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

Jordan University of Science and Technology

Status: Completed

Conditions: Alignment

Treatments: Other: Orthodontic Alignment

Study type: Interventional

Funder types: Other

Identifiers

NCT03772795

262/2016

Details and patient eligibility

About

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).

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 16 to 22 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Group 1- Alignment with fixed appliance

Active Comparator group

Description:

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.

Treatment:

Other: Orthodontic Alignment

Other: Orthodontic Alignment

Group 2- Alignment with clear aligners

Experimental group

Description:

Clear aligner orthodontic appliance (EON, Eon Dental NV, Belgium). Teeth alignment with clear aligners.

Treatment:

Other: Orthodontic Alignment

Other: Orthodontic Alignment