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

Not Applicable

Completed

• Conditions: Decayed Teeth; Carious Lesion

• Registration Number: NCT06706167
• Lead Sponsor: Delta University for Science and Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-23
• Study First Submitted QC: 2024-11-23
• Study First Posted: 2024-11-26
• Last Update Submitted: 2024-11-30
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plaque accumulation	6 months and 12 months	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

Secondary Outcome Measures

Name	Time	Method
crown retention	6 months and 12 months	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

Trial Locations

Locations (1)

Delta University For Science and Technology; 🇪🇬 Gamasa, El Dakhleia, Egypt