Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:37 PM
Study NCT ID:
NCT03590093
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2018-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The examiner were not aware of group allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2018-07-04', 'studyFirstSubmitQcDate': '2018-07-17', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of C Reactive Protein (CRP) at 24 hour', 'timeFrame': 'Collected at Baseline and 24 hours in order to calculate the changes', 'description': 'CRP analyzed though blood sampling. Unit of measure: mg/L'}], 'secondaryOutcomes': [{'measure': 'Glucose', 'timeFrame': 'Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment', 'description': 'analyzed though blood sampling. Unit of measure: mg/dL'}, {'measure': 'Cholesterol', 'timeFrame': 'Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment', 'description': 'analyzed though blood sampling. Unit of measure: mg/dL'}, {'measure': 'Triglycerides', 'timeFrame': 'Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment', 'description': 'analyzed though blood sampling. Unit of measure: mg/dL'}, {'measure': 'HDL Cholesterol', 'timeFrame': 'Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment', 'description': 'analyzed though blood sampling. Unit of measure: mg/dL'}, {'measure': 'LDL Cholesterol', 'timeFrame': 'Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment', 'description': 'analyzed though blood sampling. Unit of measure: mg/dL'}, {'measure': 'Fibrinogen', 'timeFrame': 'Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment', 'description': 'analyzed though blood sampling. Unit of measure: mg/dL'}, {'measure': 'D-Dimer', 'timeFrame': 'Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment', 'description': 'analyzed though blood sampling. Unit of measure: mg/L'}, {'measure': 'Cystatin C', 'timeFrame': 'Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment', 'description': 'analyzed though blood sampling. Unit of measure: mg/L'}, {'measure': 'C Reactive Protein (CRP)', 'timeFrame': 'Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment', 'description': 'CRP analyzed though blood sampling. Unit of measure: mg/L'}, {'measure': 'Clinical attachment level (CAL) at deepest site', 'timeFrame': 'Measured at Baseline and 6 months after treatment', 'description': 'Changes in CAL , measured orally through clinical examination. Unit of measure: mm'}, {'measure': 'Pocket probing depth (PPD) at deepest site', 'timeFrame': 'Measured at Baseline and 6 months after treatment', 'description': 'Changes in PPD , measured orally through clinical examination. Unit of measure: mm'}, {'measure': 'Recession of the gingival margin (REC)', 'timeFrame': 'Measured at Baseline and 6 months after treatment', 'description': 'Changes in REC, measured orally through clinical examination. Unit of measure: mm'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Diseases']}, 'referencesModule': {'references': [{'pmid': '32163634', 'type': 'DERIVED', 'citation': 'Graziani F, Peric M, Marhl U, Petrini M, Bettini L, Tonetti M, Gennai S. Local application of enamel matrix derivative prevents acute systemic inflammation after periodontal regenerative surgery: A randomized controlled clinical trial. J Clin Periodontol. 2020 Jun;47(6):747-755. doi: 10.1111/jcpe.13270. Epub 2020 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare surgical treatment of periodontal infrabony defects with and without the adjunct of an enemal matrix derivative (EMD) in terms of acute-phase responses, in systemic healthy patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Good health\n* No previous periodontal surgical treatment\n* Indication for periodontal surgery (intrabony defects to be at least 4 mm deep)\n* Ability to understand the study procedures and comply with them through the length of the study\n\nExclusion Criteria:\n\n* Pregnancy, breast feeding or taking oral contraceptive (all non-drug contraceptives will be allowed)\n* The need for antibiotic therapy to undergo periodontal therapy\n* Chronic infections\n* Systemic diseases\n* Patients who report current smoking over 20 cigarettes per day or pipe or cigar'}, 'identificationModule': {'nctId': 'NCT03590093', 'acronym': 'PERIOEMD-1', 'briefTitle': 'Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': 'Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Surgical Therapy', 'orgStudyIdInfo': {'id': '3649/13A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Periodontal Surgery with EMD', 'description': 'A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. After carefully cleaning root dental surfaces, EMD was placed inside the infrabony periodontal defect. Suture were placed to maintain wound stability.', 'interventionNames': ['Procedure: Periodontal surgery', 'Procedure: EMD application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Periodontal Surgery', 'description': 'A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. Suture were placed to maintain wound stability.', 'interventionNames': ['Procedure: Periodontal surgery']}], 'interventions': [{'name': 'Periodontal surgery', 'type': 'PROCEDURE', 'otherNames': ['Open Flap Debridement'], 'description': 'After local anesthesia injection an intrasulcular flap is designed according to minimally invasive techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed.', 'armGroupLabels': ['Periodontal Surgery', 'Periodontal Surgery with EMD']}, {'name': 'EMD application', 'type': 'PROCEDURE', 'otherNames': ['Amelogenins application'], 'description': 'Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface', 'armGroupLabels': ['Periodontal Surgery with EMD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56126', 'city': 'Pisa', 'country': 'Italy', 'facility': 'University Hospital of Pisa', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut Straumann AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Filippo Graziani, DDS MClinDent PhD', 'investigatorAffiliation': 'University of Pisa'}}}}