Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-26 @ 11:16 AM
Study NCT ID:
NCT01860495
Status:
COMPLETED
Last Update Posted:
2013-05-22
First Post:
2013-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gingival Crevicular Fluid Bone Morphogenetic Protein - 2 Release Profile Following the Use of Perforated Membrane
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010514', 'term': 'Periodontal Pocket'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-21', 'studyFirstSubmitDate': '2013-05-19', 'studyFirstSubmitQcDate': '2013-05-21', 'lastUpdatePostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gingival cervicular fluid BMP-2 level', 'timeFrame': '30 days', 'description': 'Using capillary tube (5 µl), gingival cervicular fluid (GCF) samples were collected (Sueda et al, 1969) by a single examiner (MA) who was masked to the attribution of the sites to MPM or OM. Following the isolation and drying of the selected site with cotton rolls, a fisher brand disposable micropipettes €, placed intrasulculary at the mesiofacial line angle of the selected site to a maximum depth of 2 mm below the gingival margin. Micropipettes were left in place until 5ul of fluid was collected. Gingival cervicular fluid (GCF) samples were collected one day, 3, 7, 14, 21, and 30 days after therapy and diluted in saline solution (50 µl) for bone morphogenetic protein-2 level evaluation. Samples were labeled, carried in a dark container and kept at -80 C until used.'}], 'secondaryOutcomes': [{'measure': 'intrabony components (defect bony filling)', 'timeFrame': '9 months', 'description': 'Clinical and radiographic measurements (pocket depth, attachement level, gingival index , plaque index, intrabony level) were reassessed at 3, 6, and 9 months after surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['growth factors', 'periodontal pockets'], 'conditions': ['Periodontal Pocket']}, 'referencesModule': {'references': [{'pmid': '23003916', 'type': 'RESULT', 'citation': 'Gamal AY, Iacono VJ. Enhancing guided tissue regeneration of periodontal defects by using a novel perforated barrier membrane. J Periodontol. 2013 Jul;84(7):905-13. doi: 10.1902/jop.2012.120301. Epub 2012 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'One of the most important elements suggested to be provided through membrane perforations to augment regeneration are cell released growth factors from the overlying periosteal and gingival cells. A direct correlation could exist between the number of such cells and their available released growth factors. To test this assumption, this study was designed to evaluate levels of bone morphogenetic protein-2 in gingival crevicular fluid (GCF) during the early stages of healing for sites treated by MPM compared to that of the occlusive barrier membranes.', 'detailedDescription': 'The subjects were recruited consecutively from the list of patients seeking care for periodontal problems at the Department of Periodontology of the Faculty of Dental Medicine, Al Azhar University, Cairo, Egypt, between March 2012 to December 2012. The criteria implemented for patient inclusion were: 1) no systemic diseases which could influence the outcome of the therapy; 2) good compliance with the plaque control instructions following initial therapy; 3) teeth involved were all vital with score 0 mobility ; 4) each subject contributed matched pairs of two or three walled intrabony interproximal defects in premolar or molar teeth 5) the selected 2- or 3-wall intrabony defect depth ranged from 3-5 mm as detected in diagnostic periapical radiographs; 6) selected pocket depth (PD) ≥ 6 mm and clinical attachment level (CAL) ≥ 5 mm at the site of endosseous defect four weeks following initial cause-related therapy 7) endosseous radiographic defect angle ≤55 and ≥15 8) availability for the follow-up and maintenance program; 9) absence of periodontal treatment for the previous year; 10) absence of systemic medication or antibiotic treatment for the previous 6 months; 11) absence of a smoking habit and 12) absence of occlusal interferences. Pregnant females were excluded from participating in the study. Patients were also excluded from the study if they presented with opened interproximal contact, or inadequate compliance with the oral hygiene maintenance schedule. The experimental protocol was approved by the Ethical Committee of El Azhar University (OMD - 45 - 2012, clinical trial registration number: Al Azhar University 22-31). Research procedures were explained to all patients and they agreed to participate in the study and signed the appropriate informed consent form of Al Azhar University.