Development of A Self-Assessment Tool for Personalized Preventive Periodontal Care Among the Saudi Population Using Semi-Supervised Learning

NCT07410351 | Recruiting DMC

• 1 other identifier: USM/JEPeM/KK/25050469
• Study Type: observational
• Target: 393
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study will collect labeled data to assess the accuracy of an online periodontal self-assessment tool in adults. Participants will complete the questionnaire and then undergo a clinical periodontal examination during the same visit. The study will compare questionnaire-based results with clinical examination results to evaluate diagnostic accuracy and agreement.

Conditions

Periodontal Diseases; Periodontitis; Gingivitis

Keywords

Periodontal diseases; risk assessment; self-report

Outcome Measures

Primary Outcomes (4)

• Agreement between self-assessment risk category and clinical periodontal risk category

  Agreement between the questionnaire-derived periodontal risk category and the reference-standard clinical periodontal risk category assigned during the same visit. Both classifications will use three ordered categories: low risk, medium risk, and high risk. Agreement will be summarized using weighted kappa and the proportion of exact matches. Weighted kappa ranges from -1 to 1, where 1 indicates perfect agreement, 0 indicates agreement equivalent to chance, and values below 0 indicate less agreement than expected by chance.

  Same visit (baseline)

• Overall Diagnostic Accuracy of Self-Assessment Tool for Periodontal Risk Classification

  Overall diagnostic accuracy of the questionnaire-derived periodontal risk classification compared with the clinical reference-standard periodontal risk classification. Accuracy will be calculated as the proportion of correctly classified participants among all participants. The value ranges from 0 to 1, where higher values indicate better classification performance.

  Same visit (baseline)

• Sensitivity and Specificity for High-Risk Periodontal Disease Detection

  Sensitivity and specificity of the self-assessment questionnaire for identifying high-risk periodontal status compared with the clinical reference-standard classification. High-risk periodontal status will be compared against non-high-risk status, which includes low-risk and medium-risk categories. Sensitivity and specificity each range from 0 to 1, where higher values indicate better diagnostic performance

  Same visit (baseline)

• Macro-Averaged F1-Score for Periodontal Risk Classification

  Macro-averaged F1-score across the three periodontal risk categories: low risk, medium risk, and high risk. The F1-score is the harmonic mean of precision and recall, calculated separately for each risk category and then averaged equally across categories. The macro-averaged F1-score ranges from 0 to 1, where higher values indicate better classification performance.

  Same visit (baseline)

Interventions

Online periodontal self-assessment questionnaire and clinical periodontal examination (reference standard) OTHER

Participants complete an online self-assessment questionnaire and undergo a same-visit clinical periodontal examination to assign a reference-standard periodontal risk category (low/medium/high). No therapeutic intervention is assigned as part of this observational study.

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 members of the general public who are scheduled for dental screening appointments at Asir Specialized Dental Center, Abha, Saudi Arabia. Recruitment and study procedures will take place at the center during the scheduled screening visit.

You may qualify if:

• Adult aged 18 years or older
• Able to read and understand the study information and provide informed consent
• Able to complete the online questionnaire independently (on a smartphone/tablet/computer)
• Willing to undergo a same-visit clinical periodontal examination
• Has natural teeth present (dentate)

You may not qualify if:

• Completely edentulous (no natural teeth)
• Currently undergoing active periodontal treatment (e.g., scaling and root planing) or received periodontal therapy within the past \[6 months\]
• Took systemic antibiotics within the past \[3 months\]
• Unable to complete the questionnaire or examination due to cognitive impairment, severe illness, or communication barriers that prevent informed consent
• Refuses or is unable to tolerate the periodontal clinical examination

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Abha Specialized Dental Center

Abhā, 'Asir Region, Saudi Arabia

RECRUITING

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

Study Officials

• Abdulrahman Ahmed Alshehri, MS

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdulrahman Ahmed Alshehri, MS

CONTACT

00966507090251; alshehriabdulrahman3@student.usm.my

Study Design

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

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 13, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

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, clinical periodontal risk label \[low/medium/high\], and derived variables) plus selected supporting documents (protocol, SAP, blank ICF, and analytic code) under a data use agreement. Requests will be reviewed by the study team, and data will be shared via a secure transfer method. No direct identifiers will be shared.

Locations

SA (1)