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

Alexandria University

Status: Enrolling

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 their age range between 6 and 8 years participated in this study. The participants are divided into three groups representing group (A) for Bioflx crown (n=15), group (B) for Zirconia crown (n=15) and group ( C) for Stainless steel crown(n=15).

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.

Also the periodontal health will be evaluated using gingival index and plaque index according to Silness and Loe. Moreover parental and child satisfaction

• will be evaluated

Enrollment: 45 estimated 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