RecruitingNot ApplicableNCT06677983

Clinical Performance and Acceptance of Bioflx Crowns

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


Sponsor

Hams Hamed Abdelrahman

Enrollment

62 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 4 YearsMax Age: 8 Years

Inclusion Criteria1

  • A child with primary molars is indicated for full coverage.

Exclusion Criteria4

  • 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

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Interventions

OTHERBioflex 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.

OTHERStainless 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.


Locations(1)

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

Alexandria, Egypt

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NCT06677983


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