Orthodontic Archwire Comparison Trial
Primary Purpose
Malocclusion
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orthodontic archwire
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion focused on measuring Orthodontic wires, Root resorption
Eligibility 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
Sites / Locations
- IUSD Orthodontic Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Multiforce
CuNiTi A
CuNiTi B
Arm Description
Variable modulus version of a current orthodontic archwire
.016" current orthodontic archwire
0.014" and 0.018" current orthodontic archwire sequence
Outcomes
Primary Outcome Measures
Alignment of dental arches
Tooth alignment rate in response to force from archwire measured in mm on dental models
Secondary Outcome Measures
Leveling of dental arches
Depth of the Curve of Spee (CoS): percent correction during the six month initial alignment
Expression of external apical root resorption (EARR)
Amount of root resorption in response to force from archwire calculated in 3D from the CBCT
Full Information
NCT ID
NCT02983084
First Posted
November 29, 2016
Last Updated
January 14, 2019
Sponsor
Ormco Corporation
Collaborators
Indiana University
1. Study Identification
Unique Protocol Identification Number
NCT02983084
Brief Title
Orthodontic Archwire Comparison Trial
Official Title
SmartWire Multiforce Archwire Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ormco Corporation
Collaborators
Indiana University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Orthodontic wires, Root resorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multiforce
Arm Type
Experimental
Arm Description
Variable modulus version of a current orthodontic archwire
Arm Title
CuNiTi A
Arm Type
Active Comparator
Arm Description
.016" current orthodontic archwire
Arm Title
CuNiTi B
Arm Type
Active Comparator
Arm Description
0.014" and 0.018" current orthodontic archwire sequence
Intervention Type
Device
Intervention Name(s)
Orthodontic archwire
Other Intervention Name(s)
Multiforce CuNiTi, CuNiTi, Copper Nickel Titanium
Intervention Description
Archwire used to align teeth in an orthodontic fixed appliance
Primary Outcome Measure Information:
Title
Alignment of dental arches
Description
Tooth alignment rate in response to force from archwire measured in mm on dental models
Time Frame
Initial six months of treatment
Secondary Outcome Measure Information:
Title
Leveling of dental arches
Description
Depth of the Curve of Spee (CoS): percent correction during the six month initial alignment
Time Frame
Initial six months of treatment
Title
Expression of external apical root resorption (EARR)
Description
Amount of root resorption in response to force from archwire calculated in 3D from the CBCT
Time Frame
Initial six months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelton T Stewart, DDS, MS
Organizational Affiliation
Indiana Unversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
IUSD Orthodontic Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Orthodontic Archwire Comparison Trial
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