Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT06706167
Status:
COMPLETED
Last Update Posted:
2024-12-04
First Post:
2024-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This research was designed as a randomized controlled trial conducted by a single operator to minimize operator-induced errors. A total sample of 75 primary molars was determined, allowing for potential dropouts, and was evenly distributed into three groups of 25. Each group recieved different crown, groups A for stianless steel crown, group B for zirconia crown and group C for Bioflx crown. At 6 and 12 months follow up, each crown was evaluated clinically such as plaque index , crown retentivity and gingival index.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-30', 'studyFirstSubmitDate': '2024-11-23', 'studyFirstSubmitQcDate': '2024-11-23', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gingival health', 'timeFrame': '6 months and 12 months', 'description': 'Evaluated using the bleeding index according to Löe and Silness (1963), with scores of 0 (no inflammation), 1 (mild inflammation), 2 (moderate inflammation), and 3 (severe inflammation).'}], 'primaryOutcomes': [{'measure': 'Plaque accumulation', 'timeFrame': '6 months and 12 months', 'description': 'Measured using the Löe and Silness index, where each of the four surfaces of the crown (buccal, lingual, mesial, and distal) was scored from 0 to 3 (0 = no plaque, 3 = abundance of soft matter). The scores from the four areas were added and divided by four to obtain the plaque index'}], 'secondaryOutcomes': [{'measure': 'crown retention', 'timeFrame': '6 months and 12 months', 'description': 'Assessed using the USPHS criteria, where "Alpha" indicated the crown was continuous with the existing anatomic form, "Bravo" indicated a missing part of the crown but not enough to expose the underlying dentin/base, and "Charlie" indicated sufficient loss of crown substance to expose the underlying dentin/base or complete loss of the crown'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary molars', 'stainless steel crown', 'zirconia crown', 'bioflx crown', 'clinical evaluation'], 'conditions': ['Decayed Teeth', 'Carious Lesion']}, 'referencesModule': {'references': [{'pmid': '25631720', 'type': 'RESULT', 'citation': 'Ashima G, Sarabjot KB, Gauba K, Mittal HC. Zirconia crowns for rehabilitation of decayed primary incisors: an esthetic alternative. J Clin Pediatr Dent. 2014 Fall;39(1):18-22. doi: 10.17796/jcpd.39.1.t6725r5566u4330g.'}, {'pmid': '33845821', 'type': 'RESULT', 'citation': "Uhlen MM, Tseveenjav B, Wuollet E, Furuholm J, Ansteinsson V, Mulic A, Valen H. Stainless-steel crowns in children: Norwegian and Finnish dentists' knowledge, practice and challenges. BMC Oral Health. 2021 Apr 12;21(1):190. doi: 10.1186/s12903-021-01556-6."}, {'pmid': '24994618', 'type': 'RESULT', 'citation': 'Schuler IM, Hiller M, Roloff T, Kuhnisch J, Heinrich-Weltzien R. Clinical success of stainless steel crowns placed under general anaesthesia in primary molars: an observational follow up study. J Dent. 2014 Nov;42(11):1396-403. doi: 10.1016/j.jdent.2014.06.009. Epub 2014 Jun 30.'}, {'pmid': '25905656', 'type': 'RESULT', 'citation': 'Seale NS, Randall R. The use of stainless steel crowns: a systematic literature review. Pediatr Dent. 2015 Mar-Apr;37(2):145-60.'}, {'type': 'RESULT', 'citation': 'Dimitrov E, Georgieva M, Andreeva RJM. Indications for use of performed crowns in pediatric dentistry. 2016;2:439-45.'}, {'pmid': '23550521', 'type': 'RESULT', 'citation': 'Katz CR, de Andrade Mdo R, Lira SS, Ramos Vieira EL, Heimer MV. The concepts of minimally invasive dentistry and its impact on clinical practice: a survey with a group of Brazilian professionals. Int Dent J. 2013 Apr;63(2):85-90. doi: 10.1111/idj.12018. Epub 2013 Mar 12.'}, {'pmid': '35830632', 'type': 'RESULT', 'citation': 'Aggarwal P, Goyel V, Mathur S, Sachdev V. Effect of Stainless-Steel Crown and Preformed Zirconia Crown on the Periodontal Health of Endodontically Treated Primary Molars Correlating with IL-1beta: An In Vivo Study. J Clin Pediatr Dent. 2022 May 1;46(3):199-203. doi: 10.17796/1053-4625-46.3.5.'}, {'pmid': '33723119', 'type': 'RESULT', 'citation': 'Kaptan A, Korkmaz E. Evaluation of success of stainless steel crowns placed using the hall technique in children with high caries risk: A randomized clinical trial. Niger J Clin Pract. 2021 Mar;24(3):425-434. doi: 10.4103/njcp.njcp_112_20.'}, {'pmid': '27377108', 'type': 'RESULT', 'citation': 'Smail-Faugeron V, Porot A, Muller-Bolla M, Courson F. Indirect pulp capping versus pulpotomy for treating deep carious lesions approaching the pulp in primary teeth: a systematic review. Eur J Paediatr Dent. 2016 Jun;17(2):107-12.'