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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alignment

Intervention / Treatment
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* Other: Orthodontic Alignment
* Other: Orthodontic Alignment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1- Alignment with fixed appliance<br>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<br>* 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.<br>|
| Experimental: Group 2- Alignment with clear aligners<br>Clear aligner orthodontic appliance (EON, Eon Dental NV, Belgium). Teeth alignment with clear aligners. | Other: Orthodontic Alignment<br>* Group 2: Teeth alignment using clear aligners.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpal blood flow, clear aligners, orthodontics