The Effect of Autoclave Cycles on the Mechanical Properties and Surface Roughness of NITI Archwires

The Effect of Autoclave Cycles on the Mechanical Properties and Surface Roughness of NITI Archwires: Invivo Study.

The aim of this study is to evaluate the effect of different autoclave cycles (universal and rapid cycles) on the surface roughness and mechanical properties of NiTi archwires.

Study Overview

• Status: Recruiting
• Conditions: Not Determined
• Intervention / Treatment: Other: sterilization

Detailed Description

Three groups of 0.016 x 0.022 inch NiTi archwires (American Orthodontics, Wisconsin, USA) will be investigated in this study. The first group of wires will be investigated in the as-received form. The two other groups will be installed in the patients mouth for 4 weeks, and then retrieved, cleaned using ultrasonic cleaner, dried and packaged. The second group will be autoclaved through the rapid cycle (4 mins, 134oC) and the third group will be autoclaved through the universal cycle (20 mins, 121 oC). The autoclave used in this study is (Anthos A-17 Autoclave, Italy).

Each wire will be cut into 3 segments; 2 straight distal segment and one anterior curved segment. The distal segments will be used for tensile testing to derive the mechanical properties and the anterior segment will be used to measure the surface roughness.

The mechanical properties (load deflection curve) will be measured with a universal testing machine (Model 4466, Instron Corp, Canton, Mass) with a 1000-kg load cell at 37°C. Each wire segment will be placed in the jaws of the machine. A grip is positioned at each end of the wire with a distance of 40 mm between the jaws. The machine will be operated in the tensile mode with a crosshead speed of 5 mm per minute. Three characteristics of each sample will be quantified from the readouts: ultimate tensile strength (kg/mm2), elongation rate (%), and modulus of elasticity (kg/mm2).

Atomic force microscopy (AFM) is a non-invasive method for three dimensional analysis of surface roughness. Anterior archwire segments will be evaluated using the AFM (Anton Paar GmbH-Tosca200 AFM, Germany) employing the tapping mode 500 micrometer increment with a rate of 1 line per second. Average surface roughness (Sa) in nanometers will be obtained by software analysis (Mountains 8.2 Software-Digital Surf, Besancon, France). The average surface roughness of each specimen will be measured at three different sites and the mean (Sa) will then be calculated.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12588
    • Recruiting
    • Amira Aboalnaga
    • Contact: amira aboalnaga; Phone Number: 002-23635329; Email: amira_aboalnaga@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

orthodontic patients

Description

Inclusion Criteria:

• patients with moderate crowding requiring leveling and alignment

Exclusion Criteria:

• severe crowding.
• extraction cases

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
As-received NITI archwires; The first group of wires will be investigated in the as-received form (as received from the company without being used clinically).
Rapid cycle autoclaved NITI archwires; The second group of archwires will be will be installed in the patients mouth for 4 weeks, and then retrieved, cleaned using ultrasonic cleaner, dried and packaged and finally autoclaved using the rapid cycle (4 mins, 134oC)	Other: sterilization; autoclaving using the rapid cycle (4 mins, 134 oC) and the universal cycle (20 mins, 121 oC). The autoclave used in this study is (Anthos A-17 Autoclave, Italy).
Universal cycle autoclaved NITI archwires; the third group will be installed in the patients mouth for 4 weeks, and then retrieved, cleaned using ultrasonic cleaner, dried and packaged, the finally autoclaved using the universal cycle (20 mins, 121 oC)	Other: sterilization; autoclaving using the rapid cycle (4 mins, 134 oC) and the universal cycle (20 mins, 121 oC). The autoclave used in this study is (Anthos A-17 Autoclave, Italy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modulus of elasticity	springiness of the archwires	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surface roughness	surface roughness of the archwires	one month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: May 6, 2023
• First Submitted That Met QC Criteria: May 6, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: surface roughness; modulus of elasticity; NITI archwires; Autoclave cycle
• Other Study ID Numbers: CEBD-CU-2023-5-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No