Clinical trial NCT05860738: The Effect of Autoclave Cycles on the Mechanical Properties and Surface Roughness of NITI Archwires
Official title: The Effect of Autoclave Cycles on the Mechanical Properties and Surface Roughness of NITI Archwires: Invivo Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Not Determined
Keywords: surface roughness
modulus of elasticity
NITI archwires
Autoclave cycle
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: orthodontic patients

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* patients with moderate crowding requiring leveling and alignment

Exclusion Criteria:

* severe crowding.
* extraction cases

Primary outcomes:
measure: modulus of elasticity
timeFrame: one month
Secondary outcomes:
measure: surface roughness
timeFrame: one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Amira Aboalnaga
Study officials:
References: