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临床试验/NCT04845581
NCT04845581已完成不适用

Comparison of the Effectiveness of the Ultrasonic Method and Cone-beam Computed Tomography Combined With Intraoral Scanning and Prosthetic-driven Implant Planning Method in Determing the Gingival Phenotype in the Healthy Periodontium.

Wroclaw Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Determination the gingival phenotype

研究概览

简要总结

Compare two diagnostic methods: UGTM and CBCT/CAD/PDIP in determing the gingival phenotype in group of 30 periodontally healthy patients. Both methods were useful to establishing the gingival phenotype, however, ultrasonic method was more precisely for measurement of gingival thickness. There was positive correlation between the mean values of SGT and WKT and this indicates the need to measure these parameters in order to determine gingival phenotype.

详细描述

Gingival phenotype (GP) should be determine in each dento-gingival unit as a 3D volume of gingiva with the following parameters: width of keratinized tissue (WKT) and gingival thickness (GT). The phenotype determination is extremely important during many dental procedures, such as in dental surgery, orthodontics, prosthetics or implantology because it allows to dental treatment planning and reduce the risk of complications. Previous methods of determining the gingival phenotype were based on the shape of the crowns of the upper incisors and transparency of the free gingiva. These methods are non-invasive, but innacurate. The gingival phenotype may be determined more precisely by using biometry of WKT and GT. There are several possible methods to measure the thickness of the gingiva, such as bone sounding, cone beam comuted tomography (CBCT) measurement or parallel profile radiographs, CBCT/CAD (CBCT and computer-aided design) and ultrasound method. The ultrasonic gingival tissue measurement (UGTM) method is non-invasive, removes the need for anesthesia, which may increases the volume of tissues, but requires the experience of the researcher. However, it is considered as effective and reproducible method of the measurement soft tissue thickness. CBCT/CAD/PDIP (CBCT/CAD and prosthetic-driven implant planning) method also can be used to establishing the gingival phenotype.

Measurements of WKT are most often carried out using a periodontal probe calibrated every 1mm. In each case, a necessary condition for the proper examination of the patient and determination of GP is healthy periodontium.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
24 Years 至 54 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •lack of general diseases
  • •good oral hygiene
  • •healthy periodontium - API ratio<15%, BOP<10%
  • •no loss of clinical attachment in the examined areas (CAL=0)
  • •no use of drugs
  • •no addictions, especially cigarette smoking
  • •no use of mobile prosthetic restorations and orthodontic appliances
  • •no contraindications for X-ray examinations

排除标准

  • •general diseases
  • •poor oral hygiene
  • •non healthy periodontium - API ratio>15%, BOP>10%
  • •loss of clinical attachment in the examined areas (CAL>1)
  • •use of drugs that could influence the structure of the periodontal tissues
  • •addictions, especially nicotinism
  • •use of mobile prosthetic restorations and orthodontic appliances
  • •contraindications for X-ray examinations

结局指标

主要结局

Determination the gingival phenotype

时间窗: october 2018 to august 2019

The UGTM and CBCT/CAD/PDIP methods are useful to determining of gingival phenotype but more accurate and repeatability is UGTM. The presence of a positive correlation between SGT and WKT indicates the need to measured these parameters for the evaluation of GP. T. It is very important to determine the gingival phenotype for each dento-gingival unit especially before complicated dental treatment.

次要结局

未报告次要终点

研究者

发起方
Wroclaw Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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