Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 3:04 AM
Study NCT ID:
NCT06924203
Status:
COMPLETED
Last Update Posted:
2025-04-11
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Amalgam and Hall Technique in Treatment of Carious Primary Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013193', 'term': 'Stainless Steel'}], 'ancestors': [{'id': 'D013232', 'term': 'Steel'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000497', 'term': 'Alloys'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Compare between Amalgam and Hall technique in restoration decyaed primary molars by split mouth technique..\n\nacceptability of Hall technique for care givers and children..'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Active Comparator:Amalgam group for decayed primary molars Experimental: Hall technique for restore decayed primary molars split mouth technique.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2025-04-04', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': '12 months', 'description': 'Pain scores were evaluated VAS pain 10-score scale'}, {'measure': 'Swelling', 'timeFrame': '12 months', 'description': 'Swelling scores'}, {'measure': 'Tooth mobility evaluation', 'timeFrame': '12 months', 'description': 'Tooth mobility evaluation; Tooth mobiIity wiII be graded cIinicaIIy by Grace \\& SmaIes mobiIity index.'}, {'measure': 'Restoration efficiency', 'timeFrame': '3 months', 'description': 'Restoration efficiency; Grase \\& SmaIis MobiIity Index Grade 0: 0.25 (physioIogic tooth mobiIity). Grade 1: 1 mm (HorizontaI mobiIity). Grade 2: 2 mm (HorizontaI mobiIity). Grade 3: 2 mm (HorizontaI and verticaI mobiIity).'}, {'measure': 'Gingival index', 'timeFrame': '12 months', 'description': 'The GI uses the following scoring system:\n\n0 = normal gingiva;\n\n1. = mild inflammation: slight change in color, slight edema, no bleeding on probing;\n2. = moderate inflammation: redness, edema, and glazing, or bleeding on probing;\n3. = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding, ulceration.'}, {'measure': 'Radiographic examination', 'timeFrame': '12 months', 'description': 'The radiographs will taken using the Parallel Periapical Technique, will be taken immediately on the first visit post operatively, to act as base line for radiographic evaluation.\n\nThe following criteria of radiographic assessment will include:\n\n1. ExternaI or internaI root resorption.\n2. Inter-radicuIar bone resorption.\n3. Widening of the periodontaI Iigament space.\n4. PeriapicaI radioIucency. The chiIdren will be recaIIed at the foIIowe up periods at , 3, 6, 9 and12 months to evaIuate periapical radiograoh.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caries', 'Hall technique', 'Amalgam', 'Primary molars'], 'conditions': ['Dental Caries in Children']}, 'referencesModule': {'references': [{'pmid': '24683915', 'type': 'BACKGROUND', 'citation': 'Page LA, Boyd DH, Davidson SE, McKay SK, Thomson WM, Innes NP. Acceptability of the Hall Technique to parents and children. N Z Dent J. 2014 Mar;110(1):12-7.'}]}, 'descriptionModule': {'briefSummary': 'compare between amalgam restoration and hall technique for treatment of decayed primary molars and intervention treatment for decayed primary molars in children, age 3-5 years using split mouth technique in the same child, conventional amalgam restoration and use Stainless steel crown in other side', 'detailedDescription': 'This study wiII be conducted on 30 chiIdren: The moIars wiII be treated by spIit mouth technique.\n\n(AmaIgam group): 30 carious moIars, wiII be restored with (amaIgam) code 4 or 5 (16).\n\n( StainIess steeI crowns group): 30 carious moIars wiII be restored with ((HaII Tech).\n\n\\- CIinicaI Assessment:\n\nDuring follow up periods if:\n\n* Pain\n* redness, and\n* sweIIing wiII be assessed for presence or absence(18).\n* Tooth mobiIity wiII be graded cIinicaIIy by Grace \\& SmaIes mobiIity index(19).\n* Restoration effecincy.\n* Gingival index Gingival index (GI)\n\nRadiographic examination ( Parallel PeriapicaI Radiograph) :\n\nThe radiographs will taken using the Parallel Periapical Technique, will be taken immediately on the first visit post operatively, to act as base line for radiographic evaluation.\n\nThe following criteria of radiographic assessment will include:\n\n1. ExternaI or internaI root resorption.\n2. Inter-radicuIar bone resorption.\n3. Widening of the periodontaI Iigament space.\n4. PeriapicaI radioIucency.\n\nThe chiIdren will be recaIIed at the foIIowe up periods at , 3, 6, 9 and12 months to evaIuate periapical radiograoh.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Apparently healthy children aged from 3-5 years old of both sexes.\n2. cooperative children scored (3 or 4) according to Frankle behavior scale.\n3. Informed consent were obtained from parents or care givers.\n4. Children had bilateral carious primary molars were scored code 4 or code 5 according to (I.C.D.A.S.C) international caries restorable and evaluation method (split mouth tech).\n\nExclusion Criteria:\n\n1. Clinical history of spontaneous pain, intra-oral or facial swelling or presence of fistula or sinus tract.\n2. Radiographic findings of root resorption, pulp stone, furcation involvement or periapical pathosis as revealed by preoperative periapical radiography.\n3. Patients who have any history of hypersensitivity to any of the materials to be used.\n4. Parents/children who are uncooperative or refused to participate in the study.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT06924203', 'briefTitle': 'Comparison Between Amalgam and Hall Technique in Treatment of Carious Primary Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Comparison Between Amalgam Restoration and Hall Technique in Treatment of Carious Primary Molars', 'orgStudyIdInfo': {'id': 'REC 185/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Amalgam group', 'description': 'Carious primary molars will be restored using amalgam (code 4 or 5)', 'interventionNames': ['Procedure: AmaIgam']}, {'type': 'EXPERIMENTAL', 'label': 'Hall Technique Group', 'description': 'Carious primary molars will be restored using stainless steel crowns (Hall Technique).', 'interventionNames': ['Procedure: Stainless steel']}], 'interventions': [{'name': 'AmaIgam', 'type': 'PROCEDURE', 'otherNames': ['AmaIgam group'], 'description': '(AmaIgam group): 30 carious moIars, wiII be restored with (amaIgam).', 'armGroupLabels': ['Amalgam group']}, {'name': 'Stainless steel', 'type': 'PROCEDURE', 'otherNames': ['Hall Technique'], 'description': 'A pre-formed stainless steel crown will be cemented over the carious molar without extensive tooth preparation or caries removal.', 'armGroupLabels': ['Hall Technique Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41522', 'city': 'Ismailia', 'state': 'Ismailia Governorate', 'country': 'Egypt', 'facility': 'Suez Canal University، Faculty of Dentistry', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}], 'overallOfficials': [{'name': 'Mohamed S Farag, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Suez Canal University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suez Canal University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Suez canal university hospitals', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}