NCT07156838

Evaluation of Bioflex and Zirconia Crowns Versus Stainless Steel Crowns on Primary Molars: Randomized Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Accepted

Summary

• The goal of this clinical trial is to evaluate the clinical effectiveness of bioflex crowns and zirconia crowns compared to stainless steel crowns when * restoring primary molars 45 participant who their ages range between 6 and 8 years participated in this study. The participants will be divided into three groups: group (A) for Bioflex crown (n=15), group (B) for Zirconia crown (n=15) and group ( C) for Stainless steel crown(n=15). The periodontal health will be evaluated using gingival index and plaque index .Clinical success will be assessed according to the Modified United States Public Health Service Evaluation (USPHS) criteria regarding: crown retention ,marginal integrity, surface roughness and color change. Moreover, parental and child satisfaction will be evaluated.

Conditions

• Badly Decayed Primary Molars
• Preformed Pediatric Posterior Crowns

Interventions

Type	Name	Description
OTHER	bioflex crown	A preformed bioflex crown of similar size will be selected. Tooth preparation will be done using a tapered diamond bur to reduce the occlusal surface, including the central groove, by 1-1.5 mm. The proximal surfaces will be prepared by approximately 0.5 mm to clear the contact area, bioflex crown fitting and proper occlusion will be checked then it will be cemented using type-I glass ionomer cement, Any excess cement will be removed.
OTHER	zerconia crown	Occlusal reduction will be done by 1-1.5 mm using coarse football shaped diamond bur following the natural occlusal anatomy. Interproximal contacts will be opened with a tapered fissure bur. The proximal space should be enough to permit the chosen crown to fit passively. The molar will be trimmed down circumferentially 0.5-1.25 mm as needed with the use of tapered diamond burs. •About 1 to 2 mm subgingival preparation will be done to achieve a feather-edge finish line. Prepared tooth should be free from any blood or saliva. Try-in will be done using the pink crowns, to check the occlusion and Passive fit of the crown. The zirconia crown will be luted with type I glass ionemer cement. Consistent firm finger pressure will be applied during cementation, Any excess cement will be removed, and proper occlusion will be verified
OTHER	stainless steel crown	An appropriately sized preformed stainless-steel crown will be selected. Tooth preparation will involve using a tapered bur to reduce the occlusal surface by 1 to 1.5 mm, with interproximal reduction made on the mesial and distal sides. The selected crown size will be checked, and a trial fit will be conducted prior to cementation. Crimping pliers will be used, and the crown will be cemented with Type 1 glass ionomer cement. Any excess cement will be removed, and proper occlusion will be verified

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-12-17
• Completion: 2025-12-17
• First posted: 2025-09-05
• Last updated: 2026-02-13

Locations

1 site across 1 country: Egypt