Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-25 @ 2:36 PM
Study NCT ID:
NCT06128850
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2023-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peri-implant Conditions Mimic Periodontal Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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': '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.'}], 'secondaryOutcomes': [{'measure': 'Periodontal pocket depth', 'timeFrame': 'Baseline', 'description': 'a pathologically deepened gingival sulcus around a tooth at the gingival margin.'}, {'measure': 'Clinical attachment level', 'timeFrame': 'Baseline', 'description': 'CAL is calculated by subtracting the gingival margin level from the probing depth.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peri-Implantitis', 'Peri-implant Mucositis', 'Peri-implant Health', 'Periodontitis', 'Gingivitis']}, 'descriptionModule': {'briefSummary': "Except for patients with referred clinical bruxism and uncontrolled medical conditions, the study included 123 implants with implanted fixed prostheses that had lasted at least six months after functional prosthetic loading. In all implant patients, the health scale ranged from implants and natural teeth to plaque, gingival index, bleeding in the probe, mouth depth, loss of clinical attachment, and dental implants. The health and illness of the implants have been determined. Patients were divided into three groups: peri-implantitis, peri-implant mucositis, and peri-implant health.\n\nInclusion Criteria:\n\n* Patients between the ages of 18- 70\n* Drugs that have a systemically healthy and controlled treatment situation\n* Drivers who have implant-supported fixed prostheses that have been at least six months after functional prosthetic loading Among these groups, it was checked whether periodontitis was seen in patients with peri-implantitis, gingivitis in patients with peri-implant mucositis, and whether healthy gums were seen in individuals with peri-implant health.\n\nTo determine the health and disease status of individuals' implants, plaque index (Silness Loe 1964), gingival index (Loe Silness 1963), bleeding on probing (Ainoma Bay 1975), pocket depth measurements, and clinical attachment level were collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The health and illness of the implants have been determined. Patients were divided into three groups: peri-implantitis, peri-implant mucositis, and peri-implant health.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 18- 70\n* Drugs that have a systemically healthy and controlled treatment situation\n* Drivers who have implant-supported fixed prostheses that have been at least six months after functional prosthetic loading\n\nExclusion Criteria:\n\n* Bruxism\n* Uncontrolled medical conditions'}, 'identificationModule': {'nctId': 'NCT06128850', 'briefTitle': 'Peri-implant Conditions Mimic Periodontal Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'Examining Peri-İmplant and Periodontal Conditions Co-occur: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': '2022/163'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peri-implantitis', 'interventionNames': ['Other: disease']}, {'label': 'Peri-implant mucositis', 'interventionNames': ['Other: disease']}, {'label': 'Peri-implant health', 'interventionNames': ['Other: disease']}], 'interventions': [{'name': 'disease', 'type': 'OTHER', 'description': 'compare to diseases', 'armGroupLabels': ['Peri-implant health', 'Peri-implant mucositis', 'Peri-implantitis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bolu', 'country': 'Turkey (Türkiye)', 'facility': 'Bolu Abant İzzet Baysal University', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Tuğba ŞAHİN', 'investigatorAffiliation': 'Abant Izzet Baysal University'}}}}