Orthodontic Archwire Comparison Trial

January 14, 2019 updated by: Ormco Corporation

SmartWire Multiforce Archwire Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IUSD Orthodontic Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Initial six months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Initial six months of treatment
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
Initial six months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ormco Corporation

Collaborators

Indiana University

Investigators

  • Principal Investigator: Kelton T Stewart, DDS, MS, Indiana Unversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1608063565

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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