Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in Primary Molars

Delta University for Science and Technology75 enrolled

Overview

The purpose of this clinical trial was to compare clinically three different crowns for primary molars; stainless steel crown, zirconia crown and Bioflx crown. the main questions it aims to answer are: is Bioflex crown is an alternative to stainless steel crown and zirconia crown? Seventy-five patients their age range between 3 and 8 years participated in this study. The participants are divided into three groups representing group A for stainless steel crown (n=25), group B for zirconia crown (n=25) and group C for Bioflx crown (n=25). Plaque index, crown retentivity and gingival index will be evaluated at evaluated at baseline, 6 and 12 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Decayed Teeth Carious Lesion

Interventions

Participants in this arm received a stainless steel crown for primary teeth restoration. The crowns were selected based on the clinical assessment of the patient's dental need.

Zirconia crownDEVICE

Participants in this arm received a zirconia crown for primary teeth restoration. The crowns were selected to provide a more aesthetic and durable option compared to stainless steel.

Bioflx crownDEVICE

Participants in this arm received a Bioflx crown, which is a flexible, biocompatible material often used for pediatric crowns.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patient within the age group of 3-8 years old. * Healthy children free of any systemic disease. * Pulpotomized or pulpectomized (endodontically treated) lower second primary molars. * Patients who have the behavioral rating of definitely positive or positive according to the frankl behaviour. Exclusion Criteria: * • Patient younger than 3 years old or older than 8 years old. * non-Healthy children or have any systemic disease. * primary molars with no pulpal treatment * Patients who have the behavioral rating of definitely negative or negative according to the frankl behaviour.

Locations (1)

Delta University For Science and Technology

Gamasa, El Dakhleia, Egypt

Outcomes

Primary Outcomes

Plaque accumulation

Measured using the Löe and Silness index, where each of the four surfaces of the crown (buccal, lingual, mesial, and distal) was scored from 0 to 3 (0 = no plaque, 3 = abundance of soft matter). The scores from the four areas were added and divided by four to obtain the plaque index

Time frame: 6 months and 12 months

Secondary Outcomes

crown retention

Assessed using the USPHS criteria, where "Alpha" indicated the crown was continuous with the existing anatomic form, "Bravo" indicated a missing part of the crown but not enough to expose the underlying dentin/base, and "Charlie" indicated sufficient loss of crown substance to expose the underlying dentin/base or complete loss of the crown

Time frame: 6 months and 12 months

Data from ClinicalTrials.gov

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