Clinical trial NCT06450093: Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars
Official title: Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Restoration
Keywords: Bