Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT04964167
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2021-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010936', 'term': 'Plant Extracts'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-09', 'studyFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2021-07-13', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinically Evaluating the Effects of Topical Indocyanine-green Mediated Photosensitizer VS Aloe vera Gel: Adjunct therapy to Scaling and Root Planing in Patients with Chronic Periodontitis', 'timeFrame': '9 months', 'description': 'Adjunct treatment regimens PDT and AV extract significantly helped in plummeting inflammation of PD tissue'}, {'measure': 'IL-6 concentration in pg/ml', 'timeFrame': '6 months', 'description': 'Identify the concentration of IL-6 in the gingival crevicular fluid'}, {'measure': 'IL-8 concentration in pg/ml', 'timeFrame': '6 months', 'description': 'Identify the concentration of IL-8 in the gingival crevicular fluid'}, {'measure': 'TNF-α levels in pg/ml', 'timeFrame': '6 months', 'description': 'Identify the concentration of TNF-α in the gingival crevicular fluid'}, {'measure': 'Periodontal pocket depth in mm', 'timeFrame': '6 months', 'description': 'Periodontal pocket depth'}, {'measure': 'Clinical attachment loss in mm', 'timeFrame': '6 months', 'description': 'Periodontal attachment loss'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis', 'Periodontal Inflammation']}, 'descriptionModule': {'briefSummary': 'For proving the potential of tropical medicaments on clinical parameters of periodontitis, a comprehensive assessment is required between therapeutic medicaments. The main aim of the study was to clinically evaluate and compare the efficacy of indocyanine green mediated photodynamic therapy (PDT) and aleo vera (AV) extract when used as an adjunct therapy to scaling and root planning (SRP) for treatment of chronic periodontitis.\n\nOne hundred and fifty patients included in this study were randomly distributed in three treatment groups Group I (SRP), Group II (SRP+PDT) and Group III (SRP+AV). Four clinical parameters plaque index (PI), bleeding on probing (BoP), periodontal (PD) pocket depth and clinical attachment level (CAL) were evaluated at three time points baseline, 3rd and 6th month respectively. Additionally the amount of three inflammatory cytokines IL-6, IL-8 and TNF- α in gingival crevicular fluid (GCF) was identified using enzyme linked immune-sorbent assay (ELISA) technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age of ≥ 30 years;\n* ≥ 20 natural teeth; and\n* chronic-periodontitis (≥ 3 mm of CAL and PD pocket depth respectively on at least 30% of dental sites).\n\nExclusion Criteria:\n\n* chronic systemic diseases;\n* PD therapy during last 6 months;\n* habitual use of chewable and non-chewable tobacco (smoking);\n* alcohol consumers; or\n* use of particular medications during last three months (steroidal and non-steroidal drugs/ anti-biotic/ anti-depressants)'}, 'identificationModule': {'nctId': 'NCT04964167', 'briefTitle': 'Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Riyadh Elm University'}, 'officialTitle': 'Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis', 'orgStudyIdInfo': {'id': 'FIRP/2021/94'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group I (Standard Root Planning)', 'interventionNames': ['Combination Product: Plant extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (Standard Root Planning + Photodynamic Therapy)', 'interventionNames': ['Combination Product: Plant extract']}, {'type': 'EXPERIMENTAL', 'label': 'Group III (Standard Root Planning + Aloe Vera)', 'interventionNames': ['Combination Product: Plant extract']}], 'interventions': [{'name': 'Plant extract', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Aloe Vera'], 'description': 'Natural plant extract', 'armGroupLabels': ['Group I (Standard Root Planning)', 'Group II (Standard Root Planning + Photodynamic Therapy)', 'Group III (Standard Root Planning + Aloe Vera)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Liaquat College of Medicine and Dentistry', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Riyadh Elm University', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riyadh Elm University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Salah Abdalkreem Almohana', 'class': 'UNKNOWN'}, {'name': 'Abdulmohsen Khalid Alanazi', 'class': 'UNKNOWN'}, {'name': 'Abdulelah Khalid Alanazi', 'class': 'UNKNOWN'}, {'name': 'Alhanouf Abdulkarem Almohana', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Zeeshan Qamar', 'investigatorAffiliation': 'Riyadh Elm University'}}}}