Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT04833569
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2021-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ICG-PDT, Periimplantitis, Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057873', 'term': 'Peri-Implantitis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-04', 'studyFirstSubmitDate': '2021-03-30', 'studyFirstSubmitQcDate': '2021-04-04', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding on probing', 'timeFrame': '6 months', 'description': "Presence or absence of bleeding indicated as '1' or '0', respectively"}, {'measure': 'Plaque index', 'timeFrame': '6 months', 'description': "Presence or absence of plaque indicated as '1' or '0', respectively."}, {'measure': 'Probing depth', 'timeFrame': '6 months', 'description': 'Measurement of consecutive millimeter markings of the periodontal pocket depth'}, {'measure': 'Suppuration', 'timeFrame': '6 months', 'description': 'Presence or absence of pus'}, {'measure': 'Crestal bone loss', 'timeFrame': '6 months', 'description': 'Measurement of consecutive millimeter markings of the alveolar bone levels'}], 'secondaryOutcomes': [{'measure': 'Microbiological analysis (Porphyromonas gingivalis)', 'timeFrame': '6 months', 'description': 'Bacterial viability from the peri-implant plaque'}, {'measure': 'Microbiological analysis (Treponema denticola)', 'timeFrame': '6 months', 'description': 'Bacterial viability from the peri-implant plaque'}, {'measure': 'HbA1c', 'timeFrame': '6 months', 'description': 'Assessment of serum HbA1c'}, {'measure': 'Interleukin-1 beta', 'timeFrame': '6 months', 'description': 'Assessment from peri-implant crevicular fluid'}, {'measure': 'Interleukin-6', 'timeFrame': '6 months', 'description': 'Assessment from peri-implant crevicular fluid'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['photodynamic therapy*', 'periimplantitis*', 'diabetes mellitus*', 'indocyanine green*', 'photosensitizer*'], 'conditions': ['Peri-Implantitis']}, 'referencesModule': {'references': [{'pmid': '34033934', 'type': 'DERIVED', 'citation': 'Labban N, Shibani NA, Al-Kattan R, Alfouzan AF, Binrayes A, Assery MK. Clinical, bacterial, and inflammatory outcomes of indocyanine green-mediated photodynamic therapy for treating periimplantitis among diabetic patients: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2021 Sep;35:102350. doi: 10.1016/j.pdpdt.2021.102350. Epub 2021 May 24.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the effect of photodynamic therapy (indocyanine green mediated) on the clinical, biological and inflammatory aspects was assessed in diabetic patients having peri-implantitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* Inclusion Criteria:\n\n * adult patients above 45 years of age having type 2 DM\n * HbA1c (≥6.5%) and fasting glucose test\n * probing depth ≥6 mm with bleeding and/or suppuration on at least one site around dental implants that remained in situ\n * On radiographic assessment, the implants exhibited ≥ 3 mm alveolar bone loss apical to the coronal region of the intraosteal portion of the dental implant.\n* Exclusion Criteria Patients were excluded if they indicated current or former history of tobacco smoking, any systemic disease other than DM, enrolled in a non-surgical periodontal maintenance program, history of implant repair, pregnancy, and part six months use of antimicrobials, non-steroidal anti-inflammatory drugs, bisphosphonates, or corticosteroids.'}, 'identificationModule': {'nctId': 'NCT04833569', 'briefTitle': 'ICG-PDT, Periimplantitis, Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'King Saud University'}, 'officialTitle': 'Clinical, Bacterial, and Inflammatory Outcomes of Indocyanine Green-mediated Photodynamic Therapy for Treating Periimplantitis Among Diabetic Patients: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'KingSaud'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Indocyanine green mediated photodynamic therapy (ICG-PDT)', 'description': 'Delivery of ICG solution at a concentration of 1 mg/mL will be used. The photosensitizer will be applied until the bottom of the peri-implant pocket using a 1 ml syringe. An 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J will be used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction.', 'interventionNames': ['Biological: ICG-PDT', 'Device: peri-implant mechanical debridement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Peri-implant mechanical debridement', 'description': 'Non-surgical peri-implant mechanical debridement (PIMD) through ultrasonic device with a carbon tip.', 'interventionNames': ['Device: peri-implant mechanical debridement']}], 'interventions': [{'name': 'ICG-PDT', 'type': 'BIOLOGICAL', 'description': "An 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J was used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction. The treatment was applied according to the manufacturer's recommendation. The PDT was performed by a single operator in all test patients", 'armGroupLabels': ['Indocyanine green mediated photodynamic therapy (ICG-PDT)']}, {'name': 'peri-implant mechanical debridement', 'type': 'DEVICE', 'description': 'The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).', 'armGroupLabels': ['Indocyanine green mediated photodynamic therapy (ICG-PDT)', 'Peri-implant mechanical debridement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11564', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Saud University', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Nawwaf Labban, BDS MSD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Saud University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University', 'investigatorFullName': 'Labban Nawwaf', 'investigatorAffiliation': 'King Saud University'}}}}