Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium

Orthodontic Appliance Clinical Trial

Official title:

Pulpal Blood Flow Changes Related to Using SuperElastic 0.018-inch Nickel Titanium as the First Orthodontic Alignment Archwire: A Prospective Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378205
• Other study ID #: 39/2018
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

to record pulpal blood flow (PBF) changes associated with using 0.018-inch Nickel Titanium (NiTi) as the first alignment archwire during fixed orthodontic treatment.

Description:

Forty healthy patients with lower arch mild crowding with less than 2mm contact point displacement at any teeth were included. A split mouth study design was applied. Where each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch.

Patients were assigned into one of 2 groups based on archwire sizes used. Group (1); 0.014-inch and 0.018-inch NiTi and Group (2); 0.016-inch and 0.018-inch NiTi. A Laser Doppler Flowmeter was used to measure PBF at different time intervals (T0-T5).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• age 18-25 years

• Class I skeletal malocclusion

• Mild lower arches crowding.

• Contact point displacement less than 2 mm.

• No previous orthodontic treatment

Exclusion Criteria:

• Missing teeth

• Poor oral hygiene

• deep carious teeth

• history of previous trauma

• any medical conditions affecting blood vessels

• smokers

Related Conditions & MeSH terms

• Orthodontic Appliance

Intervention

Procedure:
• 0.014-inch NiTi on one side /0.018-inch NiTi on the other side
Where each patient received 2 archwire sizes (0.014-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch.
• 0.016-inch NiTi on one side /0.018-inch NiTi on the other side
Where each patient received 2 archwire sizes (0.016-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch.

Locations

Country	Name	City	State
Jordan	Dental Faculty/Jordan university of Science and Technology Dental Teaching Clinics	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulpal blood flow changes	Measurements were taken by the use of Laser Doppler Flowmeter mm/s	up to 4 weeks