Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-01-01 @ 10:55 AM
Study NCT ID:
NCT04032132
Status:
COMPLETED
Last Update Posted:
2019-07-25
First Post:
2019-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Curcumin Paste as an Adjunctive Therapy in 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': 'D003475', 'term': 'Curettage'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2019-07-19', 'studyFirstSubmitQcDate': '2019-07-23', 'lastUpdatePostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical score', 'timeFrame': 'change from base line at 6 months', 'description': 'Evaluate the influence of curcumin paste on the clinical outcomes of the surgical treatment.to see if curcumin has a positive effect in reduction oh deep periodontal pockets and leads to greater bone gain'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['curcumin', 'CBCT', 'HPLC', 'periodontitis'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The turmeric (Curcuma longa) plant, a herb belonging to the ginger family. The most active component of turmeric is curcumin, which makes up 2 to 5% of the spice. Curcumin showed has antibacterial effect against periodontal pathogen and positive result regarding conventional treatment of periodontal disease due to its anti-inflammatory, anti-oxidant and wound healing properties. This study will be carried out to examine the effect of curcumin when used in conjunction with open flap debridement treating deep periodontal pockets. (suggesting that it may have positive effect)', 'detailedDescription': 'The present study entailed twenty four patients having stage II or stage III, Grade A periodontitis with 24 intrabony defects. Patients were divided into two groups; group I was subjected to open flap debridement only. Group II was subjected to curcumin paste (2%curcumin)in conjunction with open flap debridement Clinical parameters including plaque index, sulcus bleeding index, probing depth and clinical attachment level were recorded pre-surgical. Moreover, radiographic examination was performed by cone beam computed tomography (CBCT) just before the surgery . Vertical bone defects were exposed by full thickness mucoperiosteal flap following intrasulcular incision and thorough debridement was performed. Group II received local application of curcumin paste.The same initial clinical parameters were recorded three and six months postoperatively. Radiographic measurements were recorded six months post surgically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female with age range 25-45 years.\n2. At least a single posterior 2-3 wall periodontal defect of pocket depth ≥ 5mm; clinical attachment level ≥ 3 mm, Intrabony component ≥ 3 mm and with plaque index ≤1 (Löe 1967) and bleeding index ≤1 (Mühlemann \\& Son 1971). All the previous criteria were determined 2 weeks after phase I conventional periodontal therapy.\n3. Systemically Healthy as evidenced by Burket's oral medicine health history questionnaire (Glick et al., 2008).\n\nExclusion Criteria:\n\n* 1- Smokers. 2- Pregnant. 3- Patient unwilling to comply to periodontaloral hygienic instructions. 4- Vulnerable groups. (e.g: Decisionally impaired individual)"}, 'identificationModule': {'nctId': 'NCT04032132', 'briefTitle': 'Curcumin Paste as an Adjunctive Therapy in Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Local Application of Curcumin in Conjunction With the Surgical Treatment of Intrabony Periodontal Defects "Controlled Clinical Study With Evaluation of Curcumin Release Profile"', 'orgStudyIdInfo': {'id': 'FER16 20-M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'curcumin paste in conjunction with open flap debridement surge', 'description': 'curcumin paste (2% circumin) in conjunction with open flap debridement surgery', 'interventionNames': ['Drug: curcumin paste', 'Procedure: curettage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'open flap debridement surgery only', 'description': 'surgical treatment for periodontal pocket', 'interventionNames': ['Procedure: curettage']}], 'interventions': [{'name': 'curcumin paste', 'type': 'DRUG', 'description': 'curcumin is a herb used for medical purpose', 'armGroupLabels': ['curcumin paste in conjunction with open flap debridement surge']}, {'name': 'curettage', 'type': 'PROCEDURE', 'description': 'open flab debridement surgery', 'armGroupLabels': ['curcumin paste in conjunction with open flap debridement surge', 'open flap debridement surgery only']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ahmed Y Gamal, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of dentistry -Ain Shams university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Administrator of oral medicine and periodontology', 'investigatorFullName': 'Yasmine Gamal', 'investigatorAffiliation': 'Ain Shams University'}}}}