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

Not Applicable

Completed

• Conditions: Tooth; Lesion, White Spot Lesions; Tooth Crowding
• Interventions: Device: Clearfix; Device: EonAligner

• Registration Number: NCT04678596
• Lead Sponsor: TC Erciyes University

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-12-06
• Primary Completion: 2018-05-10
• Study First Submitted: 2019-09-30
• Study Completion: 2019-12-06
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-16
• Last Update Submitted: 2020-12-16
• Study First Posted: 2020-12-22
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clearfix	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.
EonAligner	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.

Primary Outcome Measures

Name	Time	Method
Comfortable orthodontic treatment with aligner systems	2 years	Visual Analog Score for pain
Aesthetic and comfortable orthodontic treatment with aligner systems	2 years	Surveys

Secondary Outcome Measures

Name	Time	Method
Quality of life at orthodontic treatment with aligner systems	2 years	Physicians Global Assessment to measure quality of life
Evaluation of white spot lesion formation	2 years	rate of new white spot formation

Trial Locations

Locations (1)

Erciyes University, Faculty of Dentistry, Department of Orthodontics University university; 🇹🇷 Kayseri, Melikgazi, Turkey