Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:05 AM
Study NCT ID:
NCT07457892
Status:
COMPLETED
Last Update Posted:
2026-03-09
First Post:
2026-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nicotine Dependence, Periodontal Awareness, and Clinical Periodontal Parameters in Smokers With Gingivitis and Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D005891', 'term': 'Gingivitis'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-03-03', 'studyFirstSubmitQcDate': '2026-03-03', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periodontal Disease Awareness', 'timeFrame': 'Baseline', 'description': 'Self-reported awareness of having periodontal disease among individuals diagnosed with gingivitis or periodontitis, determined through participant responses during clinical examination.'}], 'secondaryOutcomes': [{'measure': 'Maximum Probing Depth (PDmax)', 'timeFrame': 'Baseline', 'description': 'Maximum periodontal probing depth recorded during full-mouth periodontal examination using a standardized periodontal probe.'}, {'measure': 'Maximum Clinical Attachment Loss (CALmax)', 'timeFrame': 'Baseline', 'description': 'Maximum clinical attachment loss measured at any tooth site during periodontal examination.'}, {'measure': 'Bleeding on Probing (BOP)', 'timeFrame': 'Baseline', 'description': 'Percentage of bleeding sites recorded during periodontal probing.'}, {'measure': 'Fagerström Test for Nicotine Dependence Score (FTND)', 'timeFrame': 'Baseline', 'description': 'Nicotine dependence level measured using the Fagerström Test for Nicotine Dependence questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nicotine Dependence', 'Fagerström Test for Nicotine Dependence', 'Periodontal Disease Awareness', 'Smoking', 'Periodontal Parameters', 'Cross-Sectional Study'], 'conditions': ['Periodontal Disease', 'Gingivitis and Periodontal Diseases', 'Periodontitis']}, 'descriptionModule': {'briefSummary': 'This cross-sectional observational study aims to evaluate the association between nicotine dependence and periodontal disease awareness in individuals diagnosed with gingivitis or periodontitis. While the relationship between cigarette smoking and periodontal disease has been extensively investigated, most previous studies have focused primarily on quantitative smoking exposure measures such as the number of cigarettes smoked per day or smoking duration. In contrast, nicotine dependence represents a behavioral dimension of smoking that may influence how individuals perceive and interpret health-related symptoms.\n\nNicotine dependence will be assessed using the Fagerström Test for Nicotine Dependence (FTND). Periodontal disease awareness will be determined through patient-reported responses regarding their perception of periodontal health. In addition, clinical periodontal parameters including plaque index, bleeding on probing (BOP), probing depth (PD), and clinical attachment loss (CAL) will be recorded during routine periodontal examination.\n\nThe primary objective of this study is to investigate whether nicotine dependence level is associated with periodontal disease awareness. Secondary analyses will explore the relationships between nicotine dependence and clinical periodontal parameters to better understand potential mechanisms that may influence awareness patterns in smokers.', 'detailedDescription': 'Cigarette smoking is a well-established risk factor for periodontal disease and has been associated with increased periodontal destruction and impaired healing responses. However, smoking may also influence the perception and recognition of periodontal disease symptoms. Previous periodontal research has primarily evaluated smoking exposure using quantitative measures such as daily cigarette consumption and duration of smoking. These measures may not fully capture the behavioral and psychological aspects of nicotine addiction.\n\nNicotine dependence represents a behavioral component of smoking behavior that may affect how individuals perceive symptoms and respond to disease-related changes in their oral health. The Fagerström Test for Nicotine Dependence (FTND) is a validated instrument widely used to quantify nicotine addiction levels. Despite its extensive use in smoking research, the relationship between nicotine dependence and periodontal disease awareness has received limited attention in periodontal literature.\n\nThe present study is designed as a cross-sectional observational investigation conducted among individuals diagnosed with gingivitis or periodontitis. Participants will be recruited from patients attending a periodontal clinic. After obtaining informed consent, participants will complete the FTND questionnaire and a brief questionnaire assessing periodontal disease awareness.\n\nA comprehensive periodontal examination will be performed by an experienced periodontist. Clinical parameters including plaque index, bleeding on probing (BOP), maximum probing depth (PD), and maximum clinical attachment loss (CAL) will be recorded using standardized periodontal probes.\n\nThe primary aim of the study is to evaluate whether nicotine dependence level is associated with periodontal disease awareness. Secondary analyses will examine associations between nicotine dependence and clinical periodontal parameters, including PD, CAL, and BOP, in order to explore potential pathways linking nicotine dependence with periodontal disease perception.\n\nBy introducing nicotine dependence as a behavioral measure of smoking exposure, this study aims to provide a new perspective on the relationship between smoking and periodontal disease awareness. The findings may contribute to improved periodontal screening strategies and patient education approaches for individuals with higher nicotine dependence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants were adult smokers diagnosed with gingivitis or periodontitis who attended or were referred to the Department of Periodontology at Erzincan Binali Yıldırım University Faculty of Dentistry. Some individuals presented directly for periodontal complaints, while others were referred from other dental departments during routine dental care. Participants were consecutively recruited and evaluated for periodontal disease awareness and nicotine dependence.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 18 years or older\n* Current smokers\n* Diagnosis of gingivitis or periodontitis according to periodontal clinical examination\n* Ability to complete the Fagerström Test for Nicotine Dependence questionnaire\n* Provided informed consent to participate in the study\n\nExclusion Criteria:\n\n* Individuals with systemic diseases known to affect periodontal tissues\n* History of periodontal treatment within the previous 6 months\n* Use of medications that may influence periodontal status\n* Pregnancy or lactation\n* Inability to complete the study questionnaire'}, 'identificationModule': {'nctId': 'NCT07457892', 'briefTitle': 'Nicotine Dependence, Periodontal Awareness, and Clinical Periodontal Parameters in Smokers With Gingivitis and Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Erzincan University'}, 'officialTitle': 'Association Between Fagerström Nicotine Dependence Score, Periodontal Disease Awareness, and Clinical Periodontal Parameters in Individuals With Gingivitis or Periodontitis: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'EBYU-Awareness-2026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Periodontal Disease Aware', 'description': 'Participants diagnosed with gingivitis or periodontitis who reported being aware of having periodontal disease.'}, {'label': 'Periodontal Disease Unaware', 'description': 'Participants diagnosed with gingivitis or periodontitis who reported not being aware of having periodontal disease.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '24100', 'city': 'Erzincan', 'state': 'Province', 'country': 'Turkey (Türkiye)', 'facility': 'Erzincan Binali Yıldırım University Faculty of Dentistry', 'geoPoint': {'lat': 39.73919, 'lon': 39.49015}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzincan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Erzincan Binali Yıldırım University Faculty of Dentistry', 'investigatorFullName': 'Ömer Faruk Okumuş', 'investigatorAffiliation': 'Erzincan University'}}}}