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).

Study Overview

• Status: Completed
• Conditions: Alignment
• Intervention / Treatment: Other: Orthodontic Alignment; Other: Orthodontic Alignment

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 22 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.; Other: Orthodontic Alignment; Group 2: Teeth alignment using clear aligners.
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 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.; Other: Orthodontic Alignment; Group 2: Teeth alignment using clear aligners.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	millimeter per second	20 minutes ,48 hours, 72 hours and 1 month

Collaborators and Investigators

• Sponsor: Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: December 1, 2018
• First Submitted That Met QC Criteria: December 9, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 28, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: orthodontics; Pulpal blood flow; clear aligners
• Other Study ID Numbers: 262/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No