Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium

Not Applicable

Completed

• Conditions: Orthodontic Appliance
• Interventions: Procedure: 0.014-inch NiTi on one side /0.018-inch NiTi on the other side; Procedure: 0.016-inch NiTi on one side /0.018-inch NiTi on the other side

• Registration Number: NCT04378205
• Lead Sponsor: Jordan University of Science and Technology

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).

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-05
• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-05-05
• Last Update Submitted: 2020-05-05
• Study First Posted: 2020-05-07
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.014/0.018 NiTi arch wire	0.014-inch NiTi on one side /0.018-inch NiTi on the other side	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
0.016/0.018 NiTi arch wire	0.016-inch NiTi on one side /0.018-inch NiTi on the other side	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

Primary Outcome Measures

Name	Time	Method
Pulpal blood flow changes	up to 4 weeks	Measurements were taken by the use of Laser Doppler Flowmeter mm/s

Trial Locations

Locations (1)

Dental Faculty/Jordan university of Science and Technology Dental Teaching Clinics; 🇯🇴 Irbid, Jordan