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临床试验/NCT06387992
NCT06387992尚未招募不适用

Evaluation of the Agreement Between a Consultation With a Nurse Acquiring Three-dimensional Intraoral Images Made With a 3D Intraoral Camera and the Standard Consultation With a Dental Surgeon, in Institutionalized Elderly Subjects

CHU de Reims1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
CHU de Reims
入组人数
50
试验地点
1
主要终点
DMFT index

研究概览

简要总结

The primary objective of this study will be to assess the agreement between a dental consultation with a nurse acquiring intraoral images, using a 3D intraoral camera, and a standard consultation with a dental surgeon, in institutionalized elderly subjects Institutionalized subjects planned to have a dental consultation and eligible will be included once written informed consent is signed. Their dental consultation will start with a consultation with a nurse to record 3D intraoral images, then a consultation with a dental surgeon for standard dental care, blinded from the nurse consultation will be performed. Thereafter, 3D images will be analyzed by another dental surgeon blinded from the results of both consultations. Agreement on different outcomes between the analysis of the images acquired by the nurse and the standard dental evaluation by a dental surgeon will be assessed.

Agreement on the results between the interpretation of the 3D images acquired by a nurse and the standard consultation by a dental surgeon could lead, in the long term, to a significant step forward in dental care of institutionalized patients.

Indeed, training nursing home nurses to acquire 3D dental images would enable the identification of patients in need of immediate dental care and thus extend the possibilities of access to consultations with a dentist for these patients. This would increase the efficiency of care.

详细描述

Participation in the study will be offered to any eligible patient in his nursing home prior to his dental consultation. If the patient agrees to participate in the research, he will be included in the study after signing informed consent.

For the included patients, one dental consultation will be planned and organized within the Oral Medicine Unit of the Reims University Hospital. The consultation will be divided into 3 different parts (2 consultations + images analysis):

  • 1st part: a consultation with a trained nurse who will perform a three-dimensional dental acquisition using a 3D intraoral camera and who will help the patient complete the General Oral Health Assessment Index (GOHAI)
  • 2nd part: a consultation with a dental surgeon, different from the one who analyzes the images. He will perform a standard dental consultation, blinded to the results of the nurse dental consultation.
  • 3rd part (without the patient): the three-dimensional images will be interpreted by a dental surgeon (the same for all patients included) blinded to the results of the consultations, in order to obtain the evaluation of the different outcomes. This last step will not require the presence of the patient and can be carried out later.

Participation in the study will not change the patient's dental care.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

DMFT index

时间窗: Day 1

During dental consultation with a dental surgeon and during the analysis of the 3D images DMFT index (Klein and Palmer, 1940). The index will be assessed from the 3D intraoral images acquired during the nurse consultation and from the standard dental consultation performed by a dental surgeon. The DMFT index describes, excluding third molars, the number of teeth: * D : Decayed * M : missing * FT : Filled Teeth The score represents the sum of missing, decayed and/or filled teeth in the same individual. Third molars are not taken into account in the calculation of this score.

次要结局

  • Plaque control record(Day 1)
  • General Oral Health Assessment Index (GOHAI)(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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