Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT06968767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-13
First Post:
2025-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2025-05-05', 'studyFirstSubmitQcDate': '2025-05-05', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prepration time', 'timeFrame': 'time frame: T0: 0 basline, follow up 12 month', 'description': 'measured by stop watch per minutes'}], 'secondaryOutcomes': [{'measure': 'Occlusal wear of crown', 'timeFrame': 'T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months', 'description': 'Measure: By Modified United States Public Health System criteria\n\nCriteria:\n\nAlpha: Occlusal surface intact\n\nBravo: Wear of occlusal surface without tooth surface exposure\n\nCharlie: Wear of occlusal surface with exposure\n\nMeasure: By Modified United States Public Health System criteria\n\nCriteria:\n\nAlpha: Occlusal surface intact\n\nBravo: Wear of occlusal surface without tooth surface exposure\n\nCharlie: Wear of occlusal surface with exposure\n\nMeasure: By Modified United States Public Health System criteria\n\nCriteria:\n\nAlpha: Occlusal surface intact\n\nBravo: Wear of occlusal surface without tooth surface exposure\n\nCharlie: Wear of occlusal surface with exposure'}, {'measure': 'retention', 'timeFrame': 'Follow-up: 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months', 'description': 'Measure: By Modified United States Public Health System criteria\n\nCriteria:\n\nAlpha: Intact\n\nBravo: Chipped/loss of material\n\nCharlie: Complete loss of crown'}, {'measure': 'Gingival Health', 'timeFrame': '12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months', 'description': 'Measure: By Gingival Index\n\nScores:\n\n0: Healthy gum\n\n1. Mild inflammation and edematous gingiva, no bleeding on probing\n2. Red edematous and shiny gingiva, bleeding on probing\n3. Red edematous and ulcerated gingiva, spontaneous bleeding'}, {'measure': 'Child and parental satisfaction', 'timeFrame': 'T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months', 'description': 'Measure: By 5-point Likert scale (Units of measurement)\n\n1. Very happy\n2. Happy\n3. Neither\n4. Unhappy\n5. Very unhappy Questionnaire Type: Ordinary or N/A (Existing validated tool)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carious Primary Molars']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/38911945/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate and compare the preparation time required for Bioflx crowns versus zirconia crowns on primary molars through a randomized clinical trial.\n\n• Primary Objective: To compare the preparation time required for Bioflex crowns and zirconia crowns on primary molars in pediatric patients.\n\n• Secondary Objectives:\n\nTo evaluate the clinical performance of Bioflex crowns compared to zirconia crowns, including:\n\nRetention, Patient Satisfaction, Parental Satisfaction, Occlusal Wear and Gingival Health.\n\nthe main question it aim to answer: Is there a significant difference in the preparation time required for Bioflx crowns compared to zirconia crowns in the primary molars of pediatric patients?', 'detailedDescription': 'In pediatric dentistry, achieving efficient and aesthetic restoration of primary molars remains a significant challenge, particularly when treating young or anxious patients who may struggle with long or complex procedures. Zirconia crowns are widely used due to their durability, excellent biocompatibility, and natural tooth-like appearance, making them the gold standard for full-coverage aesthetic restorations in children. However, their placement involves extensive tooth preparation, which results in longer chair time and an increased risk of pulp exposure. These factors can negatively impact both treatment outcomes and patient behavior management.\n\nBioflex crowns have emerged as a potential alternative, offering a more flexible and user-friendly design that simplifies placement and reduces the amount of tooth preparation required. This may result in shorter procedure times and improved patient comfort. Despite these potential benefits, there is currently limited clinical evidence comparing the preparation time and efficiency of Bioflex crowns versus zirconia crowns for restoring primary molars.\n\nThis gap in knowledge makes it difficult for clinicians to make fully informed decisions about which crown system offers the best balance of procedural efficiency, aesthetics, and patient cooperation. By directly comparing Bioflex and zirconia crowns in terms of tooth preparation time and overall clinical practicality, the proposed study aims to determine whether Bioflex crowns provide a significant advantage in pediatric settings. The results could help identify the most time-efficient and effective restorative option for primary molars, ultimately improving care outcomes for pediatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children aged between 4 and 8 years with a primary molar that needs to be covered by a crown.\n\nMedically healthy children (ASA I or II according to the American Society of Anesthesiologists classification).\n\nChildren whose parent or guardian is willing to sign an informed consent.\n\nChildren whose parent or guardian are willing to comply with follow-up visits.