Clinical trial NCT06895707: Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars
Official title: Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clincal Evaluation of BioFlx Vs. Zirconia Crowns
Lead sponsor: Riyadh Elm University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Primary outcomes:
measure: Crown retention
timeFrame: 3, 6, 12 months
Secondary outcomes:
measure: Modified gingival index
timeFrame: 3, 6, 12 months
measure: Plaque index
timeFrame: 3, 6, 12 months
measure: Occlusion
timeFrame: 3, 6, 12 months
measure: Surface roughness
timeFrame: 3, 6, 12 months
measure: Stain resistance
timeFrame: 3, 6, 12 months
measure: Wear of opposing tooth
timeFrame: 3, 6, 12 months
measure: Color match
timeFrame: 3, 6, 12 months
measure: Anatomic form
timeFrame: 3, 6, 12 months
measure: Marginal integrity and discoloration
timeFrame: 3, 6, 12 months
measure: Proximal contact
timeFrame: 3, 6, 12 months
measure: Recurrent caries
timeFrame: 3, 6, 12 months
Other outcomes:
Locations:
Study officials:
References: