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NCT Number: NCT07397104

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdulrahman Ahmed Alshehri, MS

CONTACT

[email protected]

00966507090251

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Collaborators

  • Ministry of Health, Saudi Arabia

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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