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

Alignment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772795
• Other study ID #: 262/2016
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: December 2018
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 1, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Alignment

Intervention

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.
• Orthodontic Alignment
Group 2: Teeth alignment using clear aligners.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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