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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-9
SponsorRiyadh Elm University

About this 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.

Eligibility criteria

Qualifiers

Children aged 5-9 years old.

American Society of Anesthesiologists Classification I or II status.

Cooperative child.

Obtained informed consent.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • BioFlx crown
  • Zirconia crown

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators