Not DeterminedNCT05860738
The Effect of Autoclave Cycles on the Mechanical Properties and Surface Roughness of NITI Archwires
An observational study of Not Determined, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Not Determined
- What is being tested?
- sterilization
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 4 May 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: orthodontic patients
Who may be able to join
- patients with moderate crowding requiring leveling and alignment
Who cannot join
- severe crowding.
- extraction cases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Amira Aboalnaga
Cairo, 12588
amira aboalnaga, 002-23635329, amira_aboalnaga@dentistry.cu.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Not Determined
- Being tested
- sterilization
- Keywords
- surface roughness, modulus of elasticity, NITI archwires, Autoclave cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sterilizationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: sterilization | |
| 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) Receives: Other: sterilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
modulus of elasticity
springiness of the archwires
Measured: one month
Secondary outcomes (1)
surface roughness
surface roughness of the archwires
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start4 May 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Not DeterminedStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Aboalnaga, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860738
- Sponsor's protocol ID
- CEBD-CU-2023-5-6
- Status last verified
- Sep 2023
- First submitted
- 6 May 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Autoclave Cycles on the Mechanical Properties and Surface Roughness of NITI Archwires: Invivo Study.
- ClinicalTrials.gov ID
- NCT05860738
- Acronym / sponsor ID
- CEBD-CU-2023-5-6
- Conditions
- Not Determined
- Keywords
- surface roughness, modulus of elasticity, NITI archwires, Autoclave cycle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: sterilizationThe 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) |
| Universal cycle autoclaved NITI archwires | – | Other: sterilizationthe 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- orthodontic patients
Key inclusion criteria (1 listed)
- patients with moderate crowding requiring leveling and alignment
Key exclusion criteria (2 listed)
- severe crowding.
- extraction cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sterilizationautoclaving 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). | Other | Rapid cycle autoclaved NITI archwires, Universal cycle autoclaved NITI archwires |
Primary outcome
modulus of elasticity
Time frame: one month
springiness of the archwires
1 secondary outcome
surface roughness
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Not Determined, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modulus of elasticity (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.