Validity of a Self-reported Questionnaire for Periodontal Status in a Saudi Population

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Self-reported periodontal questionnaire and clinical periodontal examination (reference standard)
  Data collection procedures to validate questionnaire-based periodontal status; no therapeutic intervention is assigned.

Первичные конечные точки

• Diagnostic accuracy of the self-reported periodontal questionnaire for clinically determined periodontal status [Срок оценки: Same-visit (baseline)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07397104 · F3-12-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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