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Not yet recruiting NCT07397104

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

Observational Periodontal Diseases Periodontitis Gingivitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-reported periodontal questionnaire and clinical periodontal examination (reference standard).
Who it may be relevant to
Registry conditions: Periodontal Diseases, Periodontitis, Gingivitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

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.

Interventions

  • 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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07397104 · F3-12-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