Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-29 @ 3:33 PM
Study NCT ID:
NCT02943759
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2016-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resolution of Pain and Swelling After the Use of Neem Leaf Extract Compared to Chlorhexidine Gluconate as an Intracanal Irrigant During Pulpectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010482', 'term': 'Periapical Abscess'}], 'ancestors': [{'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010485', 'term': 'Periapical Periodontitis'}, {'id': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010882', 'term': 'chlorhexidine gluconate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2016-10-21', 'studyFirstSubmitQcDate': '2016-10-24', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '1 year', 'description': 'Patient reported pain and pain on percussion , binary'}, {'measure': 'Swelling', 'timeFrame': '1 year', 'description': 'Visual examination ,binary'}, {'measure': 'Mobility', 'timeFrame': '1 year', 'description': 'Mobility test ,binary'}], 'secondaryOutcomes': [{'measure': 'Bacterial load', 'timeFrame': '48 hours', 'description': 'Bacteria on culture plates measuring unit CFU/ml'}, {'measure': 'Periapical pathosis', 'timeFrame': '1 year', 'description': 'Periapical radiograph , binary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periapical Abscess']}, 'referencesModule': {'references': [{'pmid': '24778508', 'type': 'BACKGROUND', 'citation': 'Dutta A, Kundabala M. Comparative anti-microbial efficacy of Azadirachta indica irrigant with standard endodontic irrigants: A preliminary study. J Conserv Dent. 2014 Mar;17(2):133-7. doi: 10.4103/0972-0707.128047.'}, {'pmid': '14977302', 'type': 'BACKGROUND', 'citation': 'Ercan E, Ozekinci T, Atakul F, Gul K. Antibacterial activity of 2% chlorhexidine gluconate and 5.25% sodium hypochlorite in infected root canal: in vivo study. J Endod. 2004 Feb;30(2):84-7. doi: 10.1097/00004770-200402000-00005.'}, {'pmid': '23265154', 'type': 'BACKGROUND', 'citation': 'Louwakul P, Prucksathamrongkul W. The effect of 2% chlorhexidine as root canal irrigant in pulpectomies of primary molars. Pediatr Dent. 2012 Nov-Dec;34(7):e192-6.'}, {'pmid': '26929692', 'type': 'BACKGROUND', 'citation': 'Podar R, Kulkarni GP, Dadu SS, Singh S, Singh SH. In vivo antimicrobial efficacy of 6% Morinda citrifolia, Azadirachta indica, and 3% sodium hypochlorite as root canal irrigants. Eur J Dent. 2015 Oct-Dec;9(4):529-534. doi: 10.4103/1305-7456.172615.'}, {'pmid': '21678668', 'type': 'BACKGROUND', 'citation': 'Ruiz-Esparza CL, Garrocho-Rangel A, Gonzalez-Amaro AM, Flores-Reyes H, Pozos-Guillen AJ. Reduction in bacterial loading using 2% chlorhexidine gluconate as an irrigant in pulpectomized primary teeth: a preliminary report. J Clin Pediatr Dent. 2011 Spring;35(3):265-70. doi: 10.17796/jcpd.35.3.y052311j23617837.'}]}, 'descriptionModule': {'briefSummary': 'The trial is to test the resolution of pain, swelling and other signs of periapical infection and the antimicrobial efficacy when using the neem leaf extract compared to chlorhexidine as root canal irrigant in Pulpectomy treatment for children.', 'detailedDescription': 'To compare the effectiveness of neem leaf extract with that of Chlorhexidine gluconate when used as an intracanal irrigant in primary molar teeth indicated for pulpectomy treatment.\n\nP: children with primary necrotic molars indicated for pulpectomy I: Neem leaf extract (alcoholic solution). C: 2% chlorhexidine gluconate. O: Pain and swelling resolution. T:Over 12 months. S: Randomised controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient and parent cooperation.\n\n * Absence of any systemic disease that would contraindicate pulp therapy.\n * Non vital molar teeth presenting with an acute or chronic periapical infection as a result of pulp necrosis ( Periapical abscess ,a sinus tract formation as a sequelae )\n * Making sure the patient is not taking an antibiotic and has not taken it for the past 2 weeks.\n * Absence of physiologic or pathologic root resorption that contraindicate pulp therapy.\n * Restorable teeth\n * Molars with at least two thirds of root remaining.\n\nExclusion Criteria:\n\n* Children with any condition that contraindicates pulp therapy will be excluded (rheumatic fever, infective endocarditis , leukemia , corticosteroid therapy and immunosuppressed children).'}, 'identificationModule': {'nctId': 'NCT02943759', 'briefTitle': 'Resolution of Pain and Swelling After the Use of Neem Leaf Extract Compared to Chlorhexidine Gluconate as an Intracanal Irrigant During Pulpectomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Resolution of Pain and Swelling After the Use of Neem Leaf Extract (Azadirachta Indica) Compared to Chlorhexidine Gluconate as an Intracanal Irrigant in Necrotic Primary Molar Teeth in Children Undergoing Pulpectomy Treatment: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'Chx_neemleaf'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neem leaf extract', 'description': 'Neem leaf extract (alcoholic solution) used as an anti inflammatory , antibacterial irrigant', 'interventionNames': ['Drug: Neem leaf extract']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine gluconate', 'description': '2% chlorhexidine gluconate intracanal irrigant solution used as an antibacterial chemical mean for canal irrigation', 'interventionNames': ['Drug: Chlorhexidine gluconate']}], 'interventions': [{'name': 'Neem leaf extract', 'type': 'DRUG', 'description': 'A natural irrigant solution act as anti-inflammatory and anti bacterial', 'armGroupLabels': ['Neem leaf extract']}, {'name': 'Chlorhexidine gluconate', 'type': 'DRUG', 'otherNames': ['Gluconate-Chex 2%'], 'description': '2%chlorhexidine gluconate , anti bacterial root canal irrigant solution', 'armGroupLabels': ['Chlorhexidine gluconate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Pediatric dentistry and Public health department-Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Dalia M Moheb, Assoc Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pediatric Dentistry & Dental Public Health Faculty of Oral & Dental Medicine , Cairo university'}, {'name': 'Norhan A El Dokky, Assoc Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pediatric Dentistry & Dental Public Health Faculty of Oral & Dental Medicine , Cairo university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mennatallah Sameh Ahmed Farouk Abdelhamid', 'investigatorAffiliation': 'Cairo University'}}}}