Clinical trial NCT03772795: Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using Clear Aligners
Official title: Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using Clear Aligners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alignment
Keywords: Pulpal blood flow
clear aligners
orthodontics
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: 20 minutes ,48 hours, 72 hours and 1 month
Secondary outcomes:
Other outcomes:
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Study officials:
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