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Orthodontic Archwire Comparison Trial

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ClinicalTrials.gov Identifier: NCT02983084
Recruitment Status : Active, not recruiting
First Posted : December 6, 2016
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Indiana University
Information provided by (Responsible Party):
Ormco Corporation

Tracking Information
First Submitted Date  ICMJE November 29, 2016
First Posted Date  ICMJE December 6, 2016
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE December 1, 2016
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
Alignment of dental arches [ Time Frame: Initial six months of treatment ]
Tooth alignment rate in response to force from archwire measured in mm on dental models
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02983084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
  • Leveling of dental arches [ Time Frame: Initial six months of treatment ]
    Depth of the Curve of Spee (CoS): percent correction during the six month initial alignment
  • Expression of external apical root resorption (EARR) [ Time Frame: Initial six months of treatment ]
    Amount of root resorption in response to force from archwire calculated in 3D from the CBCT
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Orthodontic Archwire Comparison Trial
Official Title  ICMJE SmartWire Multiforce Archwire Clinical Trial
Brief Summary The purpose of this randomized clinical trial (RCT) is to compare traditional CuNiTi archwires and a recently marketed multiforce version of the same material for the initial alignment and leveling of dental arches, as well as the expression of EARR in adult orthodontic patients.
Detailed Description

This is a randomized clinical trial utilizing multiforce and CuNiTi orthodontic archwires to align and level dental arches and compare their results. A three group double blind parallel single site study at IUSD will be used.

Patients that meet the inclusion and exclusion criteria will be recruited from the IUSD orthodontic clinic. The subjects will be randomly assigned to one of the three groups by the study statistician. Subjects, examiners providing subject treatment, and examiners measuring study outcomes will be blinded to treatment assignment.

Study population indicates a sample size of 105 subjects, each group containing 35 clinical subjects.

Patients will be treated with Ormco Titanium Orthos fixed appliances and defined archwire sequence according to a clinical protocol. During the six-month study period, subjects will be seen approximately every 4 (four) weeks for regular standard of care appointments that will include archwire monitoring, photography and questionnaire completions. Final study records will be taken at the end of the study period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Malocclusion
Intervention  ICMJE Device: Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed appliance
Other Names:
  • Multiforce CuNiTi
  • CuNiTi
  • Copper Nickel Titanium
Study Arms  ICMJE
  • Experimental: Multiforce
    Variable modulus version of a current orthodontic archwire
    Intervention: Device: Orthodontic archwire
  • Active Comparator: CuNiTi A
    .016" current orthodontic archwire
    Intervention: Device: Orthodontic archwire
  • Active Comparator: CuNiTi B
    0.014" and 0.018" current orthodontic archwire sequence
    Intervention: Device: Orthodontic archwire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2016)
105
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult >14yrs of age
  • Amenable to treatment with metal brackets
  • Crowding of 3-8mm in one or both arches (non-extraction treatment)
  • Overbite >3mm
  • Read and speak English without a translator
  • Individuals in good general health at the discretion of the investigator(s)

Exclusion Criteria:

  • Medical/Dental History (Hx):

    • Documented metabolic disorder(s)
    • Nickel allergy
    • Bisphosphonate treatment
    • Amelogenesis, dentinogenesis or osteogenesis imperfect
    • Active caries or periodontal disease
    • Root resorption (moderate to severe)
    • Patients who are pregnant or breast feeding or plan to be pregnant during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02983084
Other Study ID Numbers  ICMJE 1608063565
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ormco Corporation
Study Sponsor  ICMJE Ormco Corporation
Collaborators  ICMJE Indiana University
Investigators  ICMJE
Principal Investigator: Kelton T Stewart, DDS, MS Indiana Unversity
PRS Account Ormco Corporation
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP