Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars

Mansoura University

Status: Enrolling

Conditions: Dental Restoration

Treatments: Other: Preformed BioFlx crown; Other: Preformed zirconia crown; Other: Preformed stainless steel crown.

Study type: Interventional

Funder types: Other

Identifiers

NCT06450093

A0103024PP

Details and patient eligibility

About

This study will be conducted to:

Evaluate and compare the clinical success, periodontal changes, and wear of antagonist teeth for three types of prefabricated crowns in primary molars: BioFlx crowns, Zirconia crowns, and Stainless Steel crowns.

Full description

A randomized controlled clinical trial with three parallel groups, will be set up and reported according to the revised Consolidated Standards of Reporting Trials statement. The study will be conducted on 51 children with 51 molars aged between 4 and 7 years with a lower primary molar indicated for crown restoration. The children will be selected from the Pediatric Dental Clinic, Faculty of Dentistry, Mansoura University. They will be randomly divided into three equal groups (17 molars/each). Sequence generation and concealment will be done by a biostatistician who is not involved in the study. Group I (control group) will include stainless steel crowns, group II (study group) will include Zirconia crowns, group III (study group) will include BioFlx crowns. After obtaining the written consent form from the parents or guardians, the children will be randomly enrolled, and teeth will be assigned to the groups to receive the selected crowns. Clinical evaluation will be done concerning crown retention, color stability, secondary caries, periodontal changes, and wear of the opposing natural enamel. All crowns will be evaluated at the 3rd, 6th, 12th, and 18th months.

Enrollment: 51 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children who are free from any systemic disease.
• Children with a carious lower primary molar indicated for crown restoration.
• Teeth with an intact antagonist and neighboring primary molar.
• Cooperative children with scores 1 and 2 (positive or definitely positive) according to Frankl's behavior rating scale.

Exclusion criteria

• Children with extremely poor oral hygiene.
• Teeth showing radiographical furcation involvement or root resorption.
• Children with para-functional habits, bruxism, or deep bite.
• Teeth with inadequate non-restorable crown structure.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 3 patient groups

Group I Stainless steel crowns (control group)

Other group

Description:

It will include 17 molars that will be restored by a stainless steel crown.

Treatment:

Other: Preformed stainless steel crown.

Group II: Preformed zirconia crown (study group)

Other group

Description:

It will include 17 molars that will be restored by Zirconia crowns.

Treatment:

Other: Preformed zirconia crown

Group III: Preformed BioFlx crown (study group)

Other group

Description:

It will include 17 molars that will be restored by BioFlx crowns.

Treatment:

Other: Preformed BioFlx crown