Sviluppo, Validazione e Determinazione Della Accuratezza Diagnostica di un Questionario Per lo Screening di Parodontite
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 495
- 主要终点
- Specificity
研究概览
简要总结
The present study aims at validating the Italian version of one of the most widely used epidemiological questionnaires for periodontitis screening: the CDC/AAP questionnaire [hereafter referred to as the CDC/AAP_ITA questionnaire].
The study also aims to develop a modified version of the CDC/AAP questionnaire, enriched with additional questions, and to evaluate its diagnostic accuracy [hereafter referred to as the QSIdP questionnaire].
The study will be conducted at the Unità Complessa di Odontoiatria, Azienda Unità Sanitaria Locale (A.U.S.L.) of Ferrara (Director: Prof. Leonardo Trombelli), in collaboration with nine (9) other Italian clinical centers.
详细描述
The present multicenter cross-sectional clinical study aims at validateing the Italian version of one of the most widely used epidemiological questionnaires for periodontitis screening: the CDC/AAP questionnaire [hereafter referred to as CDC/AAP_ITA]. Furthermore, the study aims at developing a modified version of the CDC/AAP_ITA questionnaire, enriched with additional questions, and to assess its diagnostic accuracy [hereafter referred to as QSIdP].
All procedures included in the study protocol will be conducted in full compliance with the latest version of the Declaration of Helsinki. Participation in the study will require the signing of an informed consent form by each enrolled participant. In addition, the study will adhere to the STARD (Standards for Reporting Diagnostic Accuracy) guidelines.
Following development and validation, the CDC/AAP_ITA questionnaire (consisting of 8 questions) and the QSIdP questionnaire (consisting of 10 questions) will be administered to 495 patients with heterogeneous periodontal conditions recruited from ten Italian university clinical centers and/or public health facilities. Among these, Unità Complessa di Odontoiatria, Azienda Unità Sanitaria Locale (A.U.S.L.) of Ferrara (Director: Prof. Leonardo Trombelli), will be the Coordinating Center.
Within each center, patients will be enrolled according to specific inclusion criteria (i.e., age ≥18 years, ability to read and understand Italian, willingness to participate in the study) and exclusion criteria (i.e., completely edentulous individuals, subjects who have taken antibiotics within the past 3 months, pregnant women, or individuals with contraindications to periodontal probing).
Patient selection will take place during their stay in the waiting area of each participating clinical center, regardless of their chief complaint. Therefore, the questionnaires will be administered to all first-visit patients (and not exclusively to those seeking periodontal assessment).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥18 years;
- •ability to read and understand Italian;
- •willingness to participate in the study
排除标准
- •completely edentulous individuals;
- •subjects who have taken antibiotics within the past 3 months;
- •pregnant women;
- •individuals with contraindications to periodontal probing
研究组 & 干预措施
Patients receiving "CDC/AAP_ITA" and "QSIdP" questionnaire
Patients enrolled in the study (and belonging the unique examined study group) will receive the "CDC/AAP_ITA" and "QSIdP" questionnaires while waiting in the waiting room of one of the Clinical Centers. They will be instructed to complete the questionnaires independently and without assistance.
结局指标
主要结局
Specificity
时间窗: baseline visit
questionnaire ability to correctly reject healthy patients without a condition
sensitivity
时间窗: baseline vist
questionnaire ability to correctly detect ill patients out of those who do have the condition
次要结局
未报告次要终点
研究者
Prof. Leonardo Trombelli
full professor
Azienda Unità Sanitaria Locale (A.U.S.L.) Ferrara, Italy