Orthodontic Archwire Comparison Trial

Ormco Corporation105 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

105

Conditions

Malocclusion

Interventions

Orthodontic archwireDEVICE

Archwire used to align teeth in an orthodontic fixed appliance

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

IUSD Orthodontic Clinic

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Alignment of dental arches

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

Time frame: Initial six months of treatment

Secondary Outcomes

Leveling of dental arches

Depth of the Curve of Spee (CoS): percent correction during the six month initial alignment

Time frame: Initial six months of treatment

Expression of external apical root resorption (EARR)

Amount of root resorption in response to force from archwire calculated in 3D from the CBCT

Time frame: Initial six months of treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.