Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-26 @ 4:51 PM
Study NCT ID:
NCT03522532
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2018-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "According to Black's Classification Criteria, patients were classified into four groups (K2 - K5). The number of patients within those groups were as follows: K2 (n=58), K3 (n=10), K4 (n=6) and K5 (n=14).\n\nSix different DMs were used in this study. The type of DM to be used for each patient was determined in relation to the dental lesion degree. DM placement was performed in one session and only one type was used per patient. Accordingly, 6 groups (arms) of dental patients (Amg, ZnPhC, ZnPoC, GIC, TEC and BF) were formed.\n\nParameters of OS (MDA, GSH and tSOD) were measured in the GCF of the patients both before (day 0) and after treatment (on the 7th and 30th day)."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2018-04-17', 'studyFirstSubmitQcDate': '2018-04-30', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in tSOD activity in dental patients GCF after the applied treatments', 'timeFrame': '0th, 7th and 30th days.', 'description': 'Activity of tSOD was measured before (0 day) and twice after the applied treatments (7th and 30th days). GCF was taken via the intracervical absorption technique. Control GCF (from mirror-positioned health teeth) was taken once before the treatment.'}], 'primaryOutcomes': [{'measure': 'Changes in the levels of MDA in dental patients GCF after the applied treatments', 'timeFrame': '0th, 7th and 30th days.', 'description': 'The concentration of MDA in GCF was measured before (0 day) and twice after the applied treatments (7th and 30th days). GCF was taken via the intracervical absorption technique. Control GCF (from mirror-positioned health teeth) was taken once before the treatment.'}], 'secondaryOutcomes': [{'measure': 'Changes in the levels of GSH in dental patients GCF after the applied treatments', 'timeFrame': '0th, 7th and 30th days.', 'description': 'Concentration of GSH in GCF was measured before (0 day) and twice after the applied treatments (7th and 30th days). GCF was taken via the intracervical absorption technique. Control GCF (from mirror-positioned health teeth) was taken once before the treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dental restorations', 'gingival crevicular fluid', 'glutathione', 'lipid peroxidation', 'superoxide dismutase'], 'conditions': ['Pharmacological Action']}, 'referencesModule': {'references': [{'pmid': '29563418', 'type': 'BACKGROUND', 'citation': 'Khurshid Z, Mali M, Naseem M, Najeeb S, Zafar MS. Human Gingival Crevicular Fluids (GCF) Proteomics: An Overview. Dent J (Basel). 2017 Feb 22;5(1):12. doi: 10.3390/dj5010012.'}, {'pmid': '29328596', 'type': 'BACKGROUND', 'citation': 'Stefanovic V, Taso E, Petkovic-Curcin A, Dukic M, Gardasevic M, Rakic M, Xavier S, Jovic M, Miller K, Stanojevic I, Vojvodic D. Influence of dental filling material type on the concentration of interleukin 9 in the samples of gingival crevicular fluid. Vojnosanit Pregl. 2016 Aug;73(8):728-34. doi: 10.2298/VSP140227054S.'}, {'pmid': '12021246', 'type': 'BACKGROUND', 'citation': 'Gaut JP, Byun J, Tran HD, Lauber WM, Carroll JA, Hotchkiss RS, Belaaouaj A, Heinecke JW. Myeloperoxidase produces nitrating oxidants in vivo. J Clin Invest. 2002 May;109(10):1311-9. doi: 10.1172/JCI15021.'}, {'pmid': '22721943', 'type': 'BACKGROUND', 'citation': 'Djukic MM, Jovanovic MD, Ninkovic M, Stevanovic I, Ilic K, Curcic M, Vekic J. Protective role of glutathione reductase in paraquat induced neurotoxicity. Chem Biol Interact. 2012 Aug 30;199(2):74-86. doi: 10.1016/j.cbi.2012.05.008. Epub 2012 Jun 18.'}, {'pmid': '28102089', 'type': 'BACKGROUND', 'citation': 'Begic A, Djuric A, Ninkovic M, Stevanovic I, Djurdjevic D, Pavlovic M, Jelic K, Pantelic A, Zebic G, Dejanovic B, Stanojevic I, Vojvodic D, Milosavljevic P, Djukic M, Saso L. Disulfiram moderately restores impaired hepatic redox status of rats subchronically exposed to cadmium. J Enzyme Inhib Med Chem. 2017 Dec;32(1):478-489. doi: 10.1080/14756366.2016.1261132.'}, {'pmid': '28344087', 'type': 'BACKGROUND', 'citation': 'Djuric A, Begic A, Gobeljic B, Pantelic A, Zebic G, Stevanovic I, Djurdjevic D, Ninkovic M, Prokic V, Stanojevic I, Vojvodic D, Djukic M. Subacute alcohol and/or disulfiram intake affects bioelements and redox status in rat testes. Food Chem Toxicol. 2017 Jul;105:44-51. doi: 10.1016/j.fct.2017.03.041. Epub 2017 Mar 24.'}, {'pmid': '28074077', 'type': 'BACKGROUND', 'citation': 'Nazar Majeed Z, Philip K, Alabsi AM, Pushparajan S, Swaminathan D. Identification of Gingival Crevicular Fluid Sampling, Analytical Methods, and Oral Biomarkers for the Diagnosis and Monitoring of Periodontal Diseases: A Systematic Review. Dis Markers. 2016;2016:1804727. doi: 10.1155/2016/1804727. Epub 2016 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the study was to ascertain the influence of dental caries and teeth position as well as the type and amount of the applied dental materials (DMs) on the oxidative stress (OS) status in gingival crevicular fluid (GCF).', 'detailedDescription': 'Six DMs were tested by investigators, each sealed in one session: amalgam (Amg), zinc phosphate cement (ZnPhC), zinc polycarboxylate cement (ZnPoC), glass ionomer cement (GIC) and composites, Tetric EvoCeram (TEC) and Beautifil (BF).