Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:52 AM
Study NCT ID:
NCT07357402
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2026-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes and Satisfaction of Stainless Steel vs Bioflx Crowns in Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study is designed as a randomized split-mouth clinical trial. Each child will receive both types of crowns on two similar teeth on opposite sides of the mouth. One side is randomly assigned to receive a stainless steel crown, and the other side receives a Bioflx crown. The placement of the two crowns is performed in two separate appointments, with an interval of 1 to 2 weeks between them. This approach allows the child to adapt to the new occlusion (bite) after the first crown is placed, ensuring a more stable result before the second procedure.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-20', 'studyFirstSubmitDate': '2026-01-17', 'studyFirstSubmitQcDate': '2026-01-20', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- Clincal outcomes: crown stability; bite discomfort; fit and color changes at the crown edge; crown shape; crown retention; crown wear; wear of the opposing tooth or crown - Oral hygiene and gum health around the crowns', 'timeFrame': '- Crown stability, bite discomfort, fit and color at the crown margin, and crown shape were checked after crown placement, at 3 months, and at 6 months follow-up visits. Others were checked at 3, 6 months, except secondary caries was checked at 6 months', 'description': '* Each clinical parameter was assessed using the modified United States Public Health Service (USPHS) criteria.\n\n * Outcomes were rated on a three-level scale (Alpha, Bravo, Charlie), where Alpha indicates an ideal condition, Bravo an acceptable condition with minor defects, and Charlie an unacceptable condition requiring repair or replacement. For analysis, Alpha and Bravo scores were considered acceptable, while Charlie scores were considered failures.\n * Secondary caries were assessed using periapical radiographs, while all other clinical parameters were assessed by dental explorer and documented using photographs (Canon 6D camera).\n* This outcome evaluates how clean the teeth are and how healthy the gums are around crowned teeth. Plaque and gum condition were evaluated using standard dental indices (Plaque Index and Gingival Index). Dentists exam by using a periodontal probe at six points around the crowns, and the scores were combined to provide an overall result.'}], 'secondaryOutcomes': [{'measure': 'parent and child satisfaction', 'timeFrame': 'From immediately after crowns placement through the 3-month and 6-month follow-up visits.', 'description': "* Children's and parents' satisfaction are assessed using two separate questionnaires, both employing a 5-point Likert scale with scores ranging from 1 to 5 (Units on a Scale). For children, a facial expression Likert scale is used.\n* The Likert scale levels are defined as follows:\n\n 1. \\- Very dissatisfied\n 2. \\- Dissatisfied\n 3. \\- Neutral\n 4. \\- Satisfied\n 5. \\- Very satisfied\n* Higher scores indicate greater satisfaction\n* Parent questionnaire includes the following items: size, shape, color of two crowns; child's ability to eat a variety of foods after treatment and overall parental satisfaction.\n* Another questionnaire scale based on children ratings of treatment on them consists of five categories, including 1) Appearance of the teeth before crown placement; 2) Crowns have improved the appearance of the child's teeth; 3) The child avoided smiling before crowns; 4) Child smiling after crowns; 5) The oral health of the child improved after crowns."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Stainless steel crowns', 'Bioflx crowns', 'Primary molars', 'Split-mouth study', 'Parental and child satisfaction'], 'conditions': ['Severely Decayed Primary Molars Requiring Full-Coverage Crowns']}, 'referencesModule': {'references': [{'pmid': '41126408', 'type': 'BACKGROUND', 'citation': 'Tin BT, Phuong NTM, Anh NTH, Bau TH, Dong TT, Ngoc VTN. Short-Term Clinical Evaluation of Bioflx Crowns for Primary Molar Restoration in Children Aged 4-8 Years in Vietnam: A Pilot Observational Study. Int J Paediatr Dent. 2026 Jan;36(1):187-194. doi: 10.1111/ipd.70039. Epub 2025 Oct 22.'}, {'pmid': '32509626', 'type': 'BACKGROUND', 'citation': 'Mathew MG, Roopa KB, Soni AJ, Khan MM, Kauser A. Evaluation of Clinical Success, Parental and Child Satisfaction of Stainless Steel Crowns and Zirconia Crowns in Primary Molars. J Family Med Prim Care. 2020 Mar 26;9(3):1418-1423. doi: 10.4103/jfmpc.jfmpc_1006_19. eCollection 2020 Mar.'}, {'pmid': '31445509', 'type': 'BACKGROUND', 'citation': 'Lopez-Cazaux S, Aiem E, Velly AM, Muller-Bolla M. Preformed pediatric zirconia crown versus preformed pediatric metal crown: study protocol for a randomized clinical trial. Trials. 2019 Aug 24;20(1):530. doi: 10.1186/s13063-019-3559-1.'}, {'pmid': '28494606', 'type': 'BACKGROUND', 'citation': 'Pozos-Guillen A, Chavarria-Bolanos D, Garrocho-Rangel A. Split-mouth design in Paediatric Dentistry clinical trials. Eur J Paediatr Dent. 2017 Mar;18(1):61-65. doi: 10.23804/ejpd.2017.18.01.13.'}, {'pmid': '38616425', 'type': 'BACKGROUND', 'citation': 'Patil AS, Jain M, Choubey S, Patil M, Chunawala Y. Comparative evaluation of clinical success of Stainless Steel and Bioflx crowns in primary molar - A 12 month split mouth prospective randomized clinical trial. J Indian Soc Pedod Prev Dent. 2024 Jan 1;42(1):37-45. doi: 10.4103/JISPPD.JISPPD_484_23. Epub 2024 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if the Bioflx crown (a tooth-colored material) is as effective as the standard stainless steel crown for treating severely decayed baby back teeth in children aged 4 to 10 years old. The study also aims to evaluate parent and child satisfaction with these restorative options.\n\nThe main questions it aims to answer are:\n\n1. Is the Bioflx crown as effective as the stainless steel crown in terms of durability, staying in place, and protecting the tooth from new decay?\n2. Does the Bioflx crown maintain better gum health and cause less wear on the opposing teeth compared to the stainless steel crown?\n\nResearchers will compare the Bioflx crown to the stainless steel crown to see which material works better to restore tooth function and health.\n\nParticipants will:\n\n1. Receive one Bioflx crown and one stainless steel crown on similar teeth on opposite sides of the mouth.\n2. Visit the clinic for two separate appointments, spaced 1 to 2 weeks apart, to have the crowns placed.\n3. Return for checkups at 3 months and 6 months so researchers can examine the health of the teeth and gums.\n4. Answer questions about how happy they are with the appearance and feel of the crowns.', 'detailedDescription': 'The standard treatment for fixing severely decayed baby back teeth is the stainless steel crown, which is a durable metal cap. While these metal crowns work very well, many parents and children prefer a more natural, tooth-colored look. This study tests a newer option called the Bioflx crown, which is made of a flexible, tooth-colored material.\n\nThe Treatment Process The crowns are placed during two separate visits, usually 1 to 2 weeks apart. It gives the child time to get used to the first crown and ensures their bite is comfortable before the second one is placed. It makes the appointments shorter and easier for the child to handle. The side of the mouth that gets the metal crown and the side that gets the tooth-colored crown is randomized.\n\nHow Success is Measured\n\nAfter the crowns are placed, researchers will check them again at 3 months and 6 months. They will use professional standards to evaluate the effectiveness of the crowns, focusing on:\n\n1. Durability: Do the crowns stay glued to the teeth and resist wearing down from chewing?\n2. Prevention: Does the new material prevent new cavities from forming at the edges of the crown?\n3. Gum Health: Do the gums around the tooth stay healthy, or do they become red and swollen?\n4. Satisfaction: How do the child and parent feel about the color, size, and shape of the tooth-colored crown compared to the metal one?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with at least two carious primary molars located on both the right and left sides of the dental arch and indicated for crown placement\n* Children and their parents have ability to communicate in Vietnamese\n* Primary molars indicated for full-coverage crown restoration, including teeth with:\n\n * Multi-surface caries\n * Extensive caries or enamel-dentin defects\n * Interproximal caries\n * High risk of failure with other restorative materials\n * Teeth following pulpotomy or pulpectomy\n\nExclusion Criteria:\n\n* Uncooperative children\n* Presence of psychiatric or neurological disorders affecting communication ability\n* Malocclusion (crossbite or scissors bite)\n* Having abnormal parafunctional habits\n* Teeth with root resorption exceeding one half of the root length'}, 'identificationModule': {'nctId': 'NCT07357402', 'briefTitle': 'Clinical Outcomes and Satisfaction of Stainless Steel vs Bioflx Crowns in Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'University of Medicine and Pharmacy at Ho Chi Minh City'}, 'officialTitle': 'Comparison of Clinical Outcomes, Parent and Child Satisfaction Between Stainless Steel Crowns and Prefabricated Hybrid (Bioflx) Crowns in Primary Molars', 'orgStudyIdInfo': {'id': '3526/QĐ-ĐHYD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stainless steel crown', 'description': 'Participants receive a prefabricated stainless steel crown placed on a primary molar according to standard pediatric dental procedures. The crown is selected, adapted, and cemented following conventional clinical protocols and serves as the standard treatment comparator in this study.', 'interventionNames': ['Device: Stainless Steel Crown']}, {'type': 'EXPERIMENTAL', 'label': 'Bioflx crown', 'description': 'Participants receive a prefabricated Bioflx crown placed on a primary molar using manufacturer-recommended techniques. The crown is selected and cemented following standardized clinical procedures and is evaluated as the experimental intervention for clinical performance and patient-related outcomes.', 'interventionNames': ['Device: Bioflx crown']}], 'interventions': [{'name': 'Stainless Steel Crown', 'type': 'DEVICE', 'description': 'Stainless steel crowns are prefabricated metal crowns that have been widely and long used in pediatric dentistry to restore primary molars with extensive caries or following pulp therapy.', 'armGroupLabels': ['Stainless steel crown']}, {'name': 'Bioflx crown', 'type': 'DEVICE', 'description': 'Bioflx crowns are prefabricated tooth-colored polymer crowns designed to improve esthetics compared with conventional stainless steel crowns', 'armGroupLabels': ['Bioflx crown']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700000', 'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'University of Medicine and Pharmacy at Ho Chi Minh City', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}, {'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'University of Medicine and Pharmacy at Ho Chi Minh City', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Huong Thi Nguyen Nguyen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PHAM LE ANH THY', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dentist', 'investigatorFullName': 'PHAM LE ANH THY', 'investigatorAffiliation': 'University of Medicine and Pharmacy at Ho Chi Minh City'}}}}