NCT02311491

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
2 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

Same day

First QC Date

December 4, 2014

Last Update Submit

August 25, 2017

Conditions

Malocclusion

Keywords

nano crystallinearchwire

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Ceramic Coated Orthodontic Archwire

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Ceramic coated orthodontic archwireDEVICE

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.

Ceramic Coated Orthodontic Archwire

Eligibility Criteria

Age10 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • In the initial or second stage of active treatment at the University of North Carolina graduate orthodontic clinic
  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Ching-Chang Ko, DDS, PhD

    UNC-CH

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 8, 2014

Study Start

December 1, 2016

Primary Completion

December 1, 2016

Study Completion

August 1, 2017

Last Updated

August 28, 2017

Record last verified: 2017-08