Pilot Study on the Accuracy of Masticatory Function Assessment to Discriminate Stage IV Periodontitis From Other Periodontitis Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
This is a pilot diagnostic accuracy study to assess the ability to discriminate in a screening context Stage IV periodontitis from other stages of periodontitis. The index test is the assessment of masticatory dysfunction performed with a questionnaire and a chewing gum test. The reference standard is a full periodontal and functional assessment performed by a trained and calibrated specialist.
详细描述
This is a pilot diagnostic accuracy study. Data are derived from a cross-sectional study based on a convenience, quota sample of patients referred for dental care to the reception clinic of the Prince Philip Dental Hospital or at the Institute of Advanced Dentistry, the University of Hong Kong between October 2020 and May 2021. The study will be conducted in accordance with the current revision of the Declaration of Helsinki. Informed consent will be obtained from all participants prior to enrollment in the study. This study will follow the Standards for Reporting Diagnostic Accuracy (STARD) guidelines. To limit bias, separate calibrated examiners performed the index test (chewing gum test) and the periodontal examination used for periodontitis stage and grade diagnosis (reference standard).
To evaluate the diagnostic accuracy of masticatory function assessment for Stage IV periodontitis, logistic regression analyses will be conducted in univariate analyses and the area under the receiver operating characteristic curve (AUROC), diagnostic odds ratios (DORs), sensitivity, specificity, positive predictive values and negative predictive values will be calculated.
Multivariate logistic regression models will be applied to develop a screening algorithm for Stage IV periodontitis diagnosis including the masticatory function assessment and other candidate predictors. A backward stepwise selection method will be used (p = 0.05 for inclusion in model; p = 0.05 for removal from model). The standard nomenclature for interpreting low, moderate and high levels of accuracy will be based on sensitivity and specificity as well as the AUROC values: low level = sensitivity or specificity <60%, AUROC ≤ 0.70; moderate level = sensitivity or specificity ranging from 60% to 79%, AUROC ranging from 0.71 to 0.90; high level = sensitivity or specificity ≥ 80%, AUROC>0.90
研究设计
- 研究类型
- 观察性
- 观察模型
- 仅病例
- 时间视角
- 横断面
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Periodontitis subjects reporting for care at reception clinic of dental hospital
排除标准
- presence of temporomandibular disorders,
- subjects undergoing orthodontic treatment
- less than 12 teeth;
- subjects having received periodontal treatment in the previous 12 months;
- subjects having received antibiotic medication in the previous 3 months
结局指标
主要结局
Diagnostic accuracy
时间窗: Baseline
Area under the receiver operating curve (AUROC)
次要结局
未报告次要终点
研究者
研究点 (2)
标识符
- NCT 编号
- NCT05202132
- 其他研究编号
- UW20-637
日期
- 首次提交
- (4年前)
- 首次发布
- (4年前)
- 主要完成日期
- (5年前)
- 研究完成日期
- (5年前)
- 最近核实
- 最近更新
- (4年前)
监管与共享
- FDA 监管药物
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
