Clinical trial NCT06706167: Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in Primary Molars
Official title: Clinical Comparison Between Stainless-steel Crown, Zirconia Crown and Bioflx Crown in Primary Molars: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decayed Teeth
Carious Lesion
Keywords: primary molars
stainless steel crown
zirconia crown
bioflx crown
clinical evaluation
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research was designed as a randomized controlled trial conducted by a single operator to minimize operator-induced errors. A total sample of 75 primary molars was determined, allowing for potential dropouts, and was evenly distributed into three groups of 25. Each group recieved different crown, groups A for stianless steel crown, group B for zirconia crown and group C for Bioflx crown. At 6 and 12 months follow up, each crown was evaluated clinically such as plaque index , crown retentivity and gingival index.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Plaque accumulation
timeFrame: 6 months and 12 months
Secondary outcomes:
measure: crown retention
timeFrame: 6 months and 12 months
Other outcomes:
measure: Gingival health
timeFrame: 6 months and 12 months
Locations:
city: Gamasa
country: Egypt
facility: Delta University For Science and Technology
state: El Dakhleia
Study officials:
References:
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