Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-24 @ 9:46 PM
Study NCT ID:
NCT05782751
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2023-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth Factor Enhanced Matrix With Subepithelial Connective Tissue Graft or Collagen Membrane in Treatment of Gingival Recession
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005889', 'term': 'Gingival Recession'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recession width', 'timeFrame': 'up to 6 months', 'description': 'the distance between the mesial and distal papillae along the CEJ measured at baseline , 1, 3, and 6 months'}, {'measure': 'recession depth', 'timeFrame': 'up to 6 months', 'description': 'The distance between the CEJ and the gingival margin at the midbuccal aspect of the involved tooth measured at baseline , 1, 3, and 6 months'}, {'measure': 'Height of keratinized tissue', 'timeFrame': 'up to 6 months', 'description': 'distance from the most apical point of the free gingival margin to the mucogingival junction mid-facially measured at baseline , 1, 3, and 6 months'}, {'measure': 'Gingival thickness (Gingival biotype)', 'timeFrame': 'up to 6 months', 'description': 'measured at mid-buccal area 2 mm apical to the free gingival margin measured at baseline, and 6 months postoperatively'}, {'measure': 'radiographic measurements of facial bone level, thickness and density', 'timeFrame': 'up to 6 months', 'description': 'from cone beam CT radiography measured at baseline, and 6 months postoperative'}, {'measure': 'Percentage of root coverage', 'timeFrame': 'up to 6 months', 'description': 'according to the following formula: (RD at baseline - RD at 6 months) / RD at baseline)x100 was calculated after 6 months'}], 'secondaryOutcomes': [{'measure': 'probing pocket depth', 'timeFrame': 'up to 6 months', 'description': 'measured from gingival margin to the bottom of the pocket measured at baseline, 3, and 6 months'}, {'measure': 'clinical attachment level', 'timeFrame': 'up to 6 months', 'description': 'measured from CEJ to the bottom of the pocket measured at baseline, 3, and 6 months'}, {'measure': 'Digital measurements', 'timeFrame': 'up to 6 months', 'description': 'all recession areas were photographed The photos were taken by a digital camera at a fixed resolution (mega pixel) taken at baseline, 1,3,and 6 months postoperative'}, {'measure': 'healing index', 'timeFrame': 'up to 6 months', 'description': 'recorded at 1, 3 and 6 months postoperatively (Score 1: uneventful healing while score 3: poor wound healing'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Gingival recession', 'free subepithelial connective tissue graft', 'collagen membrane', 'growth factor enhanced matrix 21 s'], 'conditions': ['GINGIVAL RECESSION']}, 'descriptionModule': {'briefSummary': 'The study aimed to compare, the effectiveness of Growth Factor Enhanced Matrix (GEM 21s) ® combined either with free connective tissue graft or collagen membrane in the treatment of Miller class II gingival recession.', 'detailedDescription': "Materials and Methods: Twenty sites in 10 patients, with class II Miller gingival recession were allocated randomly to be treated by (GEM 21s) ® with free connective tissue graft (groupI) or GEM 21s with collagen membrane (groupII). Plaque index, bleeding on probing, recession width, recession depth, height of keratinized tissue and digital measurements were recorded at baseline, 1, 3 and 6-months'. Probing pocket depth, clinical attachment level, gingival thickness and Radiographic parameters were recorded at baseline and 6 months'. Root coverage percentage were recorded 6 months postoperative and wound healing index were recorded at 1,3 and 6-months' post-operative ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lack of any related medical issues that contraindicate periodontal surgery,\n* optimum adherence as confirmed by a positive attitude towards oral hygiene, and successfully showing up for treatment appointments.\n* No history of any medications in the previous six months that may interfere with periodontal surgery Gingival thickness for the selected sites should be \\> 1mm (as measured 2mm apical to gingival margin),\n* Clinical attachment level ≥ 4mm measured from cemento-enamel junction till the deepest probing depth.\n\nExclusion Criteria:\n\n* the presence of class V caries or restoration in the site to be treated,\n* previous mucogingival surgery at the selected site.\n* Teeth that are tilted, rotated, or have any occlusal abnormalities.\n* Smokers and pregnant patients were excluded from the participation.'}, 'identificationModule': {'nctId': 'NCT05782751', 'briefTitle': 'Growth Factor Enhanced Matrix With Subepithelial Connective Tissue Graft or Collagen Membrane in Treatment of Gingival Recession', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Growth Factor Enhanced Matrix Combined Either With Free Connective Tissue Graft or With Collagen Membrane in the Treatment of Miller Class II Gingival Recession', 'orgStudyIdInfo': {'id': '6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(groupI)', 'description': '10 recession sites treated by (GEM 21s) ® with free connective tissue graft', 'interventionNames': ['Procedure: GROUPI']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(groupII)', 'description': '10 recession sites GEM 21s with collagen membrane', 'interventionNames': ['Procedure: GROUP II']}], 'interventions': [{'name': 'GROUPI', 'type': 'PROCEDURE', 'otherNames': ['free connective tissue graft', 'growth factors enhanced matrix 21s (GEM21s)', 'coronally advanced flap'], 'description': '10 sites treated with Free connective tissue graft (FCTG) + growth factors enhanced matrix 21 s GEM 21S + coronally advanced flap (CAF)', 'armGroupLabels': ['(groupI)']}, {'name': 'GROUP II', 'type': 'PROCEDURE', 'otherNames': ['collagen membrane', 'coronally advanced flap'], 'description': '10 sites treated withCollagen membrane + GEM 21S + coronally advanced flap (CAF)', 'armGroupLabels': ['(groupII)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '020', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Malak Mohamed Shoukheba', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'zip': '20', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Malak Yousef Mohamed Shoukheba', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of oral medicine, oral periodontology, oral diagnosis and diagnosis', 'investigatorFullName': 'malak mohamed shoukheba', 'investigatorAffiliation': 'Tanta University'}}}}