NCT06968767

Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars

Evaluation Of Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate and compare the preparation time required for Bioflx crowns versus zirconia crowns on primary molars through a randomized clinical trial. • Primary Objective: To compare the preparation time required for Bioflex crowns and zirconia crowns on primary molars in pediatric patients. • Secondary Objectives: To evaluate the clinical performance of Bioflex crowns compared to zirconia crowns, including: Retention, Patient Satisfaction, Parental Satisfaction, Occlusal Wear and Gingival Health. the main question it aim to answer: Is there a significant difference in the preparation time required for Bioflx crowns compared to zirconia crowns in the primary molars of pediatric patients?

Detailed description

In pediatric dentistry, achieving efficient and aesthetic restoration of primary molars remains a significant challenge, particularly when treating young or anxious patients who may struggle with long or complex procedures. Zirconia crowns are widely used due to their durability, excellent biocompatibility, and natural tooth-like appearance, making them the gold standard for full-coverage aesthetic restorations in children. However, their placement involves extensive tooth preparation, which results in longer chair time and an increased risk of pulp exposure. These factors can negatively impact both treatment outcomes and patient behavior management. Bioflex crowns have emerged as a potential alternative, offering a more flexible and user-friendly design that simplifies placement and reduces the amount of tooth preparation required. This may result in shorter procedure times and improved patient comfort. Despite these potential benefits, there is currently limited clinical evidence comparing the preparation time and efficiency of Bioflex crowns versus zirconia crowns for restoring primary molars. This gap in knowledge makes it difficult for clinicians to make fully informed decisions about which crown system offers the best balance of procedural efficiency, aesthetics, and patient cooperation. By directly comparing Bioflex and zirconia crowns in terms of tooth preparation time and overall clinical practicality, the proposed study aims to determine whether Bioflex crowns provide a significant advantage in pediatric settings. The results could help identify the most time-efficient and effective restorative option for primary molars, ultimately improving care outcomes for pediatric patients.

Conditions

• Carious Primary Molars

Interventions

Type	Name	Description
OTHER	bioflx crown	(Group A: Preformed Biofix Crown - Assigned Intervention) Crown Selection \& Tooth Preparation: Measure the mesiodistal width using calipers to select an appropriately sized crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the crown that closely matches the measured mesiodistal width. Select the smallest crown that preserves proximal contacts using a trial-and-error approach. If crimping is necessary, use Howe's pliers. Perform 1-1.5 mm occlusal reduction using a tapered diamond bur. Reduce proximal areas by approximately 0.5 mm to clear the contact area. Crown Placement \& Cementation: Ensure a snug fit of the selected crown. Apply a thin layer of glass ionomer cement inside the crown. Seat the crown firmly using finger pressure. Have the child bite down gently to ensure proper seating. Final Adjustments \& Cleanup: Remove excess cement with floss or an explorer. Verify the crown's fit, occlusion, and stability.
OTHER	zirconia crown	Group B: Preformed Zirconia Crown - Assigned Intervention) Crown Selection: Measure the mesiodistal width using calipers to select the appropriate crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the one that closely matches the mesiodistal width. Select the smallest crown that preserves proximal contacts. Tooth Preparation: Reduce the occlusal surface by 1.5-2 mm using a tapered diamond bur. Reduce interproximal areas by 1-1.5 mm, ensuring a feather-edge finish. Perform a 1-2 mm subgingival preparation in passively placed fissure bur. Crown Placement \& Passive Fit Check: Place the selected crown on the prepared tooth. Cementation of the Crown: Apply a thin layer of glass ionomer cement inside the crown. Seat the crown with passive finger pressure. Have the child bite down gently to ensure seating.

Timeline

• Start date: 2025-06-15
• Primary completion: 2025-06-15
• Completion: 2026-06-16
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

1 site across 1 country: Egypt