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

Not Applicable

Not yet recruiting

• Conditions: Clincal Evaluation of BioFlx Vs. Zirconia Crowns

• Registration Number: NCT06895707
• Lead Sponsor: Riyadh Elm University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-30
• Study Start: 2025-05
• Primary Completion: 2025-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Crown retention	3, 6, 12 months	Evaluate whether the crown is present or absent 0= present; 1= absent

Secondary Outcome Measures

Name	Time	Method
Modified gingival index	3, 6, 12 months	0= normal; 1. mild inflammation; 2. moderate inflammation; 3. sever inflammation
Plaque index	3, 6, 12 months	Plaque index 0= no plaque; 1. film at gingival margin; 2. moderate accumulation; 3. abundance of plaque
Occlusion	3, 6, 12 months	0= clinically ideal with crown in harmony with occlusion; 1. clinically acceptable with crown occluding slightly high or low; 2. clinically unacceptable and crown needs to be replaced
Surface roughness	3, 6, 12 months	0= clinically ideal with smooth crown surface; 1. clinically acceptable with slight rough surface; 2. clinically unacceptable with crown fracture or pitting that require replacement
Stain resistance	3, 6, 12 months	0= no staining; 1. minor staining that can be polished; 2. noticeable staining that cannot be polished
Wear of opposing tooth	3, 6, 12 months	0= no wear; 1. mild wear; 2. severe wear
Color match	3, 6, 12 months	0= no color mismatch; 1. acceptable crown with color mismatch; 2. unacceptable crown with color mismatch
Anatomic form	3, 6, 12 months	0= clinically ideal; 1. clinically acceptable (slightly under/over contoured); 2. clinically unacceptable (crown is missing or causing pain)
Marginal integrity and discoloration	3, 6, 12 months	0= clinically ideal; 1. clinically acceptable with slight discoloration; 2. clinically unacceptable with clear discoloration
Proximal contact	3, 6, 12 months	0= clinically ideal with acceptable resistance to the passage of floss; 1. clinically acceptable with tight or loose passage of floss; 2. clinically unacceptable with no contact with adjacent tooth
Recurrent caries	3, 6, 12 months	0= clinically ideal with no presence of recurrent caries; 1= clinically unacceptable with evidence of recurrent caries