跳至主要内容
临床试验/NCT06006429
NCT06006429招募中不适用

Digital Extraction and Scientific Visualization of Clinical Characteristics From 3D Data From Intraoral Scanners for Dental and Periodontal Pathologies Research : Computer Formalization and Feasibility Study

CHU de Reims1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年5月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
CHU de Reims
入组人数
30
试验地点
1
主要终点
Recession measurement concordance (Ramfjord, 1959)

研究概览

简要总结

Periodontal diseases and dental pathologies are highly prevalent oral diseases. Thirty-three to fifty percent of adult population presented at least one untreated caries and more than 50% of French population are affected by severe periodontitis. These diseases affect dental organ or periodontal attached system but could have negative impact on general health, quality of life, word and individual well-being. Association between chronic diseases as diabetes, rheumatoid arthritis, cardiovascular diseases, and oral health have been well investigated. Dental and periodontal diagnosis is dependent of various clinical parameters time consuming and dependent operator. It represents a public health challenge. Informatic analysis detecting diseases could be a time gain and a more precise diagnosis tool. Today, any software or algorithm allow automatized detection, clinical qualitative or quantitative indices recording while these informations are present in numeric models

详细描述

The present study explores the effectiveness of intraoral scanners in the field of dental caries and periodontal diseases diagnosis Patients presenting at least on recession are recruited without randomization. A clinical examination is performed, and a 3D impression of their mouth is obtained by intraoral scanners.

The investigators hypothesized that the 3D intra oral representations could improve oral diagnosis in patients compared to clinical examination in term of time consummation and precision. In a first time, this could be achieved by the comparison of the recession measurement obtained by a clinical measure (Ramfjord, 1959) or obtained by artificial intelligence.

The secondary objectives are :

  • To compare clinical and numerical dento-prosthetic diagram
  • To compare clinical and numerical plaque control record index (O'Leary et al., 1973)
  • To compare clinical and numerical Decayed, Missed and Filled Teeth index (Klein and Palmer, 1940)
  • To compare clinical and numerical detection of mucosal lesions

研究设计

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

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

  • consulting the Dental Care Service of the university hospital of Reims
  • presenting at least one gingival recession
  • presenting at least 10 pairs of opposing teeth
  • speaking French
  • who signed the informed consent form
  • affiliated to the French Social Security system

排除标准

  • Patients presenting :
  • pregnancy or breastfeeding
  • orthodontic treatments
  • patients under legal protection, trusteeship or guardianship
  • unable to understand auto-questionnary

研究组 & 干预措施

Patients

Experimental

干预措施: Numerical dental impression by intraoral scanner (Other)

结局指标

主要结局

Recession measurement concordance (Ramfjord, 1959)

时间窗: Day 1

Recession depths is measured between the cementum-enamel junction and the edge of the marginal gingiva. The clinical and numerical scored will be compared.

次要结局

  • Dento-prosthetic diagram concordance(Day 1)
  • Mucosal lesions detection(Day 1)
  • Plaque Control Record Concordance (O'Leary et al., 1972)(Day 1)
  • Gingival Index Concordance (Loe and Silness, 1963)(Day 1)
  • Decayed, Missed and Filled Teeth Index (Klein and Palmer, 1940)(Day 1)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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