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Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04378205
Enrollment
40
Registered
2020-05-07
Start date
2018-09-01
Completion date
2019-12-31
Last updated
2020-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Appliance

Keywords

Pulpal blood flow, Pfixed appliance, Alignment arch wire

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).

Interventions

PROCEDURE0.014-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.

PROCEDURE0.016-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.

Sponsors

Jordan University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Psarticipants did not know which size is allocated/side.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pulpal blood flow changesup to 4 weeksMeasurements were taken by the use of Laser Doppler Flowmeter mm/s

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026