Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-04 @ 10:22 AM
Study NCT ID:
NCT06597669
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure of stainless steel crowns', 'timeFrame': '3 months', 'description': 'Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.'}, {'measure': 'Failure of stainless steel crowns', 'timeFrame': '6 months', 'description': 'Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.'}, {'measure': 'Failure of stainless steel crowns', 'timeFrame': '9 months', 'description': 'Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.'}, {'measure': 'Failure of stainless steel crowns', 'timeFrame': '12 months', 'description': 'Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.'}], 'secondaryOutcomes': [{'measure': 'Occlusal contact', 'timeFrame': '0 months', 'description': 'Occlusal contact was assessed as follows: normal occlusion or rised occlusion.'}, {'measure': 'Occlusal contact', 'timeFrame': '3 months', 'description': 'Occlusal contact was assessed as follows: normal occlusion or rised occlusion.'}, {'measure': 'Occlusal contact', 'timeFrame': '6 months', 'description': 'Occlusal contact was assessed as follows: normal occlusion or rised occlusion.'}, {'measure': 'Occlusal contact', 'timeFrame': '9 months', 'description': 'Occlusal contact was assessed as follows: normal occlusion or rised occlusion.'}, {'measure': 'Occlusal contact', 'timeFrame': '12 months', 'description': 'Occlusal contact was assessed as follows: normal occlusion or rised occlusion.'}, {'measure': 'Periodontal health', 'timeFrame': '0 months', 'description': '* Plaque index 0 = No plaque in the gingival area.\n\n 1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.\n 2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.\n 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.\n* Gingival index 0 = Normal gingiva\n\n 1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing\n 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing\n 3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.'}, {'measure': 'Periodontal health', 'timeFrame': '3 months', 'description': '* Plaque index 0 = No plaque in the gingival area.\n\n 1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.\n 2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.\n 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.\n* Gingival index 0 = Normal gingiva\n\n 1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing\n 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing\n 3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.'}, {'measure': 'Periodontal health', 'timeFrame': '6 months', 'description': '* Plaque index 0 = No plaque in the gingival area.\n\n 1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.\n 2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.\n 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.\n* Gingival index 0 = Normal gingiva\n\n 1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing\n 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing\n 3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.'}, {'measure': 'Periodontal health', 'timeFrame': '9 months', 'description': '* Plaque index 0 = No plaque in the gingival area.\n\n 1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.\n 2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.\n 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.\n* Gingival index 0 = Normal gingiva\n\n 1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing\n 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing\n 3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.'}, {'measure': 'Periodontal health', 'timeFrame': '12 months', 'description': '* Plaque index 0 = No plaque in the gingival area.\n\n 1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.\n 2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.\n 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.\n* Gingival index 0 = Normal gingiva\n\n 1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing\n 2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing\n 3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental caries', 'Primary molars', 'Stainless steel crowns'], 'conditions': ['Caries,Dental']}, 'descriptionModule': {'briefSummary': 'Stainless steel crowns have shown high success in restoring carious primary molars over a longer period of time than conventional restorations. This study aims to evaluate the treatment effectiveness of conventional SSCs restoration and Hall technique in treating carious primary molars'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Agree and voluntarily participate in the research (with the patient's parent/guardian consent for participation)\n2. Children have a primary molar with at least 2 carious lesions corresponding to International Caries Detection and Assessment System (ICDAS) scores 4 or at least 1 carious lesion corresponding to ICDAS scores 5 and 6.\n\nExclusion Criteria:\n\n1. Children with systemic diseases such as immunodeficiency, cardiovascular disease, or bleeding disorders.\n2. Children are allergic to nickel and resin.\n3. Children unable to return for recall visits.\n4. Primary molar has signs of pulpal/periapical diseases (irreversible pulpitis, pulp necrosis, loosening, fistula, or abscess).\n5. Children are undergoing orthodontic treatment with fixed or removable appliances."}, 'identificationModule': {'nctId': 'NCT06597669', 'briefTitle': 'Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Hue University of Medicine and Pharmacy'}, 'officialTitle': 'Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars', 'orgStudyIdInfo': {'id': 'H2024/097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional Technique', 'description': 'A stainless steel crown will place on a carious primary molar after preparation', 'interventionNames': ['Procedure: Placement of stainless steel crowns on primary molars']}, {'type': 'EXPERIMENTAL', 'label': 'Hall technique', 'description': 'A stainless steel crown will place on a carious primary molar without local anesthesia caries removal or any preparation', 'interventionNames': ['Procedure: Placement of stainless steel crowns on primary molars']}], 'interventions': [{'name': 'Placement of stainless steel crowns on primary molars', 'type': 'PROCEDURE', 'description': 'Preformed metal crowns have been placed to treat caries in primary molars', 'armGroupLabels': ['Conventional Technique', 'Hall technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49120', 'city': 'Huế', 'state': 'Thừa Thiên Huế Province', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Thanh Thao Nguyen, MD, PhD', 'role': 'CONTACT', 'email': 'stir@huemed-univ.edu.vn', 'phone': '+84234 3822 173'}, {'name': 'Van Nhat Thang Le, DDS, PhD', 'role': 'CONTACT'}], 'facility': 'Hue University of Medicine and Pharmacy', 'geoPoint': {'lat': 16.4619, 'lon': 107.59546}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'Will plan to share information when finishing study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hue University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Le Van Nhat Thang', 'investigatorAffiliation': 'Hue University of Medicine and Pharmacy'}}}}