Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT05976451
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2023-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Time Effect on the Predictability of Different Grafting for Gingival Recession RT 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2023-03-12', 'studyFirstSubmitQcDate': '2023-07-27', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'interproximal clinical attachment level', 'timeFrame': '6-9 months', 'description': 'measured from CEJ to base of pocket depth by using periodontal prob'}, {'measure': 'Probing pocket depth (PPD)', 'timeFrame': '6-9 months', 'description': 'from gingival margin to pocket depth measured by mm'}, {'measure': 'Recession depth', 'timeFrame': '6-9 months', 'description': 'measure from CEJ to gingival margin by mm'}], 'secondaryOutcomes': [{'measure': 'Keratinized tissue width', 'timeFrame': '6-9 months', 'description': 'from free gingival groove to MGJ'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gingival Recession Types One(RT1)']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession (MAGR) in recession type one (RT1)', 'detailedDescription': 'this study was conducted to evaluate time effect on the clinical predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent gingival recession'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of RT1 GRs of the maxillary or mandibular arch in the esthetic zone with a GR depth ≥2 mm,\n* patients \\>18 years old,\n* Full mouth plaque index score \\<20%\n* Systemically and periodontally healthy patients.\n\nExclusion Criteria:\n\n* Smokers\n* Patients with periodontitis stage III and IV were previous surgical treatment of GR,\n* Pregnant or breastfeeding women; P\n* Patients with para-functional habits or any source of occlusal trauma.'}, 'identificationModule': {'nctId': 'NCT05976451', 'briefTitle': 'Time Effect on the Predictability of Different Grafting for Gingival Recession RT 1', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Time Effect on the Predictability of Different Grafting Materials in Treatment of Gingival Recession RT 1in the Esthetic Zone', 'orgStudyIdInfo': {'id': '1011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'collagen matrix', 'description': 'melatonin in collagen matrix with Modified Coronally Advanced Tunneling Technique (MCAT)', 'interventionNames': ['Combination Product: melatonin with collagen matrix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'connective tissue graft (CTG)', 'description': 'connective tissue graft with Modified Coronally Advanced Tunneling Technique (MCAT)', 'interventionNames': ['Combination Product: connective tissue graft (CTG)']}], 'interventions': [{'name': 'melatonin with collagen matrix', 'type': 'COMBINATION_PRODUCT', 'description': '(CMX) with melatonin in the esthetic zone using Modified Coronally Advanced Tunneling Technique (MCAT)', 'armGroupLabels': ['collagen matrix']}, {'name': 'connective tissue graft (CTG)', 'type': 'COMBINATION_PRODUCT', 'description': 'control group connective tissue graft using Modified Coronally Advanced Tunneling Technique (MCAT)', 'armGroupLabels': ['connective tissue graft (CTG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'mahetab mohamed abdel el wahab', 'investigatorAffiliation': 'Ain Shams University'}}}}