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

Universiti Sains Malaysia

Status: Not yet enrolling

Conditions: Periodontitis; Periodontal Diseases; Gingivitis

Treatments: Other: Self-reported periodontal questionnaire and clinical periodontal examination (reference standard)

Study type: Observational

Funder types: Other

Identifiers

NCT07397104

F3-12-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 291 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

291 participants in 1 patient group

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

Description:

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.

Treatment:

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