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

Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars: a Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Clincal Evaluation of BioFlx Vs. Zirconia Crowns
• Intervention / Treatment: Other: BioFlx crown; Other: Zirconia crown

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatimah A Alsuwaiyan, BDS; Phone Number: 001966508322281; Email: fatimah.a.alsuwaiyan2022@student.riyadh.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary lower second molar; one NuSmile® BioFlx crown will be placed on primary lower second molar.	Other: BioFlx crown; NuSmile® BioFlx crown (Group A) will be placed on primary lower second molar.
Active Comparator: Contralateral primary lower second molar; one zirconia crown will be placed on the contralateral primary lower second molar.	Other: Zirconia crown; Zirconia crown (Group B) will be placed on the contralateral primary lower second molar.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crown retention	Evaluate whether the crown is present or absent 0= present 1= absent	3, 6, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified gingival index	0= normal; mild inflammation; moderate inflammation; sever inflammation	3, 6, 12 months
Plaque index	Plaque index 0= no plaque; film at gingival margin; moderate accumulation; abundance of plaque	3, 6, 12 months
Occlusion	0= clinically ideal with crown in harmony with occlusion; clinically acceptable with crown occluding slightly high or low; clinically unacceptable and crown needs to be replaced	3, 6, 12 months
Surface roughness	0= clinically ideal with smooth crown surface; clinically acceptable with slight rough surface; clinically unacceptable with crown fracture or pitting that require replacement	3, 6, 12 months
Stain resistance	0= no staining; minor staining that can be polished; noticeable staining that cannot be polished	3, 6, 12 months
Wear of opposing tooth	0= no wear; mild wear; severe wear	3, 6, 12 months
Color match	0= no color mismatch; acceptable crown with color mismatch; unacceptable crown with color mismatch	3, 6, 12 months
Anatomic form	0= clinically ideal; clinically acceptable (slightly under/over contoured); clinically unacceptable (crown is missing or causing pain)	3, 6, 12 months
Marginal integrity and discoloration	0= clinically ideal; clinically acceptable with slight discoloration; clinically unacceptable with clear discoloration	3, 6, 12 months
Proximal contact	0= clinically ideal with acceptable resistance to the passage of floss; clinically acceptable with tight or loose passage of floss; clinically unacceptable with no contact with adjacent tooth	3, 6, 12 months
Recurrent caries	0= clinically ideal with no presence of recurrent caries 1= clinically unacceptable with evidence of recurrent caries	3, 6, 12 months

Collaborators and Investigators

• Sponsor: Riyadh Elm University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: FPGRP/2024/822/1146/1065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No