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

Comparison Of Different Orthodontic Aligner Systems Applied On Single Stage And Three Stage In Terms Of Comfort, Satisfaction, Treatment Effects And Duration

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.

Study Overview

• Status: Completed
• Conditions: Tooth; Lesion, White Spot Lesions; Tooth Crowding
• Intervention / Treatment: Device: EonAligner; Device: Clearfix

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Melikgazi
    • Kayseri, Melikgazi, Turkey, 38039
      • Erciyes University, Faculty of Dentistry, Department of Orthodontics University university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 26 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: EonAligner; EonAligner system is one stage system.
Active Comparator: 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.	Device: Clearfix; Clearfix system is three-stage system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aesthetic and comfortable orthodontic treatment with aligner systems	Surveys	2 years
Comfortable orthodontic treatment with aligner systems	Visual Analog Score for pain	2 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of white spot lesion formation	rate of new white spot formation	2 years
Change of pain during treatment	measurement of pain level (grading system, VAS scoring)	2 years

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Study Chair: meltem özsaygılı, Research Ass, Erciyes University Faculty of Dentistry

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2017
• Primary Completion (Actual): May 10, 2018
• Study Completion (Actual): December 6, 2019

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: TDH-2017-7774

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No