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临床试验/NCT06447389
NCT06447389进行中(未招募)不适用

"Clinical Evaluation of Retraction Cord Effectiveness Using Direct Digitalization Method in Determining the Preparation Margin Line"

Hacettepe University2 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2022年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
32
试验地点
2
主要终点
Digital analysis

研究概览

简要总结

Dental-supported fixed partial dentures (FPDs) have long been a commonly preferred treatment method for the rehabilitation of teeth with excessive substance loss and for addressing existing tooth deficiencies. Crucial factor affecting the success and quality of FPDs is the marginal fit of the restoration. Marginal discrepancy refers to the vertical or horizontal gap between the restoration finish line and the preparation finish line. To achieve high marginal fit restorations, gingival retraction techniques are used with the aim of removing the marginal gingiva away from the finish line. Retraction cords are commonly used for this purpose nowadays. The aim of the study is to evaluate the effect of retraction cords on the preparation finish line and the marginal fit of produced restorations using direct digital measurement methods.

详细描述

This study is designed to produce temporary bridges based on two supporting teeth, fabricated using an intraoral scanner, and to evaluate the marginal fit of these bridges based on two different digital measurements obtained with and without the use of retraction cord on the patient.

The study will encompass patients with a single missing tooth in the posterior region of the lower or upper jaw, specifically involving the second premolar or first molar, planned for a three-unit tooth-supported fixed partial denture (SPP). Prior to preparation, patients will be examined for the assessment of the soft tissue around the teeth, and data collection will be conducted in accordance with the criteria outlined in Table-1, following the guidelines of the 2017 Consensus Report on the Classification of Periodontal and Peri-implant Diseases and Conditions regarding periodontal health and gingival diseases in healthy and reduced periodontium.

Subsequently, the abutment teeth will be prepared stepwise using high-speed rotary instruments and diamond preparation burs to accommodate fixed restorations.

The study groups will be formed considering the presence or absence of retraction application. The groups will be defined as Group I (No retraction cord) and Group II (Retraction cord present).

In Group I, digital impressions will be taken directly in all patients without placing a retraction cord.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

The investigator, who performed the statistical analysis, will not know which group the obtained primary and secondary data belong to until all evaluations are completed.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Voluntary participation after reading and understanding the informed consent form.
  • Over 18 years of age with no general health issues.
  • Presence of a single missing posterior tooth in the upper or lower jaw.
  • Possession of "clinical gingival health" in terms of periodontal condition ("Clinical gingival health of a healthy periodontium is defined as the absence of bleeding on probing, erythema, edema, symptoms, and no loss of bone or attachment.(17))
  • Teeth with less than half of the tooth structure lost that do not require post-core treatment.

排除标准

  • Failure to accept voluntary participation in the study after reading the informed consent form.
  • General health condition being unsuitable for prosthetic treatment.

结局指标

主要结局

Digital analysis

时间窗: 1.5 year

The comparison of the marginal fit of restorations fabricated from digital data with and without the use of a retraction cord was performed using reverse engineering software. The digital scans taken after preparation, the digital scans taken after restoration delivery, and the .stl files of the restorations were superimposed within the software and analyzed for marginal fit.

次要结局

  • Probing dept(1.5 year)

研究者

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

Kıvanç Akça

Prof. Dr.

Hacettepe University

研究点 (2)

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