Clinical Performance and Acceptance of Bioflx Crowns

Hams Hamed Abdelrahman

Status: Enrolling

Conditions: Caries

Treatments: Other: Stainless steel crown; Other: Bioflex Crowns

Study type: Interventional

Funder types: Other

Identifiers

NCT06677983

02202409293266

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Bioflex

Experimental group

Treatment:

Other: Bioflex Crowns

SSC

Active Comparator group

Treatment:

Other: Stainless steel crown