search
Back to results

Nano-Crystalline Ceramic Coating of Orthodontic Archwires

Primary Purpose

Malocclusion

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ceramic coated orthodontic archwire
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring nano crystalline, archwire

Eligibility Criteria

10 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Ceramic Coated Orthodontic Archwire

    Control

    Arm Description

    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.

    The patients will receive the ordinary archwires. There is no intervention to the standard treatment.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2014
    Last Updated
    August 25, 2017
    Sponsor
    University of North Carolina, Chapel Hill
    Collaborators
    N2 Biomedical LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02311491
    Brief Title
    Nano-Crystalline Ceramic Coating of Orthodontic Archwires
    Official Title
    Nano-Crystalline Ceramic Coating for the Reduction of Sliding Resistance of Orthodontic Archwires
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding terminated
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of North Carolina, Chapel Hill
    Collaborators
    N2 Biomedical LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malocclusion
    Keywords
    nano crystalline, archwire

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ceramic Coated Orthodontic Archwire
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The patients will receive the ordinary archwires. There is no intervention to the standard treatment.
    Intervention Type
    Device
    Intervention Name(s)
    Ceramic coated orthodontic archwire
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Effective tooth movement in translation
    Description
    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.
    Time Frame
    12 weeks
    Title
    Effective tooth movement in rotation
    Description
    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.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: 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 Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ching-Chang Ko, DDS, PhD
    Organizational Affiliation
    UNC-CH
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Nano-Crystalline Ceramic Coating of Orthodontic Archwires

    We'll reach out to this number within 24 hrs