\n\nThe study included 88 dental outpatients. Oxidative stress parameters, including malondialdehyde (MDA), glutathione (GSH) and total superoxide dismutase (tSOD) activity were measured in GCF, before (day 0) and after treatment (7th and 30th day).\n\nAntagonistically positioned healthy teeth were used as a control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCriteria related to the condition of teeth:\n\n* Presence of proximal caries on anterior and posterior teeth\n* Existence of the antagonistic tooth ("mirror"-positioned healthy tooth) to be used as control\n* An absence of fresh post-extraction or traumatic wounds in the restoration area or in the area of restored surfaces\n* An absence of infection in the area of restored surfaces\n\nOther influencing criteria:\n\n* Absence of bone-associated diseases or treatments\n* Satisfactory oral hygiene\n* Patients exhibiting good compliance\n\nExclusion Criteria:\n\nCriteria related to the condition of teeth:\n\n* Endodontic and/or periodontal infections in the area of the cervical filling\n* Presence of periodontopathy\n* Prominent periodontal pockets\n* Subgingival carries\n* Prominent fillings outside the cavity\n\nOther influencing criteria:\n\n* Patients on radiation or immunosuppressive therapy\n* Presence of bone-associated diseases and malignant diseases\n* Patients using drugs/alcohol/cigarettes (\\> 20 cigarettes per day)\n* Bad oral hygiene\n* Patients exhibiting poor compliance'}, 'identificationModule': {'nctId': 'NCT03522532', 'briefTitle': 'Dental Restorations Effect on Oxidative Status of the Gingival Crevicular Fluid', 'organization': {'class': 'OTHER', 'fullName': 'Military Medical Academy, Belgrade, Serbia'}, 'officialTitle': 'Redox Interactions Between Dental Restorations and Gingival Crevicular Fluid', 'orgStudyIdInfo': {'id': 'VMA/10-12/A.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amalgam (Amg)', 'description': 'Amalgam was sealed in 8-K2 patients and 6-K2 patients. Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.', 'interventionNames': ['Procedure: Amalgam placement']}, {'type': 'EXPERIMENTAL', 'label': 'Tetric EvoCeram (TEC)', 'description': 'Tetric EvoCeram was sealed in 12-K2 patients and 5-K5 patients. Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.', 'interventionNames': ['Procedure: Tetric EvoCeram placement']}, {'type': 'EXPERIMENTAL', 'label': 'Beautifil (BF)', 'description': 'Beautifil was sealed in 15-K2 patients. Oxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.', 'interventionNames': ['Procedure: Beautifil placement']}, {'type': 'EXPERIMENTAL', 'label': 'Zinc phosphate cement (ZPhC)', 'description': 'Zinc phosphate cement was sealed in 7-K2 patients, 4-K3 patients, 1-K4 patients and 2-K5 patients.\n\nOxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.', 'interventionNames': ['Procedure: Zinc phosphate cement placement']}, {'type': 'EXPERIMENTAL', 'label': 'Zinc polycarboxylate cement (ZPoC)', 'description': 'Zinc polycarboxylate cement was sealed in 5-K2 patients, 4-K3 patients and 5-K4 patients.\n\nOxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.', 'interventionNames': ['Procedure: Zinc polycarboxylate cement placement']}, {'type': 'EXPERIMENTAL', 'label': 'Glass ionomer cement (GIC)', 'description': 'Glass ionomer cement was sealed in 11-K2 patients, 2-K3 patients and 1-K5 patients.\n\nOxidative stress parameters (MDA, GSH, tSOD) were measured in GCF prior to treatment and on the 7th and 30th day after treatment.', 'interventionNames': ['Procedure: Glass ionomer cement placement']}], 'interventions': [{'name': 'Amalgam placement', 'type': 'PROCEDURE', 'description': 'Before the Amg was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.', 'armGroupLabels': ['Amalgam (Amg)']}, {'name': 'Tetric EvoCeram placement', 'type': 'PROCEDURE', 'description': 'Before the TEC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.', 'armGroupLabels': ['Tetric EvoCeram (TEC)']}, {'name': 'Beautifil placement', 'type': 'PROCEDURE', 'description': 'Before the BF was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.', 'armGroupLabels': ['Beautifil (BF)']}, {'name': 'Zinc phosphate cement placement', 'type': 'PROCEDURE', 'description': 'Before the ZPhC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.', 'armGroupLabels': ['Zinc phosphate cement (ZPhC)']}, {'name': 'Zinc polycarboxylate cement placement', 'type': 'PROCEDURE', 'description': 'Before the ZPoC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.', 'armGroupLabels': ['Zinc polycarboxylate cement (ZPoC)']}, {'name': 'Glass ionomer cement placement', 'type': 'PROCEDURE', 'description': 'Before the GIC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.', 'armGroupLabels': ['Glass ionomer cement (GIC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Military Medical Academy', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'overallOfficials': [{'name': 'Mirjana M Djukic, PhD, Pharm.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Belgrade'}, {'name': 'Danilo V Vojvodic', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Military Medical Academy, Belgrade'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ervin Taso', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Belgrade', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ervin Taso', 'investigatorAffiliation': 'Military Medical Academy, Belgrade, Serbia'}}}}