NCT07397104

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 291 (estimated)
• Sponsor: Universiti Sains Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Periodontal Diseases
• Periodontitis
• Gingivitis

Interventions

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

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-08-29
• Completion: 2026-10-29
• First posted: 2026-02-09
• Last updated: 2026-02-11