}, {'pmid': '33790544', 'type': 'RESULT', 'citation': 'Kopczynski K, Meyer BD. Examining Parental Treatment Decisions Within a Contemporary Pediatric Dentistry Private Practice. Patient Prefer Adherence. 2021 Mar 25;15:645-652. doi: 10.2147/PPA.S300684. eCollection 2021.'}, {'pmid': '40251538', 'type': 'DERIVED', 'citation': 'Abdelhafez A, Dhar V. Comparative clinical performance of stainless steel, zirconia, and Bioflx crowns in primary molars: a randomized controlled trial. BMC Oral Health. 2025 Apr 18;25(1):585. doi: 10.1186/s12903-025-05869-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial was to compare clinically three different crowns for primary molars; stainless steel crown, zirconia crown and Bioflx crown.\n\nthe main questions it aims to answer are: is Bioflex crown is an alternative to stainless steel crown and zirconia crown? Seventy-five patients their age range between 3 and 8 years participated in this study. The participants are divided into three groups representing group A for stainless steel crown (n=25), group B for zirconia crown (n=25) and group C for Bioflx crown (n=25). Plaque index, crown retentivity and gingival index will be evaluated at evaluated at baseline, 6 and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient within the age group of 3-8 years old.\n* Healthy children free of any systemic disease.\n* Pulpotomized or pulpectomized (endodontically treated) lower second primary molars.\n* Patients who have the behavioral rating of definitely positive or positive according to the frankl behaviour.\n\nExclusion Criteria:\n\n* • Patient younger than 3 years old or older than 8 years old.\n\n * non-Healthy children or have any systemic disease.\n * primary molars with no pulpal treatment\n * Patients who have the behavioral rating of definitely negative or negative according to the frankl behaviour.'}, 'identificationModule': {'nctId': 'NCT06706167', 'briefTitle': 'Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Delta University for Science and Technology'}, 'officialTitle': 'Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in Primary Molars: Randomized Control Trial', 'orgStudyIdInfo': {'id': 'DU0240721024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'stainless steel crown', 'description': 'Participants in this arm will receive stainless steel crowns for primary teeth.', 'interventionNames': ['Device: stainless steel crown', 'Device: Zirconia crown', 'Device: Bioflx crown']}, {'type': 'EXPERIMENTAL', 'label': 'zirconia crown', 'description': 'Participants in this arm will receive zirconia crowns for primary teeth.', 'interventionNames': ['Device: stainless steel crown', 'Device: Zirconia crown', 'Device: Bioflx crown']}, {'type': 'EXPERIMENTAL', 'label': 'Bioflx crown', 'description': 'Participants in this arm will receive Bioflex crowns for primary teeth.', 'interventionNames': ['Device: stainless steel crown', 'Device: Zirconia crown', 'Device: Bioflx crown']}], 'interventions': [{'name': 'stainless steel crown', 'type': 'DEVICE', 'description': "Participants in this arm received a stainless steel crown for primary teeth restoration. The crowns were selected based on the clinical assessment of the patient's dental need.", 'armGroupLabels': ['Bioflx crown', 'stainless steel crown', 'zirconia crown']}, {'name': 'Zirconia crown', 'type': 'DEVICE', 'description': 'Participants in this arm received a zirconia crown for primary teeth restoration. The crowns were selected to provide a more aesthetic and durable option compared to stainless steel.', 'armGroupLabels': ['Bioflx crown', 'stainless steel crown', 'zirconia crown']}, {'name': 'Bioflx crown', 'type': 'DEVICE', 'description': 'Participants in this arm received a Bioflx crown, which is a flexible, biocompatible material often used for pediatric crowns.', 'armGroupLabels': ['Bioflx crown', 'stainless steel crown', 'zirconia crown']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11152', 'city': 'Gamasa', 'state': 'El Dakhleia', 'country': 'Egypt', 'facility': 'Delta University For Science and Technology', 'geoPoint': {'lat': 31.44112, 'lon': 31.53675}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We are currently reviewing the potential for sharing individual participant data (IPD) following the completion of the study. Factors such as data privacy, participant consent, and regulatory guidelines are being considered. A final decision on data sharing will be made at the conclusion of the study, and the IPD sharing plan will be updated accordingly'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Delta University for Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}