Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:01 PM
Study NCT ID:
NCT03433157
Status:
UNKNOWN
Last Update Posted:
2021-03-15
First Post:
2018-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2018-02-08', 'studyFirstSubmitQcDate': '2018-02-08', 'lastUpdatePostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique', 'timeFrame': '2 years', 'description': 'Assessment of SSCs placed with two different techniques on primary molar teeth. The cooperation of children will be assessed with Frankl Scale (1:definitely negative, 2:negative, 3:positive, 4:definitely positive).\n\nEvaluation criteria will be;\n\n* spontaneous pain (absent/present);\n* tenderness to percussion/palpation (absent/present);\n* mobility (no mobility/ 1mm/ 2mm/ 3mm mobility)\n* swelling (absent/present);\n* fistula (absent/present)\n* periapical/interradicular radiolucency (absent/present);\n* widened periodontal ligament (absent/present);\n* loss of lamina dura (absent/present);\n* internal/external root resorption (absent/present)\n* the marginal adaptation of each crown: good when the margins were sealed / poor when the margins were open\n* retention of the crown (absent/ present)\n* fracture of the crown (absent/ present)\n* gingival health/gingivitis (absent/ present)\n* plaque around the crown (absent/ present)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stainless stain crowns', 'Hall technique', 'children'], 'conditions': ['Primary Teeth', 'Dental Caries', 'Dentin, Carious']}, 'referencesModule': {'references': [{'pmid': '25987388', 'type': 'BACKGROUND', 'citation': 'Innes NP, Stewart M. The Hall Technique, a Simplified Method for Placing Stainless Steel Crowns on Primary Molars, may be as Successful as Traditionally Placed Crowns. J Evid Based Dent Pract. 2015 Jun;15(2):70-2. doi: 10.1016/j.jebdp.2015.03.008. Epub 2015 Mar 28. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate and compare the clinical performance of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique', 'detailedDescription': 'Stainless Stain Crowns (SSCs) will be placed on two primary molar teeth with proximal caries, in a split mouth design. 200 patients will be included in the study. The teeth will be randomized into two groups according to the technique.\n\nGroup 1: SSCs that will be placed using Traditional Technique Group 2: SSCs that will be placed using Hall Technique The cooperation of the child during the procedure will be assessed with Frankl scale. The crowns will be evaluated at baseline and 1., 6., 12., 18., 24. months. Radiographical evaluations will be at 6.,12. and 24. months. The data will be analysed statistically using chi square test and Log-Rank test and the Kaplan-Meier survival method will be used to estimate survival percentages.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients and parents of the patients who accept to participate and sign the informed consent\n* Patients who have two first and/or second primary molars with caries affecting at least two surfaces\n* Patients who are cooperative for the dental procedure\n\nExclusion Criteria:\n\n* Patients and parents of the patients who does not accept to participate and sign the informed consent\n* Teeth that are previously restored\n* Patients with a systemic disease,\n* Patients who have orthodontic treatment\n* Teeth which have a short period of time for succedaneous teeth to erupt\n* Teeth which need vital or non-vital endodontic treatment\n* Patients and/or parents who does not accept the esthetic appearance of SSC'}, 'identificationModule': {'nctId': 'NCT03433157', 'briefTitle': 'Assessment of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Clinical and Radiological Evaluation of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique', 'orgStudyIdInfo': {'id': 'Hall vs SSC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hall technique', 'description': 'SSCs placed on primary teeth using Hall technique', 'interventionNames': ['Device: Hall technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional technique', 'description': 'SSCs placed on primary teeth using Traditional technique', 'interventionNames': ['Device: Traditional technique']}], 'interventions': [{'name': 'Hall technique', 'type': 'DEVICE', 'description': 'Metal Stainless stain crown placed with Hall technique', 'armGroupLabels': ['Hall technique']}, {'name': 'Traditional technique', 'type': 'DEVICE', 'description': 'Metal Stainless stain crown placed with Traditional technique', 'armGroupLabels': ['Traditional technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Zafer C Cehreli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zafer Cavit Cehreli, DDS, PhD', 'investigatorAffiliation': 'Hacettepe University'}}}}