Clinical Performance and Acceptance of Bioflx Crowns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bioflex Crowns, Stainless steel crown.
- Who it may be relevant to
- Registry conditions: Caries. Basic parameters: 4 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Performance and Acceptance of Bioflx Crowns: a Randomized Controlled Clinical Trial
Overview
Treating pediatric patients with early childhood caries can be challenging. For clinicians, managing a young child while ensuring high-quality treatment is difficult. It is essential to have the best equipment and materials available. Today, aesthetics are crucial in managing decayed teeth, with zirconia crowns often preferred for their visual appeal, although they require substantial preparation. The newly developed Bioflx crown, combining stainless steel and zirconia properties, offers an alternative solution.
Interventions
- Other Bioflex Crowns
A preformed crown of similar size will be selected. Tooth preparation will be done using a tapered diamond bur to reduce the occlusal surface, including the central groove, by 1-1.5 mm. The proximal surfaces will be prepared by approximately 0.5 mm to clear the contact area. - Other Stainless steel crown
An appropriately sized preformed stainless-steel crown will be selected. Tooth preparation will involve using a tapered bur ) to reduce the occlusal surface by 1 to 1.5 mm, with interproximal reduction made on the mesial and distal sides. The selected crown size will be checked, and a trial fit will be conducted prior to cementation. Crimping pliers will be used, and the crown will be cemented with Type 1 glass ionomer cement. Any excess cement will be removed, and proper occlusion will be verif
Primary outcome measures
- Change in clinical success [Time frame: baseline, 6 months, and 12 months]
- parental satisfaction [Time frame: through study completion, an average of 6 months]
Eligibility criteria
Inclusion criteria
- A child with primary molars is indicated for full coverage.
Exclusion criteria
- Children with any systemic disease
- Clinical or radiographic signs/symptoms of irreversible pulpitis as abscess, fistula, spontaneous pain, mobility, furcation involvement, internal or external root resorption
- Children cooperation (1,2) according to Frankl scale
- Parents are unwilling to enroll their children in study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, pharos University, Egypt — Alexandria
Identifiers
NCT: NCT06677983 · 02202409293266