Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:21 AM
Study NCT ID:
NCT07471360
Status:
COMPLETED
Last Update Posted:
2026-03-13
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Clinical and Radiographic Performance, and Parental and Children's Satisfaction of BioFlx Crowns in Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical performance', 'timeFrame': '24 months', 'description': 'The clinical assessment included the evaluation of oral hygiene and plaque index using the Greene and Vermillion index to evaluate oral hygiene and to score debris and dental plaque. After the patient rinsed with disclosing tablet, the discolored plaque was scored by running the side of an explorer over the buccal surface of teeth #16/55: #11/51: #26/65: and #31/71 and the lingual surface of teeth #36 or 75 and #46 or #85. While the gingival health will be evaluated using the gingival index (GI). The GI was measured using an explorer tip, gentle pressure within the sulcus of all the surfaces around each crown. The score will range from zero to three.The following parameters will assessed; the proximal contacts, resistance to dislodgment or crown fit before and after cementation, occlusion, crown staining, nature and wear of the opposing tooth, the marginal integrity using an explorer and a catch or a gap along all the margins, any changes in the surface of the crown, all in % .'}], 'secondaryOutcomes': [{'measure': 'child and parental satisfaction', 'timeFrame': '24 months', 'description': "Child and parental satisfaction survey.The questionnaire encompass an individual interview with the children and their parents/guardians in a separate setting. The participants were asked to indicate their satisfaction with the crown color, shape, size, and overall appearance on a Likert's scale from one to ten, in which one indicates very satisfied/very acceptable and ten indicates not satisfied at all/ not acceptable at all."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric dentistry', 'satisfaction', 'primary molars', 'BioFlx', 'full-coverage restoration'], 'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'Informed consent was obtained from the parents/guardians of participating children after a detailed explanation about the treatment along with possible outcomes, risks, benefits, and discomforts is provided. In addition, assent forms were obtained from the participating children who are seven years and older. The inclusion criteria included children aged 6 to 9 years who were healthy, cooperative for dental treatment with rating of "definitely positive" or "positive" using Frankl Behavioral Rating Scale, and not known to be allergic to any components of the dental materials used in the study. Participants must have a minimum of one carious primary molar that requires a full-coverage restoration, as determined clinical and radiographical inclusion criteria for primary molars. The included primary molar should be fully erupted in occlusion and functional, have at least one proximal contact with an adjacent tooth, vital or requiring vital pulp therapy, show no clinical nor radiographic signs or symptoms of periradicular pathology, exhibit normal interproximal bone levels with no more than one-third root resorption radiographically. Children with severe malocclusion and/or periodontal disease were excluded as well as children requiring comprehensive dental treatment under general anesthesia.\n\nThe treatment was provided by two trained pediatric dentistry residents following the manufacturer\'s instructions and with an assistant\'s help, under the supervision of a consultant pediatric dentist. A new set of burs were used to prepare each crown. Appropriate pain management was delivered and the crowns were prepped according to manufacturer instructions and cemented.\n\nThe clinical evaluation was assessed during preparation, immediately after placement, at 3 month and 6 month follow-up appointments utilizing the Modified United States Public Health Services (USPHS) PYGE criteria for direct clinical evaluation of restorations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children aged 6 to 9 years\n* Cooperative\n* One primary molar that requires a full-coverage restoration with at least one proximal contact with the adjacent tooth\n* No clinical or radiographic signs or symptoms of periradicular pathology\n* Normal interproximal bone levels\n* No more than one-third root resorption radiographically\n\nExclusion Criteria:\n\n* Children with severe malocclusion\n* Children with periodontal disease\n* Children requiring comprehensive dental treatment under general anesthesia.'}, 'identificationModule': {'nctId': 'NCT07471360', 'briefTitle': "Evaluation of Clinical and Radiographic Performance, and Parental and Children's Satisfaction of BioFlx Crowns in Primary Molars", 'organization': {'class': 'OTHER', 'fullName': 'King Abdulaziz University'}, 'officialTitle': "Evaluation of Clinical and Radiographic Performance, and Parental and Children's Satisfaction of BioFlx Crowns in Primary Molars: 24-Month Follow-up", 'orgStudyIdInfo': {'id': '53-03-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BioFlx crowns', 'description': 'BioFlx crowns', 'interventionNames': ['Other: Bioflx pediatric dental posterior crowns']}], 'interventions': [{'name': 'Bioflx pediatric dental posterior crowns', 'type': 'OTHER', 'description': 'Bioflx pediatric dental posterior crowns', 'armGroupLabels': ['BioFlx crowns']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'King Abdulaziz University', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to privacy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Professor', 'investigatorFullName': 'Shahad Abudawood', 'investigatorAffiliation': 'King Abdulaziz University'}}}}