Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-25 @ 1:49 PM
Study NCT ID:
NCT06805292
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2024-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Acacia Catechu and Low-Level Laser in the Treatmentof Stage II Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-01-30', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inflammatory biomarker', 'timeFrame': '0 and 6 month evaluation', 'description': 'Measuring Interleukin 1 beta level'}, {'measure': 'Antioxidant biomarker', 'timeFrame': '0 and 6 month evaluation', 'description': 'measuring total antioxidant capacity.'}], 'secondaryOutcomes': [{'measure': 'gingival index', 'timeFrame': '0,1,3,6 month evaluation', 'description': 'clinical evaluation of GI\n\nscore from (0 to 3) 0 = normal is the best value. 3 = diseesed (the worst value).\n\n0=Normal gingiva.\n\n1. = mild inflammation, a slight change in color, slight edema, no bleeding on probing.\n2. = moderate inflammation, redness, edema, and glazing; bleeding on probing.\n3. = severe inflammation, marked redness and edema, ulceration, and the tendency to spontaneous bleeding.'}, {'measure': 'clinical attachment level or loss', 'timeFrame': '0,1,3,6 month evaluation', 'description': '* Clinical Attachment Level (CAL) or loss: Clinical attachment level was measured from the cementoenamel junction to the base of the pocket using a University of Michigan probe with the University of North Carolina periodontal probe (UNC15) around each tooth.\n* measurement unite by millimetre\n* zero clinical attachment level means no periodontitis\n* clinical attachment loss is a critical parameter differentiated betwwn gingivitis and periodontitis\n* the less the number, the better the case improvement.\n* cal of 2 mm is better than cal of 4 mm.'}, {'measure': 'plaque index', 'timeFrame': '0,1,3,6 month evaluation', 'description': 'evaluation of PI score from (0-3) 0 is the best value; 3 is the worst.\n\n0=No plaque is visible, even when a probe is used.\n\n1. = Some plaque is visible only when a probe is used to skim the tooth surface.\n2. = A visible amount of plaque can be seen without a probe.\n3. = abudant amount of plaque at gingival margin, interdental spaces filled with plaque.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic periodontitis', 'Herbal Medicine', 'Low Level Laser Therapy', 'Adjunctive therapy', 'Acacia catechu'], 'conditions': ['Chronic Periodontitis']}, 'descriptionModule': {'briefSummary': 'Evaluation of Acacia catechu and Low-Level Laser in the Treatment of Stage 2 Periodontitis.', 'detailedDescription': '* Assess the effectiveness of A. catechu gel (local delivery) adjunctive to non surgical therapy in the treatment of stage chronic periodontitis. Clinical and biochemical evaluation.\n* Compare the effectiveness of A. catechu gel (local delivery) and low-level laser adjunctive to non-surgical therapy in the treatment of stage chronic periodontitis.\n\nClinical and biochemical evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Motivated patient with good oral hygiene.\n2. Age ranges from (30-50) years.\n3. Free from any systemic disease according to the Cornell Medical Index (16).\n\nExclusion Criteria:\n\n1. Patients who received periodontal treatment over the 12 months preceding the study.\n2. Patients who consumed antibiotics or anti-inflammatory drugs within the last 3 months.\n3. Previous or current radiation or immunosuppressive therapies.\n4. Pregnant \\& lactating women.\n5. Patient with orthodontic appliances. Or having partial dentures.\n6. Patient with parafunctional habits.'}, 'identificationModule': {'nctId': 'NCT06805292', 'acronym': 'LLLvsAgel', 'briefTitle': 'Evaluation of Acacia Catechu and Low-Level Laser in the Treatmentof Stage II Periodontitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty of Dental Medicine for Girls'}, 'officialTitle': 'Evaluation of Acacia Catechu and Low-Level Laser in the Treatment of Stage II Periodontitis', 'orgStudyIdInfo': {'id': 'OMPDR-108-1J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Groupe', 'description': 'treated with non-surgical periodontal therapy and serves as a control group.', 'interventionNames': ['Other: phase 1 therapy chronic periodontitis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test: Acacia gel group', 'description': 'using A. catechu gel adjunctive to non-surgical periodontal therapy', 'interventionNames': ['Other: Acacia catechu']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test: laser group', 'description': 'Group III: using low-level laser adjunctive to non-surgical periodontal therapy.', 'interventionNames': ['Other: Low Level Laser Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Test: Acacia gel +laser group', 'description': 'Group IV: using A. catechu gel with low-level laser adjunctive to non-surgical periodontal therapy.', 'interventionNames': ['Other: Acacia catechu', 'Other: Low Level Laser Therapy', 'Other: phase 1 therapy chronic periodontitis', 'Other: local drug delivary acacia +LLL']}], 'interventions': [{'name': 'Acacia catechu', 'type': 'OTHER', 'otherNames': ['acaia catech gel', 'black catechu (trade name )', 'black cutch', 'cutch tree,', 'gel of aqueous extract of A.catechu bark'], 'description': 'local delivery of acacia catechu gel in patient with chronic periodontitis stage 2', 'armGroupLabels': ['Test: Acacia gel +laser group', 'Test: Acacia gel group']}, {'name': 'Low Level Laser Therapy', 'type': 'OTHER', 'otherNames': ['Biomodulation'], 'description': 'low-level laser as an adjunctive therapy in patient with chronic periodontitis stage 2', 'armGroupLabels': ['Test: Acacia gel +laser group', 'Test: laser group']}, {'name': 'phase 1 therapy chronic periodontitis', 'type': 'OTHER', 'otherNames': ['phase 1 therapy (scalling +root planning)'], 'description': 'patient with chronic periodontitis stage 2 will go for phase one therapy only', 'armGroupLabels': ['Control Groupe', 'Test: Acacia gel +laser group']}, {'name': 'local drug delivary acacia +LLL', 'type': 'OTHER', 'otherNames': ['LLL +acacia catehu gel'], 'description': 'pateient with chronic periodontitis treated with LLL +acacia catehu gel', 'armGroupLabels': ['Test: Acacia gel +laser group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Mona Mansour', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'Mona Mansour', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Abeer Gawish, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Al-Azhar University'}, {'name': 'mostafa hegazy, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Al-Azhar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Dental Medicine for Girls', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's degree student at Oral Medicine, Periodontology, Oral Diagnosis, and Oral Radiology Department, Faculty of Dental Medicine for Girls, Al-Azhar University., Principal Investigator).", 'investigatorFullName': 'Mona Monsour', 'investigatorAffiliation': 'Faculty of Dental Medicine for Girls'}}}}