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临床试验/NCT07687329
NCT07687329已完成不适用

Comparison Of Efficiency And Treatment Duration Between Clear Aligners Manufactured Directly And Indirectly By The Clinician And Fixed Orthodontic Treatment: An In Vivo Randomized Clinical Trial

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Treatment Quality Assessed by the American Board of Orthodontics Objective Grading System (ABO-OGS)

研究概览

简要总结

Clear aligner therapy has become increasingly popular as an esthetic alternative to conventional braces in orthodontic treatment. While clear aligners are traditionally manufactured by commercial laboratories using a thermoforming technique, recent advances in 3D printing technology now allow clinicians to produce aligners directly in their own clinic, either by printing the aligner itself (direct method) or by printing a model and then thermoforming the aligner over it (indirect method)." "This study compares three approaches to orthodontic treatment in patients with mild to moderate dental crowding who do not require tooth extraction: clear aligners produced directly in-house using 3D printing with a shape-memory resin, clear aligners produced indirectly in-house using a 3D-printed model and thermoforming, and conventional fixed orthodontic treatment with metal brackets and wires." "A total of 36 patients aged 12 to 30 years were randomly assigned to one of these three treatment groups, and 33 patients completed the study. Treatment quality was evaluated using the American Board of Orthodontics Objective Grading System (ABO-OGS), an objective scoring method based on dental models obtained at the end of treatment. The total duration of treatment, from the start of active treatment to its completion, was also compared among the three groups." "The findings of this study may help clinicians and patients better understand the advantages and limitations of in-house clear aligner production compared to conventional fixed appliances, particularly regarding treatment efficiency and duration.

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
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of permanent dentition (no primary teeth remaining)
  • Non-extraction orthodontic treatment plan
  • Age between 12 and 30 years
  • Mild to moderate dental crowding (0-6 mm)
  • Skeletal Class I classification (ANB: 2±2°)
  • Normal vertical growth direction (Sn-GoGn: 32±6°)
  • No congenital tooth agenesis (excluding third molars)
  • No atypical tooth shapes
  • No extracted permanent teeth
  • No dental caries
  • Good oral hygiene
  • Healthy periodontal tissues

排除标准

  • Presence of craniofacial anomalies
  • Systemic disease or condition
  • Previous fixed orthodontic treatment
  • History of allergy to dental materials
  • History of xerostomia

结局指标

主要结局

Treatment Quality Assessed by the American Board of Orthodontics Objective Grading System (ABO-OGS)

时间窗: From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 months

Post-treatment dental models were evaluated using the ABO Objective Grading System, which scores eight criteria: tooth alignment, marginal ridge height, buccolingual inclination, overjet, occlusal contacts, occlusal relationships, interproximal contacts, and root angulation. Lower total scores indicate better treatment quality. Scores were classified as successful (\<20), borderline (20-30), or unsuccessful (\>30).

次要结局

  • Total Treatment Duration(From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmet Yağcı

PROF. DR.

TC Erciyes University

研究点 (1)

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