Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 2:06 PM
Study NCT ID:
NCT05706493
Status:
COMPLETED
Last Update Posted:
2025-02-11
First Post:
2023-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Periodontitis and the Level of Anti-citrullinated Protein Antibodies in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'there will be two outcome assessor one before the non surgical periodontal treatment and the other one will be after non surgical periodontal treatment with 3 months'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "According to the periodontal parameters measured the cases will be categorized according to the latest classification of the 2017 World Workshop of classification of periodontal diseases and conditions as follows: staging of periodontitis is mainly based on the interdental CAL at the site of greatest loss and on radiographic bone loss and on tooth loss, over 4 stages-stage I, initial; stage II, moderate; stage III, severe; and stage IV, advanced periodontitis, Patient periodontal status will be assessed using William's graduated periodontal probe.Non-surgical periodontal treatment will be performed using ultrasonic scaler and subgingival curettes"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-08', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the level of anti-citrullinated protein antibodies (ACPAs)', 'timeFrame': 'at baseline and 3 months', 'description': 'assessment of the level of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid'}], 'secondaryOutcomes': [{'measure': 'Change in Clinical attachment Loss', 'timeFrame': 'at baseline and 3 months', 'description': 'measuring the distance from the cemento enamel junction to the base of the pocket in mm'}, {'measure': 'Change in Probing depth', 'timeFrame': 'at baseline and 3 months', 'description': 'measuring the distance from the gingival margin to the base of the pocket in mm'}, {'measure': 'Change in Plaque index (PI)', 'timeFrame': 'at baseline and 3 months', 'description': 'it is a score (0,1,2 and 3) where: 0 = No plaque in the gingival area. 1 = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface. 2 = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye. 3 = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontitis', 'rheumatoid arthritis', 'anti citrullinated protein antibodies', 'peptidyl arginine deminase enzyme', 'gingival crevicular fluid (GCF)'], 'conditions': ['Periodontal Diseases', 'Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'the relationship between rheumatoid arthritis and periodontal disease is crucial and has been explained via a complex interplay of genetic, environmental, and hormonal factors that influence the host immune tolerance leading to both disease characteristics. The aim of this study is to clinically investigate the correlation between the levels of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid before and after non-surgical periodontal treatment and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients', 'detailedDescription': "the relationship between rheumatoid arthritis and periodontal disease is crucial and has been explained via a complex interplay of genetic, environmental, and hormonal factors that influence the host immune tolerance leading to both disease characteristics.\n\nThe aim of this study is to clinically investigate the correlation between the levels of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid before and after non-surgical periodontal treatment and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients Materials and Methods: a total of 40 participants suffering from periodontitis and rheumatoid arthritis will be referred from the Badr Hospital (Faculty of Medicine, Helwan University) to Misr international university's dental clinic complex. Gingival crevicular fluid (GCF) samples will be collected from the patients before performing periodontal therapy (baseline). Assessment of ACPAs will be quantified using enzyme-linked immunoassay (ELISA) as the primary outcome at baseline and after 3 months. Assessment of 2ry outcomes includes clinical periodontal and RA parameters at baseline and after 3 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rheumatoid patients fulfilling the ACR criteria for the classification of RA\n\n * 18 years\n* Both genders\n* Presence of at least 8 teeth\n\nExclusion Criteria:\n\n* Smoking\n* Diabetes Mellitus\n* Pregnant females\n* Patients who had undergone periodontal treatment within last 3 months\n* Antibiotic therapy during last 3 months\n* Other autoimmune diseases'}, 'identificationModule': {'nctId': 'NCT05706493', 'briefTitle': 'Association Between Periodontitis and the Level of Anti-citrullinated Protein Antibodies in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Misr International University'}, 'officialTitle': 'Association Between Severity of Periodontitis and the Level of Anti-citrullinated Protein Antibodies (ACPAs) in Rheumatoid Arthritis Patients Before and After Non-surgical Periodontal Treatment (Pre and Post Study)', 'orgStudyIdInfo': {'id': 'PER 3312007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Non-surgical periodontal treatment', 'description': 'assessment of different periodontal parameters and gingival crevicular fluid sampling will be done then non surgical periodontal treatment will be performed then after 3 months re assessment of the periodontal parameters and gingival crevicular fluid sampling will be done', 'interventionNames': ['Other: Non surgical periodontal treatment']}], 'interventions': [{'name': 'Non surgical periodontal treatment', 'type': 'OTHER', 'description': 'Non-surgical periodontal treatment will be performed using ultrasonic scaler and subgingival curettes', 'armGroupLabels': ['Non-surgical periodontal treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of oral and dental medicine, Misr international university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Zainab Hafez, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer, faculty of oral and dental medicine misr international university'}, {'name': 'Yahia Hassan, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer, faculty of oral and dental medicine misr international university'}, {'name': 'Shahinaz Al ashiry, asso.Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate Professor, faculty of oral and dental medicine misr international universit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Misr International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}