Early Childhood CariesDental CariesPulp-Treated Primary Molars
Investigational drug(s) / intervention(s)
Bioflx CrownStainless Steel Crown
Bioflx Crown: 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.
Stainless Steel Crown: 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
Study summary
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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
9 Years
Healthy volunteers
No
Inclusion Criteria:
* Pulp-treated primary molars (pulpotomy)
* Asymptomatic teeth after pulp therapy with no signs of infection, mobility, or radiographic pathology, such as internal resorption or periapical lesions
* Age 6 years to 9 years
* Male or female
* Cooperative child with positive Frankl behavior rating
* No missing teeth
* Normal occlusion, including normal overjet and overbite
* Free from systemic disease to allow continuity of follow-up
Exclusion Criteria:
* Medically compromised or uncooperative children
* Tooth indicated for extraction because of root resorption, teeth near exfoliation, or deep subgingival caries that prevents proper coronal seal
* Teeth with more than two-thirds root resorption
* Previous pulp therapy
* Parafunctional habits, including bruxism, thumb-sucking, or other habits that may affect occlusal force measurements
* Inability to attend follow-up visits or parental refusal to participate
Primary outcome measure(s)
Vertical dimension alterations — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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