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

Tooth Crowding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04678596
• Other study ID #: TDH-2017-7774
• Status: Completed
• Phase: N/A
• Start date: December 6, 2017
• Est. completion date: December 6, 2019

Study information

• Verified date: December 2020
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 6, 2019
• Est. primary completion date: May 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Malocclusion
• Tooth Crowding
• Tooth; Lesion, White Spot Lesions

Intervention

Device:
• EonAligner
EonAligner system is one stage system.
• Clearfix
Clearfix system is three-stage system.

Locations

Country	Name	City	State
Turkey	Erciyes University, Faculty of Dentistry, Department of Orthodontics University university	Kayseri	Melikgazi

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of white spot lesion formation	rate of new white spot formation	2 years
Other	Change of pain during treatment	measurement of pain level (grading system, VAS scoring)	2 years
Primary	Aesthetic and comfortable orthodontic treatment with aligner systems	Surveys	2 years
Primary	Comfortable orthodontic treatment with aligner systems	Visual Analog Score for pain	2 years
Secondary	Quality of life at orthodontic treatment with aligner systems	Physicians Global Assessment to measure quality of life	2 years
Secondary	Evaluation of white spot lesion formation	rate of new white spot formation	2 years