistance of archwires in their brackets during orthodontic treatment procedures. The new coated archwire is expected to reduce treatment time.
No Intervention: Control
The patients will receive the ordinary archwires. There is no intervention to the standard treatment.
- Effective tooth movement in translation [ Time Frame: 12 weeks ]Clinical linear measurements (mm) in x-, y-, and z-translation at three time points (0-, 6-, and 12-weeks). A repeated measurement ANOVA model for the continuous clinical outcomes will be considered to test the proposed hypotheses.
- Effective tooth movement in rotation [ Time Frame: 12 weeks ]Clinical angular measurements (degree) in x-, y-, and z-rotation at three time points (0-, 6-, and 12-weeks). A repeated measurement ANOVA model for the continuous clinical outcomes will be considered to test the proposed hypotheses.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311491
|Principal Investigator:||Ching-Chang Ko, DDS, PhD||UNC-CH|