Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium

NCT04378205 | Completed

• 1 other identifier: 39/2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Appliance

Keywords

Pulpal blood flow; Pfixed appliance; Alignment arch wire

Outcome Measures

Primary Outcomes (1)

• Pulpal blood flow changes

  Measurements were taken by the use of Laser Doppler Flowmeter mm/s

  up to 4 weeks

Study Arms (2)

0.014/0.018 NiTi arch wire

EXPERIMENTAL

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

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

0.016/0.018 NiTi arch wire

EXPERIMENTAL

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

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

Interventions

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

0.014/0.018 NiTi arch wire

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

0.016/0.018 NiTi arch wire

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-25 years
• Class I skeletal malocclusion
• Mild lower arches crowding.
• Contact point displacement less than 2 mm.
• No previous orthodontic treatment

You may not qualify if:

• Missing teeth
• Poor oral hygiene
• deep carious teeth
• history of previous trauma
• any medical conditions affecting blood vessels
• smokers

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

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

Irbid, Jordan

Location

Study Officials

• Elham Abu Alhaija, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Psarticipants did not know which size is allocated/side.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A split mouth study design was applied. 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 Group 2:- 0.016-inch and 0.018-inch NiTi.

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 7, 2020
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)