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临床试验/NCT07397104
NCT07397104尚未招募不适用

Validity of a Self-Reported Questionnaire for Periodontal Status in a Saudi Population: A Cross-Sectional Clinical Validation Study

Universiti Sains Malaysia0 个研究点目标入组 291 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
291
主要终点
Diagnostic accuracy of the self-reported periodontal questionnaire for clinically determined periodontal status

研究概览

简要总结

This observational study will evaluate the accuracy of a self-reported periodontal questionnaire in adults attending screening appointments in Abha, Saudi Arabia. Participants will complete the questionnaire and then undergo a same-visit clinical periodontal examination. The study will compare questionnaire-based results with clinical examination findings to assess diagnostic accuracy and agreement.

详细描述

This observational, cross-sectional clinical validation study will assess the validity of a self-reported periodontal questionnaire (CDC-AAP self-report items) among adults attending scheduled screening appointments at Asir Specialized Dental Center in Abha, Saudi Arabia. At the screening visit, participants will complete the self-reported questionnaire. During the same visit, trained clinicians will perform a standardized full mouth clinical periodontal examination, which will serve as the reference standard for determining periodontal status and/or periodontal disease categories according to predefined clinical criteria in the study protocol.

The primary objective is to determine how accurately the self-reported questionnaire identifies clinically determined periodontal status. Questionnaire responses and any questionnaire-derived classification will be compared with clinical examination results to estimate diagnostic accuracy (e.g., sensitivity, specificity, and overall accuracy) and to assess agreement between questionnaire-based and clinically based classifications. Additional outcomes may include feasibility measures such as questionnaire completion rates and missing data patterns. Data will be recorded using study identifiers and stored in secure, access-controlled systems to protect confidentiality. Participation does not involve assignment to any treatment; it consists only of completing a questionnaire and undergoing a same-visit periodontal examination.

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

入选标准

  • Age 18 years or older
  • Able to provide informed consent
  • Able to complete the self-reported periodontal questionnaire
  • Willing to undergo a same-visit clinical periodontal examination

排除标准

  • Less than ten teeth present
  • Any condition that makes periodontal probing unsafe, as judged by the clinician according to local policy
  • Unable to complete study procedures or provide informed consent

研究组 & 干预措施

Adults attending screening appointments (self-report + same-visit clinical exam)

Participants scheduled for screening appointments at Asir Specialized Dental Center will complete a self-reported periodontal questionnaire (CDC-AAP items). During the same visit, a trained clinician will perform a standardized clinical periodontal examination to determine periodontal status (full mouth periodontal examination based on CDC/AAP and EFP case definitions). Questionnaire results will be compared with the clinical findings to evaluate validity.

干预措施: Self-reported periodontal questionnaire and clinical periodontal examination (reference standard) (Other)

结局指标

主要结局

Diagnostic accuracy of the self-reported periodontal questionnaire for clinically determined periodontal status

时间窗: Same-visit (baseline)

Accuracy of the self-reported periodontal questionnaire in identifying clinically determined periodontal status based on the same-visit clinical periodontal examination (reference standard). Diagnostic performance will be summarized using standard measures such as sensitivity, specificity, and area under the ROC curve, as applicable to the questionnaire-derived classification.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdulrahman Ahmed M. Alshehri

Principal Investigator

Universiti Sains Malaysia

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