Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-01-02 @ 12:03 AM
Study NCT ID:
NCT04770792
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2021-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C010882', 'term': 'chlorhexidine gluconate'}, {'id': 'C086631', 'term': 'mineral trioxide aggregate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-24', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Data Recording Sheet for Intraoral Clinical Examination', 'timeFrame': '12 months', 'description': 'Data sheet for recording the clinical outcome criteria obtained by intraoral clinical examination is filled by the investigators. The data sheet includes information regarding the presence or absence of the following:\n\n1. Spontaneous pain.\n2. Pain on percussion.\n3. Signs of abscess or fistula.\n4. Abnormal mobility. The response for each point is interpreted in the form by either "yes" or "no".'}, {'measure': 'Data Recording Sheet for Periapical Radiographic Evaluation', 'timeFrame': '12 months', 'description': 'Data sheet for recording the radiographic outcome criteria obtained from periapical radiograph is filled by the investigators. The data sheet includes information regarding the presence or absence of the following:\n\n1. Radiolucency at the periapical or interradicular areas.\n2. Loss of lamina dura.\n3. Signs of internal root resorption.\n4. Signs of external pathologic root resorption.\n5. Normal root resorption accompanying the exfoliation process. The response for each point is interpreted in the form by either "yes" or "no".'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Indirect pulp treatment', 'Deep caries', 'Primary molars', 'Mineral trioxide aggregate', '2% chlorhexidine gluconate'], 'conditions': ['Indirect Pulp Treatment']}, 'descriptionModule': {'briefSummary': "The aim of this study was to compare the clinical and radiographic success rates of indirect pulp treatment (IPT) performed by combining 2% chlorhexidine gluconate with mineral trioxide aggregate (MTA) versus IPT performed with MTA in children's vital primary molars. A randomized, split-mouth design including 40 children aged 4-8 years was implemented. The study sample composed of 80 primary molars with deep carious lesions. Each child had 1 pair, one tooth from each pair was allocated randomly either to the 2% chlorhexidine gluconate/MTA group or the MTA group. All teeth were restored with stainless steel crowns. Follow-up is carried out to evaluate the teeth clinically and radiographically.", 'detailedDescription': 'A double blinded, randomized, controlled clinical trial was performed in a split-mouth design. Eighty primary molars in forty subjects were randomly allocated that each subject had one tooth treated with 2% chlorhexidine gluconate and MTA (experimental group), and the other tooth treated with only MTA (control group).\n\nThe study was held at King Abdulaziz University Dental Hospital (KAUDH), Jeddah. Forty healthy children with the age range 4- to 8-year-old were included. Each patient had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.\n\nPreoperative periapical radiographs of the teeth considered for treatment in the study were made using extension cone paralleling technique in the x ray machine.\n\nThe procedure was performed in two visits by one operator to allow for the setting of MTA. Stainless steel crowns were used as final restorations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient inclusion criteria:\n\n* 4-8 years old.\n* Healthy.\n* Cooperative.\n* Had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT.\n\nTeeth inclusion criteria:\n\n* No spontaneous pain.\n* No pain on palpation or percussion.\n* No signs of fistula or abscess.\n* No abnormal mobility.\n* No radiolucency at the periapical or interradicular areas.\n* No loss of lamina dura.\n* No radiographic signs of internal resorption.\n* Sufficient tooth structure allowing placement of rubber dam.\n* Not expected to exfoliate within 1 year.\n\nExclusion Criteria:\n\n* Spontaneous pain.\n* Pain on palpation or percussion.\n* Signs of fistula or abscess.\n* Presence of abnormal mobility.\n* Radiolucency at the periapical or interradicular areas.\n* Loss of lamina dura.\n* Radiographic signs of internal resorption.\n* No sufficient tooth structure allowing placement of rubber dam.\n* Expected to exfoliate within 1 year.'}, 'identificationModule': {'nctId': 'NCT04770792', 'briefTitle': 'The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'King Abdulaziz University'}, 'officialTitle': 'The Use of 2% Chlorhexidine Gluconate With Mineral Trioxide Aggregate in Indirect Pulp Treatment of Primary Molars: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'ASaber'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': '2% chlorhexidine gluconate with mineral trioxide aggregate.', 'interventionNames': ['Other: 2% chlorhexidine gluconate with mineral trioxide aggregate.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Mineral trioxide aggregate.', 'interventionNames': ['Other: Mineral trioxide aggregate.']}], 'interventions': [{'name': '2% chlorhexidine gluconate with mineral trioxide aggregate.', 'type': 'OTHER', 'description': '2% chlorhexidine gluconate with mineral trioxide aggregate.', 'armGroupLabels': ['Experimental group']}, {'name': 'Mineral trioxide aggregate.', 'type': 'OTHER', 'description': 'Mineral trioxide aggregate.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Jeddah 21589', 'city': 'Jeddah', 'state': 'Mecca Region', 'country': 'Saudi Arabia', 'facility': 'King Abdulaziz University', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'Afnan M Saber, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Phd student at Pediatric Dentistry Department, Faculty of Dentistry, King Abdulaziz University.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Afnan Saber', 'investigatorAffiliation': 'King Abdulaziz University'}}}}