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临床试验/NCT07410351
NCT07410351招募中不适用

Development and Validation of a Self-assessment Tool for Periodontal Disease Risk Assess Among the Saudi Population Using Semi-supervised Learning

Universiti Sains Malaysia1 个研究点 分布在 1 个国家目标入组 393 人开始时间: 2026年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
393
试验地点
1
主要终点
Agreement between self-assessment risk category and clinical periodontal risk category

研究概览

简要总结

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.

详细描述

Periodontal disease is a common oral health problem that can progress silently and may lead to gum inflammation, tooth loss, and reduced quality of life if not detected and managed early. Many people may not recognize early signs or may delay seeking dental care until symptoms become more noticeable. An online self-assessment tool may help members of the public identify whether they are at higher risk and encourage timely evaluation and preventive care.

This observational study will collect labeled data to evaluate the accuracy of an online periodontal self-assessment tool in the general adult population. Participants will complete a structured online questionnaire that asks about oral and periodontal health symptoms, dental history, oral hygiene practices, and other health-related factors commonly linked to periodontal risk. During the same visit, each participant will undergo a standardized clinical periodontal examination conducted by a trained clinician. The clinical examination will serve as the reference standard to assign a periodontal risk label for each participant, categorized as low, medium, or high risk according to predefined criteria in the study protocol.

The primary purpose of this labeled-data phase is to compare the questionnaire-based assessment with the clinically determined risk level (low/medium/high) to determine how well the self-assessment tool identifies periodontal risk in the general public. Primary analyses will evaluate agreement and accuracy between questionnaire outputs and the clinical reference label (for example, diagnostic accuracy measures and agreement statistics).

This study does not assign any treatment or preventive intervention. Study activities include completion of an online questionnaire and a same-visit periodontal clinical examination. Risks are minimal and may include mild, temporary discomfort or minor bleeding during periodontal probing, as well as potential privacy risks related to collection of questionnaire responses and clinical findings. To protect confidentiality, participants' data will be recorded using a study identifier rather than direct personal identifiers and will be stored in secure, access-controlled systems accessible only to authorized study personnel.

The results of this study are expected to support validation and refinement of the self-assessment tool and inform future efforts to improve early identification of periodontal risk and promote preventive oral health care at the community level.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

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

时间窗: Same visit (baseline)

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.

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

时间窗: Same visit (baseline)

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.

Sensitivity and Specificity for High-Risk Periodontal Disease Detection

时间窗: Same visit (baseline)

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

Macro-Averaged F1-Score for Periodontal Risk Classification

时间窗: Same visit (baseline)

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdulrahman Ahmed M. Alshehri

Principal Investigator, Periodontist

Universiti Sains Malaysia

研究点 (1)

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