Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-02 @ 4:49 PM
Study NCT ID:
NCT03128502
Status:
COMPLETED
Last Update Posted:
2017-06-15
First Post:
2017-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Pentrexin-3 Levels in GCF and Saliva of Patients With Periodontal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D010520', 'term': 'Aggressive Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'salivary and GCF samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-14', 'studyFirstSubmitDate': '2017-04-21', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GCF and salivary pentraxin-3 levels', 'timeFrame': 'baseline', 'description': 'levels of pentraxin-3 in GCF and saliva'}], 'secondaryOutcomes': [{'measure': 'plaque index', 'timeFrame': 'baseline', 'description': 'Oral hygiene status of the patients were recorded using the plaque index of Silness \\& Lӧe (1964)'}, {'measure': 'gingival index', 'timeFrame': 'baseline', 'description': 'Performed using the gingival index of Lӧe (1967)'}, {'measure': 'probing pocket depth', 'timeFrame': 'baseline', 'description': "The depths of the periodontal pockets were measured as the distance from the gingival margin to the base of the pocket using periodontal probe with William's graduation."}, {'measure': 'clinical attachment level', 'timeFrame': 'baseline', 'description': "Clinical attachment levels were measured as the distance from the CEJ to the base of the pocket using William's graduated periodontal probe."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['saliva', 'GCF', 'pentraxin-3'], 'conditions': ['Chronic Periodontitis', 'Aggressive Periodontitis']}, 'referencesModule': {'references': [{'pmid': '21932007', 'type': 'RESULT', 'citation': 'Fujita Y, Ito H, Sekino S, Numabe Y. Correlations between pentraxin 3 or cytokine levels in gingival crevicular fluid and clinical parameters of chronic periodontitis. Odontology. 2012 Jul;100(2):215-21. doi: 10.1007/s10266-011-0042-1. Epub 2011 Sep 20.'}, {'pmid': '23701480', 'type': 'RESULT', 'citation': 'Lakshmanan R, Jayakumar ND, Sankari M, Padmalatha O, Varghese S. Estimation of pentraxin-3 levels in the gingival tissues of chronic and aggressive periodontitis participants: an in vivo study. J Periodontol. 2014 Feb;85(2):290-7. doi: 10.1902/jop.2013.120718. Epub 2013 May 23.'}, {'pmid': '23952075', 'type': 'RESULT', 'citation': 'Gumus P, Nizam N, Nalbantsoy A, Ozcaka O, Buduneli N. Saliva and serum levels of pentraxin-3 and interleukin-1beta in generalized aggressive or chronic periodontitis. J Periodontol. 2014 Mar;85(3):e40-6. doi: 10.1902/jop.2013.130281. Epub 2013 Aug 16.'}]}, 'descriptionModule': {'briefSummary': 'Subjects were selected from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University. Ten healthy control subjects presented with clinically healthy periodontium. Ten patients who had plaque induced gingivitis. Ten patients who had generalized chronic periodontitis. Ten patients who had generalised aggressive periodontitis. Pentraxin-3 levels were evaluated in GCF and saliva of all subjects included in this study with ELISA technique.', 'detailedDescription': 'The study population consisted of 4 groups of forty patients selected as follows:\n\nGroup 1 - Healthy Controls:\n\nTen healthy control subjects presented with clinically healthy periodontium. Control subjects had to meet the following criteria for inclusion: probing depth less than 3mm, no clinical attachment loss, no bleeding on probing, with Gingival and Plaque index 0-1.\n\nGroup 2 - Plaque induced gingivitis patients:\n\nTen patients who had plaque induced gingivitis characterized by the presence of any of the following clinical signs: redness and edema of the gingival tissue, bleeding upon provocation, changes in contour and consistency, presence of calculus and/or plaque, with no clinical attachment loss nor radiographic evidence of bone loss.\n\nGroup 3 - Chronic periodontitis group:\n\nTen chronic moderate to severe periodontitis patients selected according to the criteria currently adopted by Armitage 1999. Moderate destruction is generally characterized by periodontal probing depths up to 6 mm with clinical attachment loss of up to 4 mm. Advanced destruction is generally characterized by periodontal probing depths greater than 6 mm with attachment loss greater than 4 mm. Radiographic evidence of bone loss is apparent, Increased tooth mobility may be present.\n\nGroup 4 - Aggressive periodontitis group:\n\nTen patients suffering generalized aggressive periodontitis, patients were less than 35 years of age and had generalized interproximal attachment loss affecting at least 3 permanent teeth other than the first molars and incisors with at least one site each with PD and CAL \\>5 mm, Attachment loss occurs in pronounced episodic periods of destruction, and there is familial aggregation (subjects were asked if they had at least one other member of the family presenting or with a history of periodontal diseases).\n\nGCF and saliva samples were collected for all patients. Pentraxin-3 levels were evaluated in GCF and saliva of all subjects included in this study with ELISA technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Oral and Dental Medicine, Cairo University suffering from diffrent periodontal diseases.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with plaque induced gingivitis\n* patients with chronic periodontitis\n* patients with aggressive periodontitis\n\nExclusion Criteria:\n\n* Patients with any systemic disease according to Cornell medical index (1968).\n* Patients taking any medications or antibiotics in the last 3 months.\n* Current or former smoker patients.\n* Pregnant females.'}, 'identificationModule': {'nctId': 'NCT03128502', 'briefTitle': 'Estimation of Pentrexin-3 Levels in GCF and Saliva of Patients With Periodontal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessment of Pentraxin-3 Levels in Gingival Crevicular Fluid and Saliva in Periodontal Health and Disease', 'orgStudyIdInfo': {'id': 'PTX-3_AgP_CP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'healthy control', 'description': 'Ten healthy control subjects presented with clinically healthy periodontium. Control subjects had to meet the following criteria for inclusion: probing depth less than 3mm, no clinical attachment loss, no bleeding on probing, with Gingival and Plaque index 0-1.'}, {'label': 'plaque induced gingivitis', 'description': 'Ten patients who had plaque induced gingivitis characterized by the presence of any of the following clinical signs: redness and edema of the gingival tissue, bleeding upon provocation, changes in contour and consistency, presence of calculus and/or plaque, with no clinical attachment loss nor radiographic evidence of bone loss.'}, {'label': 'chronic periodontitis', 'description': 'Ten chronic moderate to severe periodontitis patients selected according to the criteria currently adopted by Armitage 1999. Moderate destruction is generally characterized by periodontal probing depths up to 6 mm with clinical attachment loss of up to 4 mm. Advanced destruction is generally characterized by periodontal probing depths greater than 6 mm with attachment loss greater than 4 mm. Radiographic evidence of bone loss is apparent, Increased tooth mobility may be present.'}, {'label': 'aggressive periodontitis', 'description': 'Ten patients suffering generalized aggressive periodontitis, patients were less than 35 years of age and had generalized interproximal attachment loss affecting at least 3 permanent teeth other than the first molars and incisors with at least one site each with PD and CAL \\>5 mm, Attachment loss occurs in pronounced episodic periods of destruction, and there is familial aggregation (subjects were asked if they had at least one other member of the family presenting or with a history of periodontal diseases).'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Engy Ahmed, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate Professor of Oral Medicine & Periodontology, faculty of Oral and Dental Medicine, Cairo University'}, {'name': 'Yasmine Mansour, B.D.Sc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'master candidate at faculty of dentistry cairo university'}, {'name': 'Olfat Shaker', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Medical Biochemistry, Faculty of Medicine, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University.', 'investigatorFullName': 'Noha Ayman Ghallab', 'investigatorAffiliation': 'Cairo University'}}}}