Clinical Performance and Acceptance of Bioflx Crowns

NCT ID: NCT06677983

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-07-01

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.

Conditions

Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bioflex

Group Type: EXPERIMENTAL

Bioflex Crowns

Intervention Type: OTHER

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.

SSC

Group Type: ACTIVE_COMPARATOR

Stainless steel crown

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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 verified.

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant Lecturer of Dental Public Health and biostatistical consultanat

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, pharos University, Egypt

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Rabab K ElGhandour, PhD

Role: CONTACT

rabab.elghandour@pua.edu.eg

01222469150

Facility Contacts

Pharos univeristy

Role: primary

3877700

Other Identifiers

02202409293266

Identifier Type: -

Identifier Source: org_study_id