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Completed

NCT Number: NCT03772795

Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using Clear Aligners

The aims of this study were to: -

* Evaluate PBF in upper and lower teeth during orthodontic alignment using fixed appliances (0.014" super elastic NiTi arch wire) at different time intervals (20min, 48h, 72h and 1 month) of initial arch wire placement. * Evaluate the PBF in upper and lower teeth during orthodontic teeth alignment using clear aligners at different time intervals (20min ,48h, 72h and 1 month) of fitting the second aligner (first active aligner). * Compare the PBF changes between the above two different types of orthodontic appliances (fixed appliances and the clear aligners).

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Key information

Conditions

Alignment

Age range

16 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Aims: to evaluate the pulpal blood flow (PBF) during orthodontic teeth alignment and leveling using clear aligners (second aligner) and fixed orthodontic appliance at different time intervals of orthodontic force application.

Materials and Methods: A total of 45 subjects were subdivided in two groups: group 1: 25 subjects treated with pre-adjusted edgewise fixed appliance with 0.014 inch NiTi as the alignment arch wire and group 2: 20 subjects treated using clear aligner. In both groups, PBF was measured for the upper right and the lower left using Laser Doppler Flowmetry at different time interval (20 minutes, 48 hours, 72 hours, 1 month) after the fitting of the arch wire in group one and after the delivery of the second aligner in group two.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Both male and female subjects
  • 16 or more years old
  • Class I skeletal malocclusion
  • mild upper and lower arches crowding. Exclusion Criteria:-
  • Poor oral hygiene
  • Previous orthodontic treatment
  • Active periodontal disease
  • Missing teeth
  • Deep carious teeth
  • Teeth with root resorption
  • Endodontically treated teeth
  • History of previous trauma
  • Restoration on measured teeth
  • Medical conditions affecting blood vessels
  • Smoking

Treatment and study plan

Orthodontic Alignment

Other

Group 1:- Teeth alignment in this group started using round 0.014" NiTi arch wire. The 0.014" NiTi arch wire was placed into the slots of the brackets and tied with elastomers by figure of 8. During this stage, only tipping movement was applied.

Primary outcomes

  1. Pulpal blood flow changes by the use of Laser Doppler Flowmeter (Moor lab, Moor instruments, UK) with a wavelength of 780 nm and a dental probe MP 13 (Moor instruments, UK; 2 fibers, 0.25 mm diameter, centers 0.5 mm spaced apart).

    Time frame: 20 minutes ,48 hours, 72 hours and 1 month

    millimeter per second

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Dec 11, 2018
Registry last updated
Jan 2, 2019

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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