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

NCT06895707 | Not Yet Recruiting FDA Device

• 1 other identifier: FPGRP/2024/822/1146/1065
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Crown retention

  Evaluate whether the crown is present or absent 0= present 1= absent

  3, 6, 12 months

Secondary Outcomes (11)

• Modified gingival index

  3, 6, 12 months

• Plaque index

  3, 6, 12 months

• Occlusion

  3, 6, 12 months

• Surface roughness

  3, 6, 12 months

• Stain resistance

  3, 6, 12 months

Study Arms (2)

Primary lower second molar

EXPERIMENTAL

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

Other: BioFlx crown

Contralateral primary lower second molar

ACTIVE COMPARATOR

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

Other: Zirconia crown

Interventions

BioFlx crown OTHER

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

Primary lower second molar

Zirconia crown OTHER

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

Contralateral primary lower second molar

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riyadh Elm University: lead

Central Study Contacts

Fatimah A Alsuwaiyan, BDS

CONTACT

001966508322281; fatimah.a.alsuwaiyan2022@student.riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03