Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-26 @ 9:13 AM
Study NCT ID:
NCT04846166
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2021-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
I-Smads in Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-15', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TGF-β, Smad6, and Smad7 levels', 'timeFrame': 'baseline', 'description': 'the levels of TGF-β, Smad6, and Smad7 in gingival crevicular fluid (GCF) and saliva'}], 'secondaryOutcomes': [{'measure': 'TGF-β, Smad6, and Smad7 levels', 'timeFrame': 'baseline and 1st month after treatment', 'description': 'the levels of TGF-β, Smad6, and Smad7 in gingival crevicular fluid (GCF) and saliva before and after non-surgical periodontal treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smad', 'Periodontitis', 'Gingival crevicular fluid', 'Saliva'], 'conditions': ['Periodontitis', 'Treatment Adherence']}, 'descriptionModule': {'briefSummary': 'Recently, it has been stated that Smads play an active role in all conditions where transforming growth factor-beta (TGF-β) is involved, including periodontal inflammation. This study aimed to examine the levels of TGF-β and inhibitor Smads in saliva and gingival crevicular fluid (GCF) in patients with Stage 3 Grade B periodontitis before and after non-surgical periodontal treatment. Twenty (20) stage 3 grade B periodontitis and 20 periodontally healthy individuals were included in the study. Clinical periodontal measurements were recorded; periodontitis patients received non-surgical periodontal treatment, and GCF and saliva samples were obtained at baseline and one month after treatment. TGF-β, Smad6, and Smad7 were determined by ELISA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. group (Control): Periodontally and systemically healthy\n2. group: Systemically healthy and periodontitis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have at least 20 natural teeth, excluding third molars.\n* Periodontitis patients had at least two non-adjacent sites per quadrant with probing depth (PD) ≥ 5 mm and clinical attachment level (CAL) ≥ 5 mm with gingival inflammation, and alveolar bone loss affecting \\>30% of the teeth, as detected on clinical and radiographical examinations.\n* Periodontally healthy control group had no sign of gingival inflammation, no PD \\> 3mm and no evidence of attachment or bone loss\n\nExclusion Criteria:\n\n* History of systemic disease.\n* Regular use of any drugs which can effect the immune system or inflammatory response in the 6 months preceding the start of the study.\n* Periodontal treatment during last 6 months that could affect periodontal status.\n* Smoking.\n* History of radiotherapy or chemotherapy.\n* Current pregnancy, lactation or menopause.'}, 'identificationModule': {'nctId': 'NCT04846166', 'briefTitle': 'I-Smads in Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Bulent Ecevit University'}, 'officialTitle': 'Role of Inhibitor SMADs in Stage 3 Grade B Periodontitis Before and After Periodontal Treatment', 'orgStudyIdInfo': {'id': 'B-1921'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'interventionNames': ['Diagnostic Test: Periodontally healthy group']}, {'label': 'Periodontitis', 'interventionNames': ['Diagnostic Test: Periodontitis']}], 'interventions': [{'name': 'Periodontally healthy group', 'type': 'DIAGNOSTIC_TEST', 'description': 'probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) \\< 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium', 'armGroupLabels': ['Control']}, {'name': 'Periodontitis', 'type': 'DIAGNOSTIC_TEST', 'description': ': interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth', 'armGroupLabels': ['Periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52100', 'city': 'Ordu', 'country': 'Turkey (Türkiye)', 'facility': 'Figen Öngöz Dede', 'geoPoint': {'lat': 40.97782, 'lon': 37.89047}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'T.C. ORDU ÜNİVERSİTESİ', 'investigatorFullName': 'Figen Öngöz Dede', 'investigatorAffiliation': 'Bulent Ecevit University'}}}}