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Clinical Performance and Acceptance of Bioflx Crowns

Clinical Performance and Acceptance of Bioflx Crowns: a Randomized Controlled Clinical Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06677983
Enrollment
62
Registered
2024-11-07
Start date
2024-02-01
Completion date
2025-07-01
Last updated
2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries

Brief summary

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

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.

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 verified.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in clinical successbaseline, 6 months, and 12 monthsThe crowns were evaluated clinically according to the following criteria: 1. Length: the margin is at the gingival crest or is extended to the cemento-enamel junction. 2. Position: crown is not rotated. 3. Polish: no scratches or roughness. 4. Cement: no excess cement remains in the sulcus. If all criteria fulfilled the crown is considered acceptable clinically, if not it is considered unacceptable.
parental satisfactionthrough study completion, an average of 6 monthsThe questionnaire for assessing parental satisfaction includes four main categories for rating the aesthetic characteristics: size, shape, color, and stain. Responses will be recorded on a five-point Likert scale, ranging from 1 (not at all satisfied) to 5 (very satisfied).

Countries

Egypt

Contacts

Primary ContactRabab K ElGhandour, PhD
rabab.elghandour@pua.edu.eg01222469150

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026