Clinical trial NCT04678596: Comparison Of Different Orthodontic Aligner Systems Applied On Single Stage And Three Stage
Official title: Comparison Of Different Orthodontic Aligner Systems Applied On Single Stage And Three Stage In Terms Of Comfort, Satisfaction, Treatment Effects And Duration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Crowding
Tooth; Lesion, White Spot Lesions
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Aesthetic and comfortable orthodontic treatment with aligner systems
timeFrame: 2 years
measure: Comfortable orthodontic treatment with aligner systems
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life at orthodontic treatment with aligner systems
timeFrame: 2 years
measure: Evaluation of white spot lesion formation
timeFrame: 2 years
Other outcomes:
measure: Evaluation of white spot lesion formation
timeFrame: 2 years
measure: Change of pain during treatment
timeFrame: 2 years
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University, Faculty of Dentistry, Department of Orthodontics University university
state: Melikgazi
Study officials:
affiliation: Erciyes University Faculty of Dentistry
name: meltem özsaygılı, Research Ass
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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.