NCT05860738

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

May 6, 2023

Last Update Submit

September 5, 2023

Conditions

Not Determined

Keywords

surface roughnessmodulus of elasticityNITI archwiresAutoclave cycle

Outcome Measures

Primary Outcomes (1)

  • modulus of elasticity

    springiness of the archwires

    one month

Secondary Outcomes (1)

  • surface roughness

    one month

Study Arms (3)

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

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

Interventions

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).

Rapid cycle autoclaved NITI archwiresUniversal cycle autoclaved NITI archwires

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

orthodontic patients

You may qualify if:

  • patients with moderate crowding requiring leveling and alignment

You may not qualify if:

  • severe crowding.
  • extraction cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Aboalnaga

Cairo, 12588, Egypt

RECRUITING

MeSH Terms

Interventions

Sterilization

Intervention Hierarchy (Ancestors)

Infection ControlCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 6, 2023

First Posted

May 16, 2023

Study Start

May 4, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Locations

EG(1)