Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 1:37 AM
Study NCT ID:
NCT07410351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of A Self-Assessment Tool for Personalized Preventive Periodontal Care Among the Saudi Population Using Semi-Supervised Learning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012015', 'term': 'Reference Standards'}], 'ancestors': [{'id': 'D014894', 'term': 'Weights and Measures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 393}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-07', 'studyFirstSubmitDate': '2026-01-31', 'studyFirstSubmitQcDate': '2026-02-07', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement between self-assessment risk category and clinical periodontal risk category', 'timeFrame': 'Same visit (baseline)', 'description': 'Agreement between the questionnaire-derived periodontal risk category (low/medium/high) and the reference-standard clinical periodontal risk category (low/medium/high) assigned during the same visit. Agreement will be summarized using an agreement statistic (e.g., weighted kappa) and the proportion of exact matches.'}, {'measure': 'Overall Diagnostic Accuracy of Self-Assessment Tool for Periodontal Risk Classification', 'timeFrame': 'Same visit (baseline)', 'description': 'Overall accuracy of the questionnaire-derived risk classification (low/medium/high) compared with the clinical reference-standard risk label, calculated as the proportion of correctly classified participants among all participants.'}, {'measure': 'Sensitivity and Specificity for High-Risk Periodontal Disease Detection', 'timeFrame': 'Same visit (baseline)', 'description': 'Sensitivity and specificity of the self-assessment questionnaire for identifying high-risk versus non-high-risk periodontal disease status compared with clinical reference-standard classification.'}, {'measure': 'Macro-Averaged F1-Score for Periodontal Risk Classification', 'timeFrame': 'Same visit (baseline)', 'description': 'Macro-averaged F1-score across all three risk categories (low/medium/high) for the questionnaire-derived risk classification compared with clinical reference-standard risk label.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periodontal diseases', 'risk assessment', 'self-report'], 'conditions': ['Periodontal Diseases', 'Periodontitis', 'Gingivitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThis 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.\n\nThe 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).\n\nThis 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult aged 18 years or older\n* Able to read and understand the study information and provide informed consent\n* Able to complete the online questionnaire independently (on a smartphone/tablet/computer)\n* Willing to undergo a same-visit clinical periodontal examination\n* Has natural teeth present (dentate)\n\nExclusion Criteria:\n\n* Completely edentulous (no natural teeth)\n* Currently undergoing active periodontal treatment (e.g., scaling and root planing) or received periodontal therapy within the past \\[6 months\\]\n* Took systemic antibiotics within the past \\[3 months\\]\n* Unable to complete the questionnaire or examination due to cognitive impairment, severe illness, or communication barriers that prevent informed consent\n* Refuses or is unable to tolerate the periodontal clinical examination'}, 'identificationModule': {'nctId': 'NCT07410351', 'briefTitle': 'Development of A Self-Assessment Tool for Personalized Preventive Periodontal Care Among the Saudi Population Using Semi-Supervised Learning', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Malaysia'}, 'officialTitle': 'Development and Validation of a Self-assessment Tool for Periodontal Disease Risk Assess Among the Saudi Population Using Semi-supervised Learning', 'orgStudyIdInfo': {'id': 'USM/JEPeM/KK/25050469'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Online periodontal self-assessment questionnaire and clinical periodontal examination (reference standard)', 'type': 'OTHER', 'description': '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.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abdulrahman Ahmed Alshehri, MS', 'role': 'CONTACT', 'email': 'alshehriabdulrahman3@student.usm.my', 'phone': '00966507090251'}], 'overallOfficials': [{'name': 'Abdulrahman Ahmed Alshehri, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Sains Malaysia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': '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.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (questionnaire responses, clinically assigned periodontal risk category, and relevant derived variables) will be made available to qualified researchers upon reasonable request and approval by the study team and ethics requirements.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Periodontist', 'investigatorFullName': 'Abdulrahman Ahmed M. Alshehri', 'investigatorAffiliation': 'Universiti Sains Malaysia'}}}}