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

Alexandria University

Status: Completed

Conditions: Badly Decayed Primary Molars; Preformed Pediatric Posterior Crowns

Treatments: Other: zerconia crown; Other: stainless steel crown; Other: bioflex crown

Study type: Interventional

Funder types: Other

Identifiers

NCT07156838

1003-11/2024

Details and patient eligibility

About

• 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.

Enrollment: 45 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children who are free from any systemic disease.
• Cooperative children (positive/ definitely positive) according to Frankl's behavior rating scale.
• Children with good to fair oral hygiene according to Loe and Silness plaque index.
• Primary molars with deep carious lesion, that are indicated for pulpotomy and crown.
• Primary molars having two-thirds of root structure left radiographically
• Parents' willingness to participate through informed written consent

Exclusion criteria

• Children with oral parafunctional habits.
• Primary molars with bifurcation involvement
• Presence of abscess or fistula related to the selected tooth
• Primary molars with insufficient crown structure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

bioflex crown

Experimental group

Treatment:

Other: bioflex crown

zerconia crown

Experimental group

Treatment:

Other: zerconia crown

stainless steel crown

Active Comparator group

Treatment:

Other: stainless steel crown