Use of a Tissue Autofluorescence Detection System for Identification of Oral Mucosal Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Fluorescence change of oral mucosa
研究概览
简要总结
The aim of the study will be to evaluate the efficacy of a tissue autofluorescence detection system as an aid to clinical screening in identifying lesions of the oral mucosa. The screening process will be performed by 3 clinicians with a different level of experience. Sensitivity and specificity tests will be conducted.
详细描述
Tissue autofluorescence analysis will be performed using GOOCLES® glasses, a device capable of detecting variations in fluorescence when the examined area is illuminated with a common photopolymerising lamp. Three clinical professionals will be identified:
- Dental hygienist (1);
- General dentist (2);
- Dentist expert in Medicine and Oral Pathology (3).
All patients will be included in the study after receiving an initial dental visit, in order to rule out patients with noticeable oral lesions.
Dental hygienist (1) will collect the patient's data by filling the "anamnestic record". Furthermore, (1) will perform the first clinical examination (with and without GOOCLES®), reporting his observations on his own "operator module".
The same screening (with and without GOOCLES®) will be conducted blindly by the general dentist (2) who, if he deems it necessary, will refer the patient to the oral pathologist (3), who will confirm or not (with and without GOOCLES®) the presence of an oral region such as to be further investigated (follow up or biopsy) and will report the observations on its own "operator module".
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female;
- •Age ≥ 18 years;
- •Non-smokers and smokers
排除标准
- •Cancer patients;
- •Patients presenting a histological diagnosis of oral mucosal dysplasia/carcinoma.
研究组 & 干预措施
Screening examination
All patients will undergo a screening examination (with or without GOCCLES ® glasses) by all three operators.
干预措施: Screening examination (Device)
结局指标
主要结局
Fluorescence change of oral mucosa
时间窗: baseline and after 21 day
Presence of a mucosal area with reduced or increased fluorescence
Clinical change of oral mucosa
时间窗: baseline and after 21 days
Presence of a white, red, or mixed mucosal area with an exophytic or vegetative appearance or with loss of substance
次要结局
未报告次要终点
研究者
Luca Ramaglia
Clinical Professor
Federico II University