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Completed

NCT Number: NCT03780764

Changes in Pulpal Blood Flow Between Conventional and Self-ligating Fixed Orthodontic Brackets During Leveling and Alignment Stage

- Evaluate and compare initial changes in PBF between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage using 0.016" Nickle titanium (NiTi) and 0.016X0.022" NiTi archwires at different time intervals (20min, 24h, 72h, 1 week and 1 month) of initial arch wire placement.

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Key information

Conditions

Orthodontic Appliances

Age range

16 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of science and technology Dental Teaching Clinics

Irbid, Jordan

About this study

Objectives: to evaluate and compare the initial changes in pulpal blood flow (PBF) between conventional and self-ligating fixed orthodontic brackets during leveling and alignment stage.

Materials and Methods: A total of 22 patients (16 females and 6 males) aged 19± 2.53 years who presented with mild lower arch crowding were selected to participate in the study. A split mouth study design was applied for each patient. Two different fixed appliance brackets were used in the lower arch (self-ligating brackets on one side and conventional brackets on the other side of the same patients). PBF was measured for the lower right and left sides using Laser Doppler Flowmetry at different time intervals (20min, 24h, 72h, 1 week and 1 month) after the fitting of 2 alignment archwires; 0.016" NiTi and 0.016X0.022" NiTi. A repeated measures analysis of variance test and a Bonferroni post-hoc comparison test were applied to detect differences in PBF between the 2 groups.

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
  • 6 or more years old
  • Class I skeletal malocclusion
  • mild lower arch 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 and
  • smoking

Treatment and study plan

A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022" Roth prescription brackets

Other

A pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022" Roth prescription brackets) on one side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016" NiTi arch wire until 0.016X0.022" NiTi was reached. The NiTi arch wires were placed into brackets slots and tied with elastomers (figure of 8).

Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets

Other

Self-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022" Roth prescription brackets) on the other side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016" NiTi arch wire until 0.016X0.022" NiTi was reached. The NiTi arch wires were placed into brackets slots and held in place by bracket's gate in the self-ligating brackets side.

Primary outcomes

  1. Pulpal blood flow changes by the use of Laser Doppler Flowmeter

    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

Official study title

Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using 2 Fixed Orthodontic Appliances

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Dec 19, 2018
Registry last updated
Dec 20, 2018

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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