Development of A Self-Assessment Tool for Personalized Preventive Periodontal Care Among the Saudi Population Using Semi-Supervised Learning
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Online periodontal self-assessment questionnaire and clinical periodontal examination (reference standard).
- Кому может быть актуально
- Состояния в реестре: Periodontal Diseases, Periodontitis, Gingivitis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Саудовская Аравия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Development and Validation of a Self-assessment Tool for Periodontal Disease Risk Assess Among the Saudi Population Using Semi-supervised Learning
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Online periodontal self-assessment questionnaire and clinical periodontal examination (reference standard)
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.
Первичные конечные точки
- Agreement between self-assessment risk category and clinical periodontal risk category [Срок оценки: Same visit (baseline)]
- Overall Diagnostic Accuracy of Self-Assessment Tool for Periodontal Risk Classification [Срок оценки: Same visit (baseline)]
- Sensitivity and Specificity for High-Risk Periodontal Disease Detection [Срок оценки: Same visit (baseline)]
- Macro-Averaged F1-Score for Periodontal Risk Classification [Срок оценки: Same visit (baseline)]
Критерии участия
Критерии включения
- 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)
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Саудовская Аравия · 1 центр
- Abha Specialized Dental Center — Abhā
Идентификаторы
NCT: NCT07410351 · USM/JEPeM/KK/25050469