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

D

Delta University for Science and Technology

Status

Completed

Conditions

Decayed Teeth
Carious Lesion

Treatments

Device: Zirconia crown
Device: Bioflx crown
Device: stainless steel crown

Study type

Interventional

Funder types

Other

Identifiers

NCT06706167
DU0240721024

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

3 to 8 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

75 participants in 3 patient groups

stainless steel crown
Active Comparator group
Description:
Participants in this arm will receive stainless steel crowns for primary teeth.
Treatment:
Device: stainless steel crown
Device: Bioflx crown
Device: Zirconia crown
zirconia crown
Experimental group
Description:
Participants in this arm will receive zirconia crowns for primary teeth.
Treatment:
Device: stainless steel crown
Device: Bioflx crown
Device: Zirconia crown
Bioflx crown
Experimental group
Description:
Participants in this arm will receive Bioflex crowns for primary teeth.
Treatment:
Device: stainless steel crown
Device: Bioflx crown
Device: Zirconia crown

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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