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

Riyadh Elm University

Status: Not yet enrolling

Conditions: Clincal Evaluation of BioFlx Vs. Zirconia Crowns

Treatments: Other: Zirconia crown; Other: BioFlx crown

Study type: Interventional

Funder types: Other

Identifiers

NCT06895707

FPGRP/2024/822/1146/1065

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 5 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Primary lower second molar

Experimental group

Description:

one NuSmile® BioFlx crown will be placed on primary lower second molar.

Treatment:

Other: BioFlx crown

Contralateral primary lower second molar

Active Comparator group

Description:

one zirconia crown will be placed on the contralateral primary lower second molar.

Treatment:

Other: Zirconia crown