Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-22 @ 6:28 PM
Study NCT ID:
NCT03227367
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2017-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D016301', 'term': 'Alveolar Bone Loss'}, {'id': 'D001862', 'term': 'Bone Resorption'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Control group: (Healthy individuals) comprised of 25 participants with clinically healthy periodontium.\n\nTest group: (Chronic periodontitis patients) comprised of 25 participants with signs of clinical inflammation and bone loss.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-24', 'studyFirstSubmitDate': '2017-06-25', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'probing pocket depth', 'timeFrame': 'base line', 'description': 'probing pocket dept was measured using Williams periodontal probe at base line'}], 'secondaryOutcomes': [{'measure': 'Protein expression on osteoclast cells was estimated with BCP, PRF alone and BCP/PRF combination.', 'timeFrame': '24 hours from baseline', 'description': 'Protein expression on cells was analyzed using Western blot in all the groups'}, {'measure': 'The activity of caspase-3 in OCs.', 'timeFrame': '24 hours from base line', 'description': 'The activity of caspase-3 was seen in OCs in all the groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biomaterials', 'apoptosis', 'bone regeneration'], 'conditions': ['Periodontal Disease', 'Periodontal Bone Loss', 'Osteoclastic Bone Loss']}, 'referencesModule': {'references': [{'pmid': '22624763', 'type': 'RESULT', 'citation': 'Wu CL, Lee SS, Tsai CH, Lu KH, Zhao JH, Chang YC. Platelet-rich fibrin increases cell attachment, proliferation and collagen-related protein expression of human osteoblasts. Aust Dent J. 2012 Jun;57(2):207-12. doi: 10.1111/j.1834-7819.2012.01686.x.'}, {'pmid': '16848983', 'type': 'RESULT', 'citation': 'Colucci S, Mori G, Brunetti G, Coricciati M, Pignataro P, Oranger A, Cirulli N, Mastrangelo F, Grassi FR, Grano M. Interleukin-7 production by B lymphocytes affects the T cell-dependent osteoclast formation in an in vitro model derived from human periodontitis patients. Int J Immunopathol Pharmacol. 2005 Jul-Sep;18(3 Suppl):13-9.'}]}, 'descriptionModule': {'briefSummary': 'The present study is an effort to investigate the hypothesis that Platelet Rich Fibrin/Biphasic Calcium Phosphate may play a role in inhibiting osteoclasts differentiation and in bone loss.', 'detailedDescription': 'Study design\n\nFifty-five individuals from a suburban population were recruited. Out of them, 5 individuals refused to participate in the study. Finally, 50 participants were selected and divided into two groups, control group \\[Healthy individuals\\]: 25 Males/Females, aged 25 to 35 years and test group \\[Chronic periodontitis patients\\]: 25 Males/Females aged 30 to 45 years.\n\nDemographic variables and periodontal parameters were measured in both the groups.The investigators explored the effect of Platelet rich fibrin (PRF)/Biphasic calcium phosphate (BCP) on differentiation and survival of osteoclasts obtained from peripheral blood of Chronic Periodontitis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria: (Control group)\n\n* Subjects with age group between 30 to 45 years.\n* Non-smokers.\n* No previous history of periodontal treatment.\n\nInclusion Criteria: (Test group)\n\n* Subjects with age group between 30 to 45 years.\n* Presence of atleast 20 teeth\n* More than 30% of the sites with clinical attachment loss.\n* Non-smokers.\n* No previous history of periodontal treatment.\n\nExclusion Criteria: ( both the groups)\n\n* Individuals with systemic disease\n* Subjects under antibiotics or anti-inflammatory drugs within the previous 3 months.\n* Pregnant and lactating women.\n* Allergic to antibiotics.'}, 'identificationModule': {'nctId': 'NCT03227367', 'briefTitle': 'Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials.', 'organization': {'class': 'OTHER', 'fullName': 'Meenakshi Ammal Dental College and Hospital'}, 'officialTitle': 'Platelet Rich Fibrin/Biphasic Calcium Phosphate Impairs Osteoclasts Differentiation and Promotes Apoptosis by the Intrinsic Mitochondrial Pathway in Chronic Periodontitis', 'orgStudyIdInfo': {'id': 'MU-107-IEC/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group', 'description': 'Mononuclear cells isolated from the peripheral blood of 25 chronic periodontitis patients were interveened with 1ml/well preparation of Platelet rich fibrin(PRF), Biphasic calcium phosphate (BCP) and PRF and BCP combination in-vitro.', 'interventionNames': ['Other: other : PRF']}, {'type': 'OTHER', 'label': 'control group', 'description': 'Mononuclear cells isolated from the peripheral blood of healthy individuals in-vitro.', 'interventionNames': ['Other: other : PRF']}], 'interventions': [{'name': 'other : PRF', 'type': 'OTHER', 'otherNames': ['others : BCP', 'others : PRF/BCP combination'], 'description': 'mononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination', 'armGroupLabels': ['Test group', 'control group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'shila samuel, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VRR diagnostic institute chennai'}, {'name': 'jaideep mahendra, MDS,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'meenakshi ammal dental college chennai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meenakshi Ammal Dental College and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director post graduate studies', 'investigatorFullName': 'Dr.Jaideep Mahendra', 'investigatorAffiliation': 'Meenakshi Ammal Dental College and Hospital'}}}}