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Comparison Of Different Orthodontic Aligner Systems Applied On Single Stage And Three Stage

NCT ID: NCT04678596

Last Updated: 2020-12-22

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-06

Study Completion Date

2019-12-06

Brief Summary

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Applying to the Orthodontics Department of the Faculty of Dentistry of Erciyes University for orthodontic treatment, a periodontally healthy 16-26 year-old periodontally healthy, non-congenital or congenital anomaly in the craniofacial region; 25 patients with class 1 orthodontic malocclusion with moderate permeability will be included in the study. The patients will be divided into 2 groups, and the first group of 12 patients will have single-stage aligner; The second group of 13 patients is planned to apply 3-stage aligner.

Detailed Description

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It is planned to take lateral cephalometric radiography, panoramic radiography before and after the orthodontic treatment, and in addition to orthodontic model and photograph records before, during and after the treatment. Patient comfort and satisfaction will be evaluated by applying questionnaires to patients before treatment, immediately after starting treatment, 2 days later, 1 week later, 1 month later, 1 week before and after the treatment, and the effects of 2 different treatment methods on the patients will be evaluated according to the data obtained. QLF recordings are also taken at the beginning of treatment and at 3-month intervals, and the effects of single plaque use and 3 different plaque use on white spot lesion formation will be evaluated.

Hays Nance analysis will be used in the orthodontic models to determine the change in the amount of perplexity. In this way, tooth movement speeds can be determined. There are studies in the literature with single-stage transparent plates, but there are no studies with different-stage plates. In our study, which of the two different types of treatment is more comfortable on patients and affects the movement of teeth faster; In addition, the investigators plan to investigate which one has a low risk of white spot lesions on the teeth.

Conditions

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Tooth Crowding Tooth; Lesion, White Spot Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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EonAligner

Patients in the EonAligner group were given a single thickness and hardness aligner and were asked to use the same it for 3 weeks.

Group Type ACTIVE_COMPARATOR

EonAligner

Intervention Type DEVICE

EonAligner system is one stage system.

Clearfix

In the Clearfix group, the patients were given three different thickness and hardness aligner and they were asked to use each aligner for one week from soft to hard.

Group Type ACTIVE_COMPARATOR

Clearfix

Intervention Type DEVICE

Clearfix system is three-stage system.

Interventions

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EonAligner

EonAligner system is one stage system.

Intervention Type DEVICE

Clearfix

Clearfix system is three-stage system.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* No systemic disease
* Being healthy as periodontal.
* No smoking.
* No previous orthodontic treatment.
* Lack of congenital tooth deficiency
* Permanent dentition
* Class 1 malocclusion
* No clefts
* No extracted teeth

Exclusion Criteria

* Orthodontic treatment history
* Missing tooth
* Poor oral hygiene
* Lack of cooperation
Minimum Eligible Age

16 Years

Maximum Eligible Age

26 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Yağcı

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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meltem özsaygılı, Research Ass

Role: STUDY_CHAIR

Erciyes University Faculty of Dentistry

Locations

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Erciyes University, Faculty of Dentistry, Department of Orthodontics University university

Kayseri, Melikgazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Yagci A, Korkmaz YN, Buyuk SK, Yagci F, Atilla AO. White spot lesion formation after treatment with full-coverage rapid maxillary expanders. Am J Orthod Dentofacial Orthop. 2016 Mar;149(3):331-8. doi: 10.1016/j.ajodo.2015.08.015.

Reference Type BACKGROUND
PMID: 26926020 (View on PubMed)

Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.

Reference Type BACKGROUND
PMID: 21208070 (View on PubMed)

Kim TW, Echarri P. Clear aligner: an efficient, esthetic, and comfortable option for an adult patient. World J Orthod. 2007 Spring;8(1):13-8.

Reference Type RESULT
PMID: 17373221 (View on PubMed)

Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.

Reference Type RESULT
PMID: 6758594 (View on PubMed)

Other Identifiers

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TDH-2017-7774

Identifier Type: -

Identifier Source: org_study_id