Orthodontic Archwire Comparison Trial

Malocclusion Clinical Trial

Official title:

SmartWire Multiforce Archwire Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02983084
• Other study ID #: 1608063565
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: March 31, 2020

Study information

• Verified date: January 2019
• Source: Ormco Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• Orthodontic archwire
Archwire used to align teeth in an orthodontic fixed appliance

Locations

Country	Name	City	State
United States	IUSD Orthodontic Clinic	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Ormco Corporation	Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Leveling of dental arches	Depth of the Curve of Spee (CoS): percent correction during the six month initial alignment	Initial six months of treatment
Secondary	Expression of external apical root resorption (EARR)	Amount of root resorption in response to force from archwire calculated in 3D from the CBCT	Initial six months of treatment