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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

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.

Condition or disease Intervention/treatment Phase
Malocclusion Device: Orthodontic archwire Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SmartWire Multiforce Archwire Clinical Trial
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Arm Intervention/treatment
Experimental: Multiforce
Variable modulus version of a current orthodontic archwire
Device: Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed appliance
Other Names:
  • Multiforce CuNiTi
  • CuNiTi
  • Copper Nickel Titanium

Active Comparator: CuNiTi A
.016" current orthodontic archwire
Device: Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed appliance
Other Names:
  • Multiforce CuNiTi
  • CuNiTi
  • Copper Nickel Titanium

Active Comparator: CuNiTi B
0.014" and 0.018" current orthodontic archwire sequence
Device: Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed appliance
Other Names:
  • Multiforce CuNiTi
  • CuNiTi
  • Copper Nickel Titanium




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02983084


Locations
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United States, Indiana
IUSD Orthodontic Clinic
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Ormco Corporation
Indiana University
Investigators
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Principal Investigator: Kelton T Stewart, DDS, MS Indiana Unversity

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Responsible Party: Ormco Corporation
ClinicalTrials.gov Identifier: NCT02983084     History of Changes
Other Study ID Numbers: 1608063565
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ormco Corporation:
Orthodontic wires
Root resorption
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases