Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT06016933
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2023-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Spirulina on 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2023-08-24', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical attachment level', 'timeFrame': '3 months', 'description': 'Clinical attachment level was measured at baseline, 1 and 3 months after gel application.'}, {'measure': 'Probing pocket depth', 'timeFrame': '3 months', 'description': 'Probing pocket depth was measured at baseline, 1 and 3 months after gel application.'}, {'measure': 'Interleukin 6.', 'timeFrame': '3 months', 'description': 'Enzyme linked immune-assay for the quantitative measurement of interleukin 6 concentration in gingival cervicular fluid at baseline, 1 and 3 months after gel application.'}], 'secondaryOutcomes': [{'measure': 'Plaque Index', 'timeFrame': '3 months', 'description': 'Plaque index was measured at baseline and at 1, and 3-months post treatment.'}, {'measure': 'Gingival index', 'timeFrame': '3 months', 'description': 'Gingival index was measured at baseline and at 1, and 3-months post treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the clinical and immunological effect of spirulina in treatment of stage II periodontitis.', 'detailedDescription': 'In this study, the investigators tested the effect of spirulina gel as adjunctive of scaling and root planing in treatment of stage II, grade B periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and level of interleukin 6.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the patients suffer from stage II, grade B periodonitis with attachment loss 3-4 mm and probing pocket depth ≤ 5mm.\n\nExclusion Criteria:\n\n* Any systemic disease that affects the periodontium. ·\n* Pregnant, postmenopausal women. ·\n* People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 3 month.\n* People who use mouth washes regularly ·\n* Participation in other clinical trials.'}, 'identificationModule': {'nctId': 'NCT06016933', 'briefTitle': 'Effect of Spirulina on Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Effect of Locally Delivered Spirulina Gel on Treatment of Stage II, Grade B Periodontitis', 'orgStudyIdInfo': {'id': '5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'oral hygiene instructions and SRP of all teeth plus placebo gel.', 'interventionNames': ['Procedure: SRP of all teeth']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.', 'interventionNames': ['Drug: spirulina gel', 'Procedure: SRP of all teeth']}], 'interventions': [{'name': 'spirulina gel', 'type': 'DRUG', 'description': 'Patient were received spirulina gel in diseased sites. The process will be repeated at 7, 14, 21 days.', 'armGroupLabels': ['oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.']}, {'name': 'SRP of all teeth', 'type': 'PROCEDURE', 'description': 'Patients received oral hygiene instructions and SRP of all teeth.', 'armGroupLabels': ['oral hygiene instructions and SRP of all teeth plus placebo gel.', 'oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Kafrelsheikh University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. of Oral Medicine and Periodontology', 'investigatorFullName': 'Enas Elgendy', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}