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Completed

NCT Number: NCT06706167

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

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.

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Key information

Conditions

Decayed Teeth Carious Lesion Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Delta University For Science and Technology

Gamasa, El Dakhleia, 11152, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stainless steel crown

Device

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 crown

Device

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 crown

Device

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

Primary outcomes

  1. Plaque accumulation

    Time frame: 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 outcomes

  1. crown retention

    Time frame: 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

Other outcomes

  1. Gingival health

    Time frame: 6 months and 12 months

    Evaluated using the bleeding index according to Löe and Silness (1963), with scores of 0 (no inflammation), 1 (mild inflammation), 2 (moderate inflammation), and 3 (severe inflammation).

Sponsors and collaborators

Lead sponsor

Delta University for Science and Technology

Other

Registry information

Official study title

Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in Primary Molars: Randomized Control Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 26, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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