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临床试验/NCT06685029
NCT06685029已完成不适用

Comparison of Clear Aligner System Produced Directly by the Orthodontist and Indirect Clear Aligner Systems With Fixed Orthodontic Treatment in Terms of Endocrine Disrupting Monomer Release: In-vivo Randomized Controlled Clinical Study

Ahmet Yağcı1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Bisphenol A Concentration

研究概览

简要总结

The aim of this study is to evaluate the release of endocrine disrupting monomers from clear aligners as a result of exposure to intraoral factors by measuring their concentration in saliva and to evaluate their reliability of use in terms of general health by comparing them with the fixed orthodontic treatment group. It is also aimed to compare the groups in terms of treatment effectiveness and efficiency.

详细描述

The aim of our study is to evaluate the saliva concentration of endocrine-disrupting monomers released from attachments used and clear aligners produced directly by the orthodontist in the clinic and indirectly produced by companies. Accordingly comparing them with the fixed orthodontic treatment group and assessing clear aligner's safety for general health. It is also aimed to compare the groups in terms of treatment effectivenes and total time spent . Endocrine-disrupting chemicals are substances that interfere with the synthesis, metabolism, or effects of hormones, causing deviation from normal reproduction and homeostatic control in organisms. Bisphenol A (BPA), a monomer, is also included in the chemicals listed as endocrine disruptors by the World Health Organization. Different studies have suggested that Bisphenol A may cause adverse health effects by acting as an endocrine disruptor. While previous research has been conducted on BPA release or monomer leakage related to orthodontic materials, there is limited evidence regarding the safety aspects of thermoplastic aligners or retainers. The concentrations of endocrine-disrupting monomers in the saliva of patients undergoing treatment with directly produced aligners by orthodontists and indirectly produced aligners by companies will be examined in comparison to patients undergoing fixed orthodontic treatment. Patients will not receive any treatment other than routine orthodontic care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Absence of primary teeth in the oral cavity, with permanent teeth fully erupted,
  • •Presence of a non-extraction orthodontic treatment plan,
  • •Age range of 15 to 24 years,
  • •Presence of mild to moderate dental crowding (0-6 mm of crowding),
  • •Classification as skeletal Class I (ANB: 2±2°),
  • •Absence of any craniofacial anomalies,
  • •Normal vertical growth pattern (Sn-GoGn: 32±6°),
  • •No congenital tooth agenesis (excluding third molars),
  • •Absence of atypical tooth morphology,
  • •No extracted permanent teeth,
  • •Absence of dental caries,
  • •Good level of oral hygiene,
  • •Healthy periodontal tissues.

排除标准

  • •Presence of any systemic disease,
  • •History of previous fixed orthodontic treatment,
  • •History of allergy to any dental material,
  • •Use of medications containing estrogen analogs,
  • •Patients with a history of xerostomia and a salivary flow rate of less than 0.1 ml per minute,
  • •Patients with more than five composite restorations.

研究组 & 干预措施

Dİrect In-House Aligner Group

Experimental

Patients in this group are treated with clear aligners produced directly by the clinician. The physical model production step is eliminated with direct production technique.Intraoral scan images were obtained from these patients with the 3Shape TRIOS (3Shape, Copenhagen, Denmark) scanning device. Then, the 3D scan images were transferred to the Maestro 3D Dental Studio (New Age, Pisa, Italy) computer software. Using these scan images, the teeth were gradually moved according to the planned final treatment result. The number of clear paligners required is calculated by the program according to the total amount of planned tooth movement. Then, Tera Harz TC-85DAC (Graphy, Seoul, Korea) resin and Asiga MAX UV (Asiga, Sydney, Australia) 3D printer were used for the direct production of the plates designed in the program. The aligners produced were then delivered to the patients.

干预措施: Clear aligner treatment (Device)

Invisalign Group

Experimental

Intraoral scan images were obtained with the 3Shape TRIOS (3Shape, Copenhagen, Denmark) scanning device from patients who would receive Invisalign (Align Technology, Santa Clara, CA) clear aligners. These 3D intraoral scan images, together with the intraoral and extraoral photographs, radiographic records, and clinical examination findings obtained from the patients, were uploaded to the cloud software 'ClinCheck' for Invisalign . Necessary instructions were written regarding the patients' treatment plans. Afterwards, patient specific 3D treatment simulations sent to the clinician by the companies were reviewed and the necessary revisions were made. The final accepted treatment plan was approved and the aligners were produced by the relevant companies and sent to the clinic.The clear aligners produced are delivered to the patients and treatment started.

干预措施: Clear aligner treatment (Device)

ClearCorrect Group

Experimental

Intraoral scan images were obtained with the 3Shape TRIOS (3Shape, Copenhagen, Denmark) scanning device from patients who would receive Invisalign (Align Technology, Santa Clara, CA) and ClearCorrect (ClearCorrect®, Round Rock, TX, USA) clear aligners. These 3D intraoral scan images, together with the intraoral and extraoral photographs, radiographic records, and clinical examination findings obtained from the patients, were uploaded to the cloud software 'ClinCheck' for Invisalign . Necessary instructions were written regarding the patients' treatment plans. Afterwards, patient specific 3D treatment simulations sent to the clinician by the companies were reviewed and the necessary revisions were made. The final accepted treatment plan was approved and the aligners were produced by the relevant companies and sent to the clinic.The clear aligners produced are delivered to the patients and treatment started.

干预措施: Clear aligner treatment (Device)

Fixed Orthodontic Treatment Group

Experimental

In the fixed orthodontic treatment group, all tooth surfaces to which brackets would be bonded were etched with 37% phosphoric acid (dline Phosphoric Acid Etching Gel UAB, Medicinos linij Karaliauciaus str. 29 LT-78348 Siauliai Lithuania) for 30 seconds, then bond (3M Unitek Transbond XT, Minnesota, U.S.A.) was applied and light was applied to all teeth separately for 5 seconds with a light device (Valo Cordless curing light Ultradent Products, Inc. 505 W. Ultradent Drive (10200 South) South Jordan, UT 84095) [165, 166]. Afterwards, composite (3M Unitek Transbond XT, Minnesota, U.S.A.) was applied to the base of the metal brackets (AO Mini Master Roth 018, Altenhofstrasse 80, 66386 St. Ingbert, Germany) and after it was placed on the tooth surface and the composite residues around the bracket were cleaned, light was applied for 5 seconds for each bracket. Then, arch wires were applied and the fixed orthodontic treatment of the patients was started.

干预措施: Fixed Orthodontic Appliance Treatment (Device)

结局指标

主要结局

Bisphenol A Concentration

时间窗: up to 1 year

Bisphenol A concentration in patients' saliva is measured as ng/ml.

次要结局

  • Treatment Effectiveness (via PAR İndex)(up to 1 year)
  • Treatment efficiency(up to 1 year)

研究者

发起方
Ahmet Yağcı
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmet Yağcı

PROFESSOR

TC Erciyes University

研究点 (1)

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