Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT05149651
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2018-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Totalfill® and ProRoot MTA® as Pulpotomy Agent in Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The included teeth were assigned randomly into two groups (Totalfill or MTA) using randomized sequences generated by the computer using Random Integer Generator (RANDOM.ORG, Randomness and Integrity Services Ltd.). The allocation ratio to the groups was set to be equal.\n\nTo ensure double blinding at both patients and evaluators level during treatment, the type of material was concealed from the patient, and the patient had no information which material was used. In addition, the type of material was not mentioned in the patient file. Instead, it was replaced by a 4 digit code. The operators were also blinded for the type of material during the whole procedure starting from tooth preparation till the hemostasis was achieved and then were only informed at the time of material placement.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2018-05-11', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical evaluation', 'timeFrame': '6 months follow-up', 'description': 'Success or failure of the pulpotomy treated teeth is scored based on the Clinical scoring criteria adapted from Zurn \\& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.'}, {'measure': 'Clinical evaluation', 'timeFrame': '12 months follow-up', 'description': 'Success or failure of the pulpotomy treated teeth is scored based on the Clinical scoring criteria adapted from Zurn \\& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.'}, {'measure': 'Radiographic evaluation', 'timeFrame': '6 months follow-up', 'description': 'Success or failure of the pulpotomy treated teeth is scored based on the Radiographic scoring criteria adapted from Zurn \\& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.'}, {'measure': 'Radiographic evaluation', 'timeFrame': '12 months follow-up', 'description': 'Success or failure of the pulpotomy treated teeth is scored based on the Radiographic scoring criteria adapted from Zurn \\& Seale (2008). Score 1 and 2 was estimated as success, while 3 and 4 was estimated as failure.'}], 'secondaryOutcomes': [{'measure': 'Time needed to place the material', 'timeFrame': 'Immediately after each intervention for a maximum of the intervention', 'description': 'To measure the time consumed to place each material and then to compare them if there is a significant difference. After removing the coronal pulp and achieving the hemostasis . The operator start the timer when he places the material till restoring the tooth with GIC.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Totalfill', 'MTA', 'Bioactive', 'calcium silicate cement', 'Pulpotomy', 'Primary molars', 'Bioceramics'], 'conditions': ['Extensively Decayed Primary Molars']}, 'descriptionModule': {'briefSummary': 'An experimental prospective double-blind, randomized clinical trial (RCT) with parallel design. To evaluate the outcome of using 2 pulpotomy agents: Totalfill® as study group and mineral trioxide aggregate (MTA®) as a control.', 'detailedDescription': 'When a tooth decay is too deep and extended into the tooth pulp, then the tooth is not indicated to be treated with a filling. Therefore, removing the diseased pulp and then cover the rest with a suitable material is required. The Purpose of this study is to check the success of pulp treatment on deciduous molars with deep caries using 2 pulp treatment agents: (Totalfill® and MTA®). The use between the materials is randomly assigned. However, the use of the materials has no side effect or complications as it is a routine dental procedure.\n\nThe participants are healthy children aged between 3 and 9 years old, and the study is taking place in Ghent University Hospital, Ghent, Belgium, and it is planned to be conducted in duration of 4 years, which include 20 months for participants recruitment.\n\nAfter placing the material, the tooth is restored with stainless steel crowns, and the participant was asked for follow up to check the tooth and to take dental x-ray every 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient inclusion criteria\n\n * ASA 1 patient, Patient is a completely healthy \\& fit. No allergy or medical conditions.\n * Patient is indicated for treatment under General Anesthesia: young age, uncooperative and extensive treatment plan.\n * Parent agreed to participate in the study, and signed the written consent.\n * Patient attended the out-patients pediatric dental clinic in UZ Gent.\n2. Tooth inclusion criteria 2.1. Clinical inclusion criteria:\n\n * Vital primary molars (first or second) with deep caries cavity with pulpal exposure.\n * Only mandibular primary molar were included\n * No spontaneous pain\n * No history of swelling\n * No sinus tract/ fistula\n * Absent of tenderness in percussion\n * No pathological mobility\n * Restorable tooth (stainless steel crown can be placed)\n * Hemostasis can be achieved with a dry cotton pellet after removal of Coronal pulp.\n\n2.2. Radiographical inclusion criteria:\n\n* At least 2/3rd of root is present\n* Absence of internal or external root resorption\n* Absence of pathologic root resorption\n* Absence of periapical or furcation radiolucency\n\nExclusion Criteria:\n\nIf one or more of the criteria mentioned above is not fulfilled, the teeth were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT05149651', 'briefTitle': 'Efficacy of Totalfill® and ProRoot MTA® as Pulpotomy Agent in Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Clinical and Radiographic Outcomes of Pulpotomy of Primary Molars Using Totalfill® Bioceramic Root Repair Material -Fast Set Putty, and ProRoot White MTA®. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EC UZG 2016/0723 - 2016/0724'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Totalfill', 'description': 'Totalfill® Bioceramic Root Repair Material -Fast Set Putty used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy', 'interventionNames': ['Drug: Totalfill']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MTA', 'description': 'ProRoot White MTA® used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy', 'interventionNames': ['Drug: MTA']}], 'interventions': [{'name': 'Totalfill', 'type': 'DRUG', 'otherNames': ['Totalfill® Bioceramic Root Repair Material -Fast Set Putty'], 'description': 'Totalfill® Bioceramic Root Repair Material -Fast Set Putty is a pre-mixed, bioactive calcium silicate cement which used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy.', 'armGroupLabels': ['Totalfill']}, {'name': 'MTA', 'type': 'DRUG', 'otherNames': ['ProRoot White MTA®'], 'description': 'ProRoot White MTA® is a bioactive calcium silicate cement which used as pulpotomy agent to treat extensive decayed tooth indicated for pulpotomy.', 'armGroupLabels': ['MTA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'After publication', 'ipdSharing': 'YES', 'description': 'The data will be available in the literature in the manuscript after publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}