Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-14 @ 2:12 PM
Study NCT ID:
NCT06528327
Status:
COMPLETED
Last Update Posted:
2024-07-30
First Post:
2024-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioactive Microstructured Anti Microbial Precoated Surface Implant Versus Non-coated Surface Implant in Type 2 Diabetic Patients in the Mandible
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Split Mouth Design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-25', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in implant stability', 'timeFrame': 'up to 4 months', 'description': 'implant stability will be assessed using Osstell device'}, {'measure': 'change in pain intensity', 'timeFrame': '1st,3rd, and 7th days', 'description': 'pain was assessed using visual analogue scale that ranges from 0 (No pain) to 10 (untolerated pain)'}, {'measure': 'Wound Healing score', 'timeFrame': '1st,3rd, and 7th days,14th day', 'description': 'Landry healing index was used;\n\n1. Very poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue:Present, Incision margin: Not epithelialized, with loss ofepithelium beyond incision margin, Suppuration: Present\n2. Poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue: Present, Incision margin: Not epithelialized, with connective tissue exposed\n3. Good Tissue colour: ≥25% and\\<50% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed\n4. Very good Tissue colour: \\<25% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed\n5. Excellent Tissue color: All tissues pink, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue expose'}], 'secondaryOutcomes': [{'measure': 'Post operative complications', 'timeFrame': '6 months', 'description': 'Occurence of infection was assessed'}, {'measure': 'Change in bone density', 'timeFrame': 'up to 4 months', 'description': 'CBCT was used to measure bone density'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Implant', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': "Dental implant's surface properties significantly influence both biological and mechanical integration. Surface bio-treatment could accelerate and enhance bone regeneration, ensuring successful implantation. therefore, this study compares bone densification, primary and secondary stability, wound healing, and pain intensity between pre-coated antimicrobial surfaces of dental implants versus non-coated surfaces in controlled type 2 diabetic patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adequate interproximal space.\n* Adequate interocclusal space.\n* Adequate anatomical location, accessibility, and visualization for easy surgical implant placement.\n* Both genders.\n* Controlled medical condition\n\nExclusion Criteria:\n\n* Presence of parafunctional dependency as bruxism.\n* Adjacent pathosis near the implant site.\n* Patient under radiotherapy targeting the head and neck.\n* Heavy smokers.'}, 'identificationModule': {'nctId': 'NCT06528327', 'briefTitle': 'Bioactive Microstructured Anti Microbial Precoated Surface Implant Versus Non-coated Surface Implant in Type 2 Diabetic Patients in the Mandible', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Bioactive Microstructured Anti Microbial Precoated Surface Implant Versus Non-coated Surface Implant in Type 2 Diabetic Patients in the Mandible (Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '0375-01/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre coated surface implants', 'interventionNames': ['Other: Pre coated impants']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non coated surface implants', 'interventionNames': ['Other: Non coated implant surface']}], 'interventions': [{'name': 'Pre coated impants', 'type': 'OTHER', 'description': 'Pre coated impants with microstructured bioactive antimicrobial coating with double threading for higher bone-to-implant contact and faster bone gathering on the surface.', 'armGroupLabels': ['Pre coated surface implants']}, {'name': 'Non coated implant surface', 'type': 'OTHER', 'description': 'Non-coated implant with double threading for higher bone-to-implant contact and faster bone gathering on the surface.', 'armGroupLabels': ['Non coated surface implants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Dental Public Health and biostatistical consultanat', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}