Clinical Performance and Acceptance of Bioflx Crowns

Not Applicable

Recruiting

• Conditions: Caries

• Registration Number: NCT06677983
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Study First Posted: 2024-11-07
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-05-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in clinical success	baseline, 6 months, and 12 months	The 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 satisfaction	through study completion, an average of 6 months	The 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).

Trial Locations

Locations (1)

Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, pharos University, Egypt; 🇪🇬 Alexandria, Egypt