Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT07295756
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Smoking in Periodontal Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D000074602', 'term': 'Smoking Devices'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 484}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'periodontal pocket depth', 'timeFrame': 'Baseline', 'description': 'Periodontal pocket depth measured in millimeters using a Williams periodontal probe. The distance from the gingival margin to the bottom of the periodontal pocket was recorded at each site.'}], 'secondaryOutcomes': [{'measure': 'bleeding on probing', 'timeFrame': 'Baseline', 'description': 'Bleeding on probing assessed using a periodontal probe. After gently inserting the probe into the gingival sulcus and moving it laterally along the pocket wall, bleeding was recorded as present (+) or absent (-).pocket and gently moved laterally along the pocket wall. + is maximum and - is minimum.'}, {'measure': 'plaque index', 'timeFrame': 'Baseline', 'description': 'Oral hygiene status assessed using the Plaque Index, which measures dental plaque accumulation adjacent to the gingival margin. Scores range from 0 (no plaque) to 3 (abundant plaque), with higher scores indicating poorer oral hygiene.'}, {'measure': 'gingival index', 'timeFrame': 'Baseline', 'description': 'Gingival inflammation assessed using the Löe and Silness Gingival Index. Each site was scored on a 0-3 scale, where 0 = normal gingiva and 3 = severe inflammation with edema, redness, and spontaneous bleeding. Higher scores indicate worsening gingival inflammation.'}, {'measure': 'clinical attachment level', 'timeFrame': 'Baseline', 'description': 'Clinical attachment level measured in millimeters using a periodontal probe. CAL was calculated as the distance from the cementoenamel junction to the bottom of the periodontal pocket and used to assess periodontal tissue support loss.'}, {'measure': 'Daily cigarette', 'timeFrame': 'Baseline', 'description': 'It includes the number of cigarettes smoked per day. Self-reported number of cigarettes smoked per day.'}, {'measure': 'Smoking Duration', 'timeFrame': 'Baseline', 'description': 'Self-reported duration of smoking, recorded as the number of years the participant has smoked.'}, {'measure': 'Pack-years', 'timeFrame': 'Baseline', 'description': 'Smoking exposure calculated as pack-years, defined as the number of cigarettes smoked per day divided by 20 and multiplied by the number of years of smoking.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontal diseases', 'periodontitis', 'smoking', 'gingivitis', 'tabocco products'], 'conditions': ['Periodontal Diseases']}, 'descriptionModule': {'briefSummary': "484 patients were asked whether they currently smoked and whether they had smoked 100 or more cigarettes during their lifetime. Based on this information, they were divided into two groups: current smokers (test group, n=242) and non-smokers (control group, n=242). Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking. In contrast, non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking. Participants were also asked about the number of cigarettes smoked per day and the duration of smoking in years, and pack-years were calculated accordingly. Plaque index, gingival index, probing depth, bleeding on probing, gingival recession, and attachment loss were evaluated for both groups. Periodontal health status (Periodontal health, gingivitis, and periodontitis) was assessed by one clinician applying the 2017 World Workshop on Classifying Periodontal and Peri-Implant Diseases and Conditions and the 2023 European Federation of Periodontology's Guidelines. Patients with periodontitis were classified according to stage and grade. This measurement was obtained via a calibrated UNC-15 periodontal probe at each tooth.", 'detailedDescription': "484 patients were asked whether they currently smoked and had smoked 100 or more cigarettes during their lifetime. Based on this information, they were divided into two groups: current smokers (test group, n=242) and non-smokers (control group, n=242). Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking. In contrast, non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking. Participants were also asked about the number of cigarettes smoked per day and the duration of smoking in years, and pack-years were calculated accordingly. Plaque index, gingival index, probing depth, bleeding on probing, gingival recession, and attachment loss were evaluated for both groups. Periodontal health status (Periodontal health, gingivitis, and periodontitis) was assessed by one clinician applying the 2017 World Workshop on Classifying Periodontal and Peri-Implant Diseases and Conditions and the 2023 European Federation of Periodontology's Guidelines. Patients with periodontitis were classified according to stage and grade. This measurement was obtained via a calibrated UNC-15 periodontal probe at each tooth."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study includes patients who are smokers and those who are non-smokers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* No systemic diseases that could affect periodontal or general health\n* No history of periodontal treatment within the past six months\n* For the non-smoker group: abstinence from smoking for at least five years\n\nExclusion Criteria:\n\n* Use of antibiotics or anti-inflammatory drugs\n* Pregnant or lactating women\n* Diabetes mellitus\n* Use of waterpipe or chewing tobacco (for the smoker group)\n* Individuals undergoing chemotherapy or radiotherapy'}, 'identificationModule': {'nctId': 'NCT07295756', 'acronym': 'TRSPS', 'briefTitle': 'The Role of Smoking in Periodontal Status', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'The Role of Smoking Habits in Periodontal Health and Disease: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'BAIBU-DH-TS-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smoker', 'description': 'Current smokers were defined as individuals who had smoked ≥100 cigarettes in their lifetime and continued smoking.', 'interventionNames': ['Other: Intervention']}, {'label': 'Non-smoker', 'description': 'Non-smokers included individuals who had smoked fewer than 100 cigarettes in their lifetime and were not currently smoking.', 'interventionNames': ['Other: Intervention']}], 'interventions': [{'name': 'Intervention', 'type': 'OTHER', 'otherNames': ['Smoking'], 'description': "The patient's daily cigarette consumption, duration of smoking, and pack-years were evaluated.", 'armGroupLabels': ['Non-smoker', 'Smoker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14030', 'city': 'Bolu', 'country': 'Turkey (Türkiye)', 'facility': 'Bolu Abant Izzet Baysal University, Dentistry Faculty', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}], 'overallOfficials': [{'name': 'TUGBA SAHIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abant Izzet Baysal University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tuğba ŞAHİN', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Tuğba ŞAHİN', 'investigatorAffiliation': 'Abant Izzet Baysal University'}}}}