NCT02983084

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3.1 years

First QC Date

November 29, 2016

Last Update Submit

January 14, 2019

Conditions

Malocclusion

Keywords

Orthodontic wiresRoot resorption

Outcome Measures

Primary Outcomes (1)

  • Alignment of dental arches

    Tooth alignment rate in response to force from archwire measured in mm on dental models

    Initial six months of treatment

Secondary Outcomes (2)

  • Leveling of dental arches

    Initial six months of treatment

  • Expression of external apical root resorption (EARR)

    Initial six months of treatment

Study Arms (3)

Multiforce

EXPERIMENTAL

Variable modulus version of a current orthodontic archwire

Device: Orthodontic archwire

CuNiTi A

ACTIVE COMPARATOR

.016" current orthodontic archwire

Device: Orthodontic archwire

CuNiTi B

ACTIVE COMPARATOR

0.014" and 0.018" current orthodontic archwire sequence

Device: Orthodontic archwire

Interventions

Orthodontic archwireDEVICE

Archwire used to align teeth in an orthodontic fixed appliance

Also known as: Multiforce CuNiTi, CuNiTi, Copper Nickel Titanium
CuNiTi ACuNiTi BMultiforce

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IUSD Orthodontic Clinic

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

MalocclusionRoot Resorption

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesTooth Resorption

Study Officials

  • Kelton T Stewart, DDS, MS

    Indiana Unversity

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 6, 2016

Study Start

December 1, 2016

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)