Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-30 @ 11:09 AM
Study NCT ID:
NCT06264869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interdental Guided Creeping Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Black triangle height', 'timeFrame': 'Baseline, 1, 3 and 6 months.', 'description': 'In mm'}], 'secondaryOutcomes': [{'measure': 'Percentage of interdental papillary fill', 'timeFrame': 'Baseline, 1, 3 and 6 months.', 'description': 'In %'}, {'measure': 'Papillary gain, black triangle reduction', 'timeFrame': 'Baseline, 1, 3 and 6 months.', 'description': 'In mm, %'}, {'measure': 'Papillary height, attached gingiva width', 'timeFrame': 'Baseline, 1, 3 and 6 months.', 'description': 'In mm'}, {'measure': 'Pocket depth, clinical attachment level, keratinized tissue thickness', 'timeFrame': 'Baseline, 3 and 6 months.', 'description': 'In mm'}, {'measure': 'Plaque index', 'timeFrame': 'Baseline, 1, 3 and 6 months.', 'description': 'Scores'}, {'measure': 'Gingival index', 'timeFrame': 'Baseline, 1, 3 and 6 months.', 'description': 'Scores'}, {'measure': 'Duration of surgery', 'timeFrame': 'At time of surgery', 'description': 'In minutes'}, {'measure': 'Patient Reported Outcome', 'timeFrame': 'At the day of surgery and the 1st 10 days postoperative.', 'description': 'VAS score for pain'}, {'measure': 'Patient Reported Outcome', 'timeFrame': '1, 3 and 6 months.', 'description': 'Patient satisfaction (score)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interdental papilla loss', 'Interdental papilla deficiency', 'Interdental papilla recession', 'Black triangle', 'Connective tissue graft', 'Collagen membrane', 'Minimally Invasive Surgery', 'Tunneling Techniques', 'Creeping Attachment', 'Plastic periodontal surgery'], 'conditions': ['Interdental Papilla Recession']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy patients having interdental papilla deficiency.\n* Good Oral Hygiene.\n* Age range: 18 - 50 years.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Smokers.\n* Alcoholic patients and drug abusers.\n* Handicapped and prisoners.'}, 'identificationModule': {'nctId': 'NCT06264869', 'briefTitle': 'Interdental Guided Creeping Technique', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'A Novel Approach of Interdental Guided Creeping Technique (IGCT) for Augmentation of Deficient Interdental Papillae: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '141123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IGCT + CTG', 'description': 'Interdental guided creeping technique (IGCT) + Connective tissue graft (CTG)', 'interventionNames': ['Procedure: Interdental guided creeping technique (IGCT) and connective tissue graft (CTG)']}, {'type': 'EXPERIMENTAL', 'label': 'IGCT + CM', 'description': 'Interdental guided creeping technique (IGCT) + Collagen membrane (CM)', 'interventionNames': ['Procedure: Interdental guided creeping technique (IGCT) and collagen membrane (CM)']}], 'interventions': [{'name': 'Interdental guided creeping technique (IGCT) and connective tissue graft (CTG)', 'type': 'PROCEDURE', 'description': 'Interdental guided creeping technique (IGCT) and connective tissue graft (CTG)', 'armGroupLabels': ['IGCT + CTG']}, {'name': 'Interdental guided creeping technique (IGCT) and collagen membrane (CM)', 'type': 'PROCEDURE', 'description': 'Interdental guided creeping technique (IGCT) and collagen membrane (CM)', 'armGroupLabels': ['IGCT + CM']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gamal', 'role': 'CONTACT', 'email': 'hgamal1@hotmail.com', 'phone': '01006607176'}, {'name': 'A.GamalElDin', 'role': 'CONTACT', 'email': 'g.ag.ghada@gmail.com'}], 'overallOfficials': [{'name': 'Ghada G A.GamalElDin, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PhD Student of Periodontology, Faculty of Dentistry, Cairo University'}, {'name': 'Mohamed S. Morgan, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Master Student of Periodontology, Faculty of Dentistry, Ain Shams University'}, {'name': 'Ahmed Y Gamal, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Oral Medicine, Periodontology and Oral Diagnosis - Faculty of Dentistry - Ain Shams University, Professor of Periodontology - College of Oral and Dental Surgery - Misr University for Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Ain Shams University. Professor of Periodontology, College of Oral and Dental Surgery, Misr University for Science and Technology.', 'investigatorFullName': 'Ahmed Y Gamal', 'investigatorAffiliation': 'Ain Shams University'}}}}