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '51 Years', 'minimumAge': '31 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Fifteen non-smoking patients (8 males and 7 females) who were 31 to 51 years of age at the time of baseline examination (mean age 33.8 ± 6.1) with severe chronic periodontitis (Armitage 1999) participated in this prospective, randomized and blinded clinical trial. The subjects were recruited consecutively from the list of patients seeking care for periodontal problems at the Department of Periodontology of the Faculty of Dental Medicine, Al Azhar University, Cairo, Egypt, between March 2012 to December 2012. The experimental protocol was approved by the Ethical Committee of El Azhar University (OMD - 45 - 2012). Research procedures were explained to all patients and they agreed to participate in the study and signed the appropriate informed consent form of Al Azhar University.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. no systemic diseases which could influence the outcome of the therapy;\n2. good compliance with the plaque control instructions following initial therapy;\n3. teeth involved were all vital with score 0 mobility ;\n4. each subject contributed matched pairs of two or three walled intrabony interproximal defects in premolar or molar teeth\n5. the selected 2- or 3-wall intrabony defect depth ranged from 3-5 mm as detected in diagnostic periapical radiographs;\n6. selected pocket depth (PD) ≥ 6 mm and clinical attachment level (CAL) ≥ 5 mm at the site of endosseous defect four weeks following initial cause-related therapy\n7. endosseous radiographic defect angle ≤55 and ≥15\n8. availability for the follow-up and maintenance program;\n9. absence of periodontal treatment for the previous year;\n10. absence of systemic medication or antibiotic treatment for the previous 6 months;\n11. absence of a smoking habit and\n12. absence of occlusal interferences.\n\nExclusion Criteria:\n\n* Pregnant females were excluded from participating in the study.\n* Patients were also excluded from the study if they presented with opened interproximal contact, or inadequate compliance with the oral hygiene maintenance schedule.'}, 'identificationModule': {'nctId': 'NCT01860495', 'acronym': 'MPM', 'briefTitle': 'Gingival Crevicular Fluid Bone Morphogenetic Protein - 2 Release Profile Following the Use of Perforated Membrane', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Gingival Crevicular Fluid Bone Morphogenetic Protein - 2 Release Profile Following the Use of Modified Perforated Membrane Barriers in Localized Intrabony Defects (An in Vivo Study)', 'orgStudyIdInfo': {'id': 'ahmedgamal'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'perforated membrane group', 'description': 'perforated membrane group (G1- 15 sites)', 'interventionNames': ['Procedure: perforated membrane']}, {'label': 'occlusive membrane group', 'description': 'occlusive collagen membrane that are tradetionally used in guided tissue regeneration , control occlusive group (G2-15 sites)', 'interventionNames': ['Procedure: G2']}], 'interventions': [{'name': 'perforated membrane', 'type': 'PROCEDURE', 'otherNames': ['collagen membranes'], 'description': 'perforated membrane that could give a chance for posetive contributionn of periosteal and gingival mesenchymal stem cells in periodontal regeneration', 'armGroupLabels': ['perforated membrane group']}, {'name': 'G2', 'type': 'PROCEDURE', 'otherNames': ['guided tissue membranes'], 'description': 'tradetional occlusive collagen membrane', 'armGroupLabels': ['occlusive membrane group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1123', 'city': 'Cairo Governorate', 'state': 'Egypt', 'country': 'Egypt', 'facility': 'Al azhar universty'}], 'overallOfficials': [{'name': 'Ahmed Y Gamal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al Azhar universty, faculty of dentistry, cairo, egypt'}, {'name': 'Mohamed M Aziz, BCH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'al azhar universty, cairo, egypt'}, {'name': 'Mohamed M Helmy, MSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'al azhar universty'}, {'name': 'Vencint J Iacono, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Stony Brook Uiversty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of periodontology', 'investigatorFullName': 'Ahmed Y Gamal', 'investigatorAffiliation': 'Al-Azhar University'}}}}