Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-01 @ 7:55 PM
Study NCT ID:
NCT05496257
Status:
UNKNOWN
Last Update Posted:
2022-08-11
First Post:
2022-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2022-08-05', 'studyFirstSubmitQcDate': '2022-08-08', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical findings', 'timeFrame': '2 year follow up', 'description': 'The children will be recalled for postoperative clinical \\& radiographic assessments at the following intervals; six, twelve, eighteen,and twenty-four months.the treatment will be considered successful if none of the following clinical or radiographic findings is present:\n\nClinical criteria:\n\n1. Pain.\n2. Tenderness to palpation or percussion\n3. Gingival swelling or sinus tract.\n4. Purulent exudate expressed from the gingival margin.\n5. Abnormal tooth mobility.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Direct Pulp Capping']}, 'descriptionModule': {'briefSummary': 'The trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars.', 'detailedDescription': 'The current equivalent parallel randomized controlled trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars over a 24-month follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Clinical:\n\n 1. Children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.\n 2. Children rated as no. 3 or 4 in Frankl behaviour rating scale (FBRS).\n 3. Presence of a small carious or traumatic pulp exposure (1 mm or less). 2. Radiographic:\n\n <!-- -->\n\n 1. Presence of at least two-thirds of root length.\n 2. Normal lamina dura and periodontal ligament space.\n\nExclusion Criteria:\n\n* 1\\. Clinical:\n\n 1. History of spontaneous unprovoked toothache.\n 2. Extensive crown destruction that preclude coronal restoration.\n 3. Gingival swelling, sinus tract or other soft tissue pathology.\n 4. Abnormal tooth mobility.\n 5. A frank pulp exposure (i.e., greater than 1.0mm), requiring pulpotomy.\n 6. No evidence of visible pulp exposure.\n\n 2\\. Radiographic:\n\n <!-- -->\n\n 1. Furcation/periapical radiolucency.\n 2. Pathological internal/external root resorption.\n 3. Absence of underlying permanent successor'}, 'identificationModule': {'nctId': 'NCT05496257', 'briefTitle': 'Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars: An Equivalent Parallel Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '524_1/11/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I (control): Calcium hydroxide cement', 'description': 'Pulp capping material', 'interventionNames': ['Other: direct pulp capping in primary molars']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Premixed bioceramic putty', 'description': 'Pulp capping material', 'interventionNames': ['Other: direct pulp capping in primary molars']}], 'interventions': [{'name': 'direct pulp capping in primary molars', 'type': 'OTHER', 'description': 'caries will be removed, and if the pulps are exposed, the material will be place directly over the exposed pulp.', 'armGroupLabels': ['Group 2: Premixed bioceramic putty', 'Group I (control): Calcium hydroxide cement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minya', 'country': 'Egypt', 'facility': 'Minia university', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident in Pediatric and Community Dentistry Department, Faculty of Dentistry, Assuit University', 'investigatorFullName': 'Merrette Basem Khalaf Sedhom', 'investigatorAffiliation': 'Assiut University'}}}}