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

N/ANot Yet RecruitingNCT07397104

Universiti Sains Malaysia291 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

291

Conditions

Periodontal Diseases Periodontitis Gingivitis

Interventions

Self-reported periodontal questionnaire and clinical periodontal examination (reference standard)OTHER

Data collection procedures to validate questionnaire-based periodontal status; no therapeutic intervention is assigned.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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

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.

Time frame: Same-visit (baseline)

Central Contacts

Abdulrahman Ahmed Alshehri, MS

CONTACT

00966507090251 alshehriabdulrahman3@student.usm.my

Data from ClinicalTrials.gov

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