Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-20 @ 6:04 PM
Study NCT ID:
NCT05921357
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2023-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Fermented Products and Probiotics on the Condition of the Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-02', 'studyFirstSubmitDate': '2023-06-18', 'studyFirstSubmitQcDate': '2023-06-18', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consumption frequency', 'timeFrame': 'Baseline', 'description': 'the number of times a product is consumed in a given time period.'}, {'measure': 'Consumption amount', 'timeFrame': 'Baseline', 'description': 'The average quantity of an item consumed or expended during a given time interval, expressed in quantities by the most appropriate unit of measurement per applicable stated basis.'}, {'measure': 'Daily intake', 'timeFrame': 'Baseline', 'description': 'The amount of a substance that people can consume on a daily basis'}, {'measure': 'Bleeding on probing', 'timeFrame': 'Baseline', 'description': 'Bleeding, leading sign of inflammation inside the connective tissue, is a critical factor for pocket depth measurements, and with other variable factors prevents making reproducible measurements.'}, {'measure': 'Periodontal pocket depth', 'timeFrame': 'Baseline', 'description': 'a pathologically deepened gingival sulcus around a tooth at the gingival margin.'}], 'secondaryOutcomes': [{'measure': 'Plaque index', 'timeFrame': 'Baseline', 'description': 'The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth'}, {'measure': 'Gingival index', 'timeFrame': 'Baseline', 'description': 'This measurement is based on the presence or absence of bleeding on gentle probing.'}, {'measure': 'Clinical attachment level', 'timeFrame': 'Baseline', 'description': 'CAL is calculated by subtracting the gingival margin level from the probing depth.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fermented foods', 'probiotics', 'peri-implant health', 'peri-implant mucositis', 'peri-implantitis'], 'conditions': ['Implant']}, 'descriptionModule': {'briefSummary': "126 individuals with peri-implant disease and health, aged between 18-70 years, who applied to Bolu University Faculty of Dentistry Periodontology Clinic, participated in the study.The inclusion criteria for patient participation in the study were: age of patients between 18 and 70 years; the presence of at least 20 natural teeth in the oral cavity; systemic health. Peri-implant status was determined by the clinician (T.Ş.) by evaluating dental implants' plaque, gingival index, bleeding on probing, pocket depth measurements, and clinical attachment level. In addition, them systemic illness, pregnancy, breastfeeding status, medication, antibiotic use, and whether they smoked were questioned. Systemically unhealthy patients who did not use antibiotics within a month, were breastfeeding or pregnant, had uncontrolled diabetes, rheumatic fever, a history of lung and kidney disorders, and used drugs that could affect periodontal tissues were not included in the study. After examination, the patients were divided into three groups according to their disease: Peri-implantitis (42 patients), peri-implantitis (42 patients), and peri-implant health (42 patients). Demographic characteristics (age, weight, gender, height, education, and employment status) of the participants were collected with a questionnaire. With this survey, fermented foods and probiotic products such as bacon, soy sauce, pickles, sourdough bread, whole grain, rye, wholemeal bread, ayran, kefir, turnip, vinegar (homemade), pomegranate syrup (homemade), probiotic beverage, the frequency and amount of consumption of cheese, dark chocolate, tablets, capsules, chassis, butter and other (Kimchi, sauerkrauth, miso soup, fermented herring, kombucha, etc.) were determined. It was requested to determine the relationship between the health and disease of the implant and the frequency of consumption of fermented and probiotic products and foods in individuals with implants."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Bolu Abant İzzet Baysal University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy individuals\n* Individuals between the ages of 18-70\n\nExclusion Criteria:\n\n* No use of antibiotics within one month\n* Breastfeeding or being pregnant\n* Uncontrolled diabetes, rheumatic fever, history of lung and kidney disorders, and drug use that will affect periodontal tissues'}, 'identificationModule': {'nctId': 'NCT05921357', 'acronym': 'EFFPCFPDH', 'briefTitle': 'Effect of Fermented Products and Probiotics on the Condition of the Implant', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'Evaluation of Fermented Foods and Probiotic Consumption Frequency in Peri-implant Disease and Health', 'orgStudyIdInfo': {'id': '2022/196'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peri-implantitis', 'description': 'Implants with a pocket depth of more than 5 mm and bleeding on probing', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Peri-implant mucositis', 'description': 'Implants with no bone loss but bleeding on probing', 'interventionNames': ['Other: Questionnaire']}, {'label': 'Peri-implant health', 'description': 'Implants with no bone loss but no bleeding on probing', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Questionnaire and examine', 'armGroupLabels': ['Peri-implant health', 'Peri-implant mucositis', 'Peri-implantitis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bolu', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'facility': 'Bolu Abant İzzet Baysal University', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}]}, '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'}}}}