\n\nFrankl's positive and definitely positive patient.\n\nExclusion Criteria:\n\n* Molars with severe structural loss that may compromise crown retention.\n\nChildren with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations.\n\nChildren with a history of allergies; known allergies to dental local anesthesia or to the materials used in Biofix crowns.\n\nChildren with any systemic conditions or disabilities that may affect their ability to participate in the study."}, 'identificationModule': {'nctId': 'NCT06968767', 'briefTitle': 'Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation Of Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars', 'orgStudyIdInfo': {'id': 'PT-BFC VS ZRC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A performed bioflx crown', 'description': '(Nu smile, united state) introduced Biofix Crowns and claimed as the first flexible, durable, and esthetic preformed crown for primary molars. Biofix Crowns are monochromatic, metal-free, tooth-colored crowns made up of high-strength resin polymer used in the medical device industry having high strength, flexibility, and durability. These crowns are autoclavable and are like SSC in tooth preparation as claimed by the manufacturer. Their flexibility and snap-fit technology aim to improve retention while minimizing trauma during placement.', 'interventionNames': ['Other: bioflx crown']}, {'type': 'EXPERIMENTAL', 'label': 'group B performed zirconia crown', 'description': 'NuSmile Zirconia Crowns are prefabricated, esthetic full-coverage restorations designed for primary teeth. Known for their superior strength, durability, and natural tooth-like appearance, these crowns provide an excellent alternative to traditional stainless steel crowns. Made from high-quality medical-grade zirconia, they are biocompatible, resistant to chipping, and highly polished to minimize plaque accumulation and gingival irritation.\n\nNuSmile Zirconia Crowns require significant tooth preparation for proper fit and retention. They are available in various sizes to accommodate different primary molars and anterior teeth. Their lifelike translucency and color-matching capabilities make them a preferred choice for parents and clinicians.', 'interventionNames': ['Other: zirconia crown']}], 'interventions': [{'name': 'bioflx crown', 'type': 'OTHER', 'description': "(Group A: Preformed Biofix Crown - Assigned Intervention)\n\nCrown Selection \\& Tooth Preparation:\n\nMeasure the mesiodistal width using calipers to select an appropriately sized crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the crown that closely matches the measured mesiodistal width. Select the smallest crown that preserves proximal contacts using a trial-and-error approach. If crimping is necessary, use Howe's pliers.\n\nPerform 1-1.5 mm occlusal reduction using a tapered diamond bur.\n\nReduce proximal areas by approximately 0.5 mm to clear the contact area.\n\nCrown Placement \\& Cementation:\n\nEnsure a snug fit of the selected crown. Apply a thin layer of glass ionomer cement inside the crown. Seat the crown firmly using finger pressure. Have the child bite down gently to ensure proper seating.\n\nFinal Adjustments \\& Cleanup:\n\nRemove excess cement with floss or an explorer. Verify the crown's fit, occlusion, and stability.", 'armGroupLabels': ['group A performed bioflx crown']}, {'name': 'zirconia crown', 'type': 'OTHER', 'description': 'Group B: Preformed Zirconia Crown - Assigned Intervention)\n\nCrown Selection:\n\nMeasure the mesiodistal width using calipers to select the appropriate crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the one that closely matches the mesiodistal width. Select the smallest crown that preserves proximal contacts.\n\nTooth Preparation:\n\nReduce the occlusal surface by 1.5-2 mm using a tapered diamond bur.\n\nReduce interproximal areas by 1-1.5 mm, ensuring a feather-edge finish.\n\nPerform a 1-2 mm subgingival preparation in passively placed fissure bur.\n\nCrown Placement \\& Passive Fit Check:\n\nPlace the selected crown on the prepared tooth.\n\nCementation of the Crown:\n\nApply a thin layer of glass ionomer cement inside the crown. Seat the crown with passive finger pressure. Have the child bite down gently to ensure seating.', 'armGroupLabels': ['group B performed zirconia crown']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'state': 'Egypt', 'country': 'Egypt', 'contacts': [{'name': 'faculty of dentistry cairo university', 'role': 'CONTACT', 'email': 'rec@dentistry.cu.edu.eg', 'phone': '0020223642705'}, {'name': 'hala mosaed ali alshaeri, bachelore of dental science', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of Dentistry Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'halah M alshaeri, Bachelor of Dental surgery', 'role': 'CONTACT', 'email': 'hala.mosaed@dentistry.cu.edu.eg', 'phone': '00201149038858', 'phoneExt': '002'}, {'name': 'Manal A Elshiekh, prof, phd', 'role': 'CONTACT', 'email': 'rec@dentistry.cu.edu.eg', 'phone': '0223642705', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Hala m Alshaeri, Bachelor of Dental surgery', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo university faculty of dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Halah Mosaed Ali Alshaeri', 'investigatorAffiliation': 'Cairo University'}}}}