Nano-Crystalline Ceramic Coating of Orthodontic Archwires

Nano-Crystalline Ceramic Coating for the Reduction of Sliding Resistance of Orthodontic Archwires

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.

Study Overview

• Status: Withdrawn
• Conditions: Malocclusion
• Intervention / Treatment: Device: Ceramic coated orthodontic archwire

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 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
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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:

1. Non-extraction treatment in mandible
2. Mandibular Little Index greater than or equal to 5 mm
3. Presence of all permanent anterior teeth
4. Age 10-45 years
5. Consent to participate in the study

Specific inclusion criteria for 2nd order tooth movement:

1. Space closure treatment need greater than or equal to 3 mm (extraction and/or non-extraction patients)
2. Space closure being carried out via sliding mechanics using power chains, spring coils, or interarch elastics
3. Age 10-45 years
4. Consent to participate in the study

Exclusion Criteria:

Specific exclusion criteria for 1st order tooth movement:

1. Systemic diseases such as diabetes, hypertension, temporomandibular disorders (TMD), craniofacial syndrome, etc.
2. Subjects who have incisor mandibular plane angle (IMPA) greater than or equal to 100 degrees
3. Anterior tooth completely blocked from the arch form
4. Periodontal pocketing of any lower anterior teeth greater than 4 mm

Specific exclusion criteria for 2nd order tooth movement:

1. Systemic diseases such as diabetes, hypertension, TMD, craniofacial syndrome, etc.
2. Space closure being carried out via closing loops
3. Periodontal pocketing greater than 4 mm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective tooth movement in translation	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.	12 weeks
Effective tooth movement in rotation	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.	12 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: N2 Biomedical LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: December 4, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimate): December 8, 2014

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: nano crystalline; archwire
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 13-0924

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No