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

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ClinicalTrials.gov Identifier: NCT03772795
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : January 2, 2019
Sponsor:
Information provided by (Responsible Party):
Elham Abu Alhaija, Jordan University of Science and Technology

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Alignment Other: Orthodontic Alignment Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups receiving 2 interventions. In the first group patients received fixed orthodontic appliance and in the second, they received clear aligner orthodontic appliance
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using Clear Aligners
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
Active Comparator: Group 1- Alignment with fixed appliance
A pre-adjusted edgewise fixed appliance (3M Gemini Uniteks, 0.022" Roth prescription brackets.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.
Other: Orthodontic Alignment
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.

Experimental: Group 2- Alignment with clear aligners
Clear aligner orthodontic appliance (EON, Eon Dental NV, Belgium). Teeth alignment with clear aligners.
Other: Orthodontic Alignment
Group 2: Teeth alignment using clear aligners.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Responsible Party: Elham Abu Alhaija, Principal Investigator - Main thesis supervisor, Jordan University of Science and Technology
ClinicalTrials.gov Identifier: NCT03772795    
Other Study ID Numbers: 262/2016
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: January 2, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elham Abu Alhaija, Jordan University of Science and Technology:
Pulpal blood flow
clear aligners
orthodontics