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Completed

NCT Number: NCT04378205

Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium

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.

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Key information

Conditions

Orthodontic Appliance

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Irbid, Jordan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

0.016-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.

Primary outcomes

  1. Pulpal blood flow changes

    Time frame: up to 4 weeks

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

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 7, 2020
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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