Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium

NCT ID: NCT04378205

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-12-31

Brief 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.

Detailed 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).

Conditions

Orthodontic Appliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.014/0.018 NiTi arch wire

0.014-inch NiTi on one side /0.018-inch NiTi on the other side (Nitinol SuperElastic 3M, Unitek) for initial alignment. This group included 20 patients

Group Type: EXPERIMENTAL

0.014-inch NiTi on one side /0.018-inch NiTi on the other side

Intervention Type: PROCEDURE

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.

0.016/0.018 NiTi arch wire

0.016-inch NiTi on one side / 0.018-inch NiTi on the other side (Nitinol SuperElastic 3M, Unitek) for initial alignment. This group included 20 patients

Group Type: EXPERIMENTAL

0.016-inch NiTi on one side /0.018-inch NiTi on the other side

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Elham Abu Alhaija

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elham Abu Alhaija, PhD

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

Dental Faculty/Jordan university of Science and Technology Dental Teaching Clinics

Irbid, , Jordan

Countries

Jordan

Other Identifiers

39/2018

Identifier Type: -

Identifier Source: org_study_id