Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars

Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars: a Randomized Clinical Trial

The goal of this clinical trial is to clinically evaluate the performance of BioFlx in comparison to preformed zirconia crowns in the restoration of primary second molars in pediatric patients.

The main questions it aims to answer are:

Is there a difference between BioFlx crowns (Group A) and one zirconia (Group B) in terms of crown retention (primary outcome)? Is there a difference between BioFlx crowns (Group A) and one zirconia (Group B) in modified gingival index, plaque index, occlusion, surface roughness, stain resistance, wear of opposing tooth, color match, anatomic form, marginal integrity and discoloration, proximal contact, and recurrent caries at the crown margins?

Researchers will compare the clinical performance of Bioflx crowns and zirconia crowns to determine if they are similar.

Participants:

• Participants will be asked to attend two appointments. During the first visit, a BioFlx crown will be placed on the primary lower second molar, and during the second visit, a zirconia crown will be placed on the contralateral primary lower second molar.
• Participants will be recalled and evaluated after 3, 6, and 12 months.

Inclusion Criteria:

• Children aged 5-9 years old.
• American Society of Anesthesiologists Classification I or II status.
• Cooperative child.
• Obtained informed consent.
• Two primary lower second molars requiring full coverage restorations.
• Primary lower second molars in functional occlusion with the opposing tooth and have at least one contact area with an adjacent tooth.
• Primary lower second molars that can be adequately isolated.
• Pulptomized primary lower second molars.
• Primary lower second molars with multi-surface caries.

Exclusion Criteria:

• American Society of Anesthesiologists Classification higher or equal to three statuses.
• Informed consent is not obtained.
• Allergy to local anesthesia.
• Non-restorable primary lower second molars.