Cairo University
Cairo, Giza/Egypt, 12613, Egypt
NCT Number: NCT07523776
this randomized controlled trial will compare Bioflx crowns and stainless-steel crowns in children with pulp-treated primary molars. The study will evaluate changes in vertical dimension and mean biting force after crown placement and will also assess parental satisfaction with esthetics and treatment impact. Eligible children aged 6 to 9 years will be randomly assigned in a 1:1 ratio to receive either a Bioflx crown or a stainless-steel crown. Measurements will be taken at baseline, immediately after crown placement, at 1 week, and at 4 weeks.
Trial opening soon.
Get Notified6 year–9 year
All sexes
Interventional
Not applicable
Cairo, Giza/Egypt, 12613, Egypt
Early childhood caries commonly affects primary molars and often requires full-coverage restoration after pulp therapy. Stainless steel crowns are widely used because of their durability and clinical success, but they may have limitations related to esthetics and acceptance. Bioflx crowns are a more esthetic and flexible alternative, but there is limited evidence comparing their functional performance with stainless steel crowns.
This parallel randomized controlled trial will be conducted at the outpatient clinic of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt. A total of 18 children with pulp-treated primary molars will be enrolled and randomly allocated in a 1:1 ratio to receive either a Bioflx crown or a stainless steel crown.
The primary outcome is vertical dimension alteration measured in millimetres using a digital caliper. Secondary outcomes include mean biting force distribution measured by T-Scan digital occlusal analysis, parental satisfaction with esthetics, and parental satisfaction with treatment impact assessed by 5-point Likert scale questionnaires. Outcome measurements will be recorded at baseline, immediately after crown placement, at 1 week, and at 4 weeks, with parental satisfaction assessed at 4 weeks.
The purpose of this study is to determine whether Bioflx crowns provide comparable or improved functional and esthetic outcomes compared with stainless steel crowns in pulp-treated primary molars.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aesthetic full-coverage pediatric crown used after pulp therapy of primary molars. The Bioflx crown will be selected according to tooth size, adapted following the study protocol, and cemented with resin-modified glass ionomer cement.
Preformed stainless steel full-coverage pediatric crown used after pulp therapy of primary molars. The stainless steel crown will be selected according to tooth size, adapted following the study protocol, and cemented with resin-modified glass ionomer cement
Time frame: Baseline, immediately after crown placement, 1 week, and 4 weeks
Change in inter-occlusal vertical dimension measured in millimetres using a digital caliper at baseline, immediately after crown placement, at 1 week, and at 4 weeks. Mean differences will be compared between the Bioflx crown group and the stainless steel crown group.
Time frame: Baseline, immediately after crown placement, 1 week, and 4 weeks
Occlusal force distribution on the restored tooth measured as a percentage using T-Scan digital occlusal analysis at baseline, immediately after crown placement, at 1 week, and at 4 weeks. Force distribution will be compared between the Bioflx crown group and the stainless steel crown group.
Time frame: 4 weeks
Parental ratings of the impact of treatment on the child, including comfort, chewing ability, well-being, and perceived improvement in appearance, assessed using a 5-point Likert scale questionnaire.
Contact information is provided by the study sponsor or research team.
Eman A Hassan, BDS
CONTACT
Osama A El Shahawy, PHD
CONTACT
Cairo University
Other
Vertical Dimension Changes and Mean Biting Force Following Bioflx Placement Over Pulp-treated Primary Molars Versus Stainless Steel Crowns: A Randomized Controlled Trial.
Acronym: BIOFLX-SSC-RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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