Diagnostic Efficacy Assessment of Two Oral Telemedicine Tools Compared to Intra Oral Clinical Examination Used as a Reference: a Pilot Study in Region Grand-Est
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Detection of at least one decayed tooth in the mouth of each elderly of the study
研究概览
简要总结
This study is about the assessment of two oral telemedecine tools compared to an intra oral clinical examination used as a reference among elderly persons living in nursing home. Our hyposthesis is that the diagnostic performance of the two devices will be similar.
The main goal of the study is to assess the performances of two intra-oral cameras compared to an intra oral clinical examination to detect at least one decayed tooth.
The secondary objectives of this study are :
At patient's level:
- To assess the performances of two intra-oral cameras types compared to an intra oral clinical examination for detecting each of the following conditions: (i) at least one filled tooth, (ii) at least one missing tooth, (iii) gingivitis, (iv) an abscess, (v) dental plaque and (vi) calculous
- To assess the concordance between each intra oral cameras and the intra oral clinical examination in the evaluation of the number (i) of decayed teeth, (ii) filled teeth and (iii) missing tooth
- From video acquisitions of each intra oral cameras, to assess the inter-observer concordance for the diagnostic of each dental pathologies (presence of at least one decayed tooth, filled or missing) and periodontal (presence of gingivitis, abscess, dental plaque or scale)
- From video acquisitions of each intra oral cameras, to assess the inter-observer agreement of the number of teeth: (i) decayed, (ii) filled and (ii) missing
At tooth level : 5. To assess the performances of two intra-oral cameras types compared to an intra oral clinical examination for detecting each of the following conditions: (i) a cavity, (ii) a filled tooth and (iii) missing tooth
In all patients : 6. To assess patient's feelings about the use of each intra oral cameras 7. To compare the time required for video acquisitions between each of intra oral cameras
For patients with dental or periodontal pathologies observed during the intra oral examination:
8 To assess, 2 months after initial evaluation, the proportion of patients attended dental or periodontal care and for which an appointment with a dentist has been scheduled
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be an adult person
- •Be affiliated of granted of health insurance
- •Be resident of a nursing home
- •People (or the guardian) who received complete information about the research and who signed the consent form.
排除标准
- •People deprived of their liberty by justice's decision, or people following psychiatric treatment according to articles L. 3212-1 et L. 3213-1 of the French law
- •People with insufficient skills in French
- •People with total bimaxillary prosthesis
- •People without any teeth
结局指标
主要结局
Detection of at least one decayed tooth in the mouth of each elderly of the study
时间窗: within 2 weeks
* During the intra-oral examination (reference investigation) * Using video records of first camera told Soprocare® * Using video records of second camea told "wide public"
次要结局
- Conditions of the elderlies of the study will be evaluated thanks to the intra oral clinical examination and the video records of each of the two cameras.(within 2 weeks)
- The number of decayed, filled, missing teeth in the elderly of the study will be recorded thanks to the intra oral clinical examination and the video records of each of the two cameras.(within 2 weeks)
- Presence of each dental conditions (at least one tooth decayed, filled, missing) and each periodontal conditions will be assess by to independent reviewers from video records of each camera.(within 2 weeks)
- Number of teeth showing each dental conditions (at least one tooth decayed, filled, missing) will be assess by two independent reviewers from video records of each camera.(within 2 weeks)
- Presence of a decayed, a filled, or missing tooth, will be assess for each tooth of elderly of the study during the clinical examination and the records of each camera.(within 2 weeks)
- Feeling of the patient will be evaluated thanks to a questionnaire "questionnaire of acceptability of patient's examination"(within 2 weeks)
- Number of decayed, filled, missing teeth in the elderly of the study will be recorded thanks to the intra oral clinical examination and the video records of each of the two cameras.(within 2 weeks)
- Number of appointment programation(within 2 weeks)
研究者
Dr. Céline CLEMENT
Head of Dental Public Health Department
Central Hospital, Nancy, France