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

NCT ID: NCT06895707

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2027-11-30

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.

Conditions

Clincal Evaluation of BioFlx Vs. Zirconia Crowns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primary lower second molar

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

Group Type: EXPERIMENTAL

BioFlx crown

Intervention Type: OTHER

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

Contralateral primary lower second molar

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

Group Type: ACTIVE_COMPARATOR

Zirconia crown

Intervention Type: OTHER

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

Interventions

BioFlx crown

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

Intervention Type: OTHER

Zirconia crown

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riyadh Elm University

OTHER

Sponsor Role: lead

Responsible Party

Fatimah alsuwaiyan

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Fatimah A Alsuwaiyan, BDS

Role: CONTACT

fatimah.a.alsuwaiyan2022@student.riyadh.edu.sa

001966508322281

Other Identifiers

FPGRP/2024/822/1146/1065

Identifier Type: -

Identifier Source: org_study_id