Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-06 @ 6:23 PM
Study NCT ID:
NCT03010618
Status:
UNKNOWN
Last Update Posted:
2017-07-19
First Post:
2016-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Stainless Steel Crowns Applied With Hall Technique on Occlusal Vertical Dimension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-16', 'studyFirstSubmitDate': '2016-12-31', 'studyFirstSubmitQcDate': '2017-01-04', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete canine overbite return', 'timeFrame': '30 days', 'description': 'The length of overbite between upper and lower canines will be measured at beginning of the study with marking the overlapping contact point of the upper left canine and length of a straight line to the tip of the lower left canine will be recorded in mm with a standard WHO gingival probe. Full return to this level will be considered as "Complete canine overbite return" and failure to reach this level will in 30 days will require the patient to be scheduled for an extra recall in every 2 weeks until overbite returns to the pretreatment level.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hall technique', 'stainless steel crowns', 'temporomandibular joint', 'dental caries', 'occlusion'], 'conditions': ['Caries, Dental']}, 'referencesModule': {'references': [{'pmid': '18096042', 'type': 'BACKGROUND', 'citation': 'Innes NP, Evans DJ, Stirrups DR. The Hall Technique; a randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: acceptability of the technique and outcomes at 23 months. BMC Oral Health. 2007 Dec 20;7:18. doi: 10.1186/1472-6831-7-18.'}, {'pmid': '16703041', 'type': 'BACKGROUND', 'citation': 'Innes NP, Stirrups DR, Evans DJ, Hall N, Leggate M. A novel technique using preformed metal crowns for managing carious primary molars in general practice - a retrospective analysis. Br Dent J. 2006 Apr 22;200(8):451-4; discussion 444. doi: 10.1038/sj.bdj.4813466.'}, {'pmid': '18808544', 'type': 'BACKGROUND', 'citation': 'Kindelan SA, Day P, Nichol R, Willmott N, Fayle SA; British Society of Paediatric Dentistry. UK National Clinical Guidelines in Paediatric Dentistry: stainless steel preformed crowns for primary molars. Int J Paediatr Dent. 2008 Nov;18 Suppl 1:20-8. doi: 10.1111/j.1365-263X.2008.00935.x.'}, {'pmid': '20932395', 'type': 'RESULT', 'citation': 'van der Zee V, van Amerongen WE. Short communication: Influence of preformed metal crowns (Hall technique) on the occlusal vertical dimension in the primary dentition. Eur Arch Paediatr Dent. 2010 Oct;11(5):225-7. doi: 10.1007/BF03262751.'}, {'pmid': '24913609', 'type': 'RESULT', 'citation': "Gallagher S, O'Connell BC, O'Connell AC. Assessment of occlusion after placement of stainless steel crowns in children - a pilot study. J Oral Rehabil. 2014 Oct;41(10):730-6. doi: 10.1111/joor.12196. Epub 2014 Jun 10."}]}, 'descriptionModule': {'briefSummary': "In recent years restoring carious of fractured primary teeth with stainless steel crowns (SSC) has became more popular than ever. On the other hand the traditional operative approach of complete removal of caries is steadily losing support due to successful results with materials of high microleakage resistance.\n\nTreatment time and pain control in asymptomatic teeth has always been a problem in children. Hall technique is a minimally invasive treatment protocol that doesn't require local anesthesia, use of rotating devices for caries removal to restore primary teeth with SSC.\n\nBut this protocol also raised questions in the scientific community about its possible effects on the dentition and temporomandibular joint (TMJ) for causing primary occlusal contact and increasing vertical dimension.\n\nThe aim of our research is to study the effects of Hall technique's premature occlusal contact on TMJ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* No systemical illness\n* Willing to come to control appointments\n* No symptoms of pulpal inflammation\n* To have at least 1, 3 at most dentin caries primary teeth without infection, mobility, Angle class I profile and molar relation\n* Willing to participate the study\n\nExclusion Criteria:\n\n* History of diagnosed systemic illness\n* Anterior/ posterior crossbite\n* Presence of dental pain\n* Root resorption exceeding 2/3's of the treated tooth\n* Gingival inflammation, periodontal disease\n* Signs of parafunctionism, bruxism\n* Facial asymmetry\n* Signs or symptoms of temporomandibular disfunction\n* Not willing to participate"}, 'identificationModule': {'nctId': 'NCT03010618', 'briefTitle': 'The Effects of Stainless Steel Crowns Applied With Hall Technique on Occlusal Vertical Dimension', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Hall Teknik Ile Uygulanan Paslanmaz Celik kronların Okluzal Dikey Boyuta Etkilerinin değerlendirilmesi', 'orgStudyIdInfo': {'id': '6.2016/45'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study Group', 'interventionNames': ['Other: Hall technique stainless steel crowns']}], 'interventions': [{'name': 'Hall technique stainless steel crowns', 'type': 'OTHER', 'description': 'Primary carious tooth will be treated with stainless steel crowns without local anesthesia or caries removal and the increase in the occlusal vertical dimension will be monitored in two subsequent appointments with measuring canine overbite.', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sarp Kaya, DDS,PhD, Pediatric Dentist', 'role': 'CONTACT', 'email': 'dtsarpkaya@hotmail.com', 'phone': '0212 453 17 00'}, {'name': 'Pınar Kınay Taran, DDS, Pediatric Dentist', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sarp Kaya, DDS,PhD, Pediatric Dentist', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Meltem Bakkal, DDS,PhD, Pediatric Dentist', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Sarp Kaya, DDS,PhD, Pediatric Dentist', 'role': 'CONTACT', 'email': 'dtsarpkaya@hotmail.com', 'phone': '00902124531700'}, {'name': 'Sarp Kaya, DDS,PhD, Pediatric Dentist', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pınar Kınay Taran, DDS, Pediatric Dentist', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Meltem Bakkal, DDS,PhD, Pediatric Dentist', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bezmialem Vakif University Faculty of Dentistry Department of Pediatric Dentistry', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist', 'investigatorFullName': 'Mustafa Sarp Kaya', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}