Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-10 @ 7:33 AM
Study NCT ID:
NCT07184268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of NST With Local Delivery of Ozonated Olive Versus Curcumin Gel in Stage II Grade B 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The test group "Group 1" will receive full Scaling and root planing (SRP) followed by subgingival application of ozonated olive gel.\n\nThe control group "Group 2" will receive full-mouth SRP followed by subgingival application of curcumin gel'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-14', 'studyFirstSubmitDate': '2025-09-08', 'studyFirstSubmitQcDate': '2025-09-14', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical attachment level', 'timeFrame': '3 months', 'description': 'measured from the cementoenamel junction (CEJ) to the bottom of pocket.'}], 'secondaryOutcomes': [{'measure': 'Gingival Index', 'timeFrame': '3 months', 'description': 'Index scores will be recorded showing gingival bleeding and inflammation'}, {'measure': 'Plaque index', 'timeFrame': '3 months', 'description': 'be used to evaluate plaque accumulation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nonsurgical therapy', 'local delivery gel', 'curcumin gel', 'ozonated olive oil', 'molar incisor pattern periodontitis', 'Chronic periodontitis', 'stage II grade B'], 'conditions': ['Periodontitis, Adult']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to evaluate the effectiveness of local delivery ozonated olive gel versus curcumin gel as adjunct to scaling and root planing in the treatment of stage II grade B periodontitis in on both males and females in the age group between 18 and 50 years. outcome measures are Clinical attachment level (CAL), plaque index (PI), gingival index (GI).', 'detailedDescription': "Periodontitis is an advanced periodontal disease with a distinctive clinical signs and symptoms as rapid attachment loss and bone destruction\n\nThe primary treatment approach for periodontitis is mechanical plaque removal through debridement, particularly scaling and root planing (SRP) using hand or ultrasonic instruments.\n\ncurcumin gel is an adjunct to non-surgical periodontal therapy is a highly potent local antioxidant and anti-inflammatory agent. While ozone has a potent antimicrobial and anti-inflammatory effects it also can be incorporated into a lipid carrier such as olive oil. Ozone's stability and ease of application are markedly enhanced. Ozonized olive oil can be formulated into a gel with ideal rheological properties for injection into periodontal pockets."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with stage II periodontitis defined by having interdental CAL 3-4 mm and presence of pocket depth (PD) ≤ 5 mm, and grade B periodontitis characterized by a moderate rate of disease progression.\n2. Patients agree to a 3-month follow-up period and provide an informed consent.\n\nExclusion Criteria:\n\n1. Presence of prosthetic crowns, overhanging restorations and orthodontic treatment.\n2. Teeth with both endo-perio lesions.\n3. Antibiotics therapy that has an impact on the clinical signs and symptoms of periodontitis in the previous 3 months.\n4. Anti-inflammatory drugs in the previous 1 month.\n\n6\\. History of systemic disease, allergy, cardiovascular diseases, diabetes mellitus, hypertension, bleeding disorders, hyperparathyroidism, and compromised medical conditions, pregnant and lactating females.'}, 'identificationModule': {'nctId': 'NCT07184268', 'briefTitle': 'Clinical Efficacy of NST With Local Delivery of Ozonated Olive Versus Curcumin Gel in Stage II Grade B Periodontitis.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Efficacy of Non-surgical Therapy With Local Delivery of Ozonated Olive Oil Gel Versus Curcumin Gel in Stage II Grade B Periodontitis Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': '892025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'curcumin gel', 'description': 'The curcumin gel will be gently deposited into the periodontal pockets to ensure adequate subgingival delivery.', 'interventionNames': ['Procedure: full mouth non-surgical scaling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ozonated olive gel.', 'description': 'patients will receive subgingival application of ozonated olive oil in the periodontal pocket', 'interventionNames': ['Procedure: full mouth non-surgical scaling']}], 'interventions': [{'name': 'full mouth non-surgical scaling', 'type': 'PROCEDURE', 'description': 'All patients will receive a full mouth scaling using ultrasonic scalers and hand instrumentation', 'armGroupLabels': ['curcumin gel', 'ozonated olive gel.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Parryhan M Abdelsamie, PhD', 'role': 'CONTACT', 'email': 'Parryhan.abdelsamie@dentistry.cu.edu.eg', 'phone': '01003082353'}, {'name': 'Parryhan M Abdelsamie, PhD', 'role': 'CONTACT', 'email': 'Parryhan.abdelsamie@live.com', 'phone': '01153938582'}], 'overallOfficials': [{'name': 'Parryhan M Abdelsamie', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MTI University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'MTI University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of periodontology', 'investigatorFullName': 'Parryhan Mohamed Abdelsamie', 'investigatorAffiliation': 'Cairo University'}}}}