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

NCT06895707 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

  • Clincal Evaluation of BioFlx Vs. Zirconia Crowns

Interventions

OTHER

BioFlx crown

NuSmile® BioFlx crown (Group A) will be placed on primary lower second molar.

OTHER

Zirconia crown

Zirconia crown (Group B) will be placed on the contralateral primary lower second molar.

Sponsors & Collaborators

  • Riyadh Elm University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2025-11-30
Completion
2027-11-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06895707 on ClinicalTrials.gov