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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-04-01

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).

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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.

Conditions

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Alignment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Orthodontic Alignment

Intervention Type OTHER

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.

Group 2- Alignment with clear aligners

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

Group Type EXPERIMENTAL

Orthodontic Alignment

Intervention Type OTHER

Group 2: Teeth alignment using clear aligners.

Interventions

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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.

Intervention Type OTHER

Orthodontic Alignment

Group 2: Teeth alignment using clear aligners.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Both male and female subjects
* 16 or more years old
* Class I skeletal malocclusion

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes