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

NCT07397104 | Not Yet Recruiting DMC

• 1 other identifier: F3-12-2025
• Study Type: observational
• Target: 291
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Periodontal Diseases; Periodontitis; Gingivitis

Keywords

Periodontal disease; Validity; self-reported

Outcome Measures

Primary Outcomes (1)

• 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.

  Same-visit (baseline)

Study Arms (1)

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

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be selected from adults scheduled for dental screening appointments at Asir Specialized Dental Center, Abha, Saudi Arabia. Recruitment and all study procedures will take place at the center during the scheduled screening visit.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Ministry of Health, Saudi Arabia: collaborator

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Gingivitis

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Central Study Contacts

Abdulrahman Ahmed Alshehri, MS

CONTACT

00966507090251; alshehriabdulrahman3@student.usm.my

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): October 29, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified IPD and supporting documents will be available beginning 12 months after publication of the primary results (or 12 months after study completion if not published) and will remain available for 5 years thereafter.
• Access Criteria: Access will be provided to qualified researchers who submit a methodologically sound proposal (protocol/analysis plan) and obtain any required ethics approval/exemption. Approved requestors will receive de-identified participant-level data (questionnaire responses and clinical periodontal status) and selected supporting documents under a data use agreement, shared via secure transfer. No direct identifiers will be shared.