Orthodontic Archwire Comparison Trial

Ormco

Status: Unknown

Conditions: Malocclusion

Treatments: Device: Orthodontic archwire

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02983084

1608063565

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups

Multiforce

Experimental group

Description:

Variable modulus version of a current orthodontic archwire

Treatment:

Device: Orthodontic archwire

CuNiTi A

Active Comparator group

Description:

.016" current orthodontic archwire

Treatment:

Device: Orthodontic archwire

CuNiTi B

Active Comparator group

Description:

0.014" and 0.018" current orthodontic archwire sequence

Treatment:

Device: Orthodontic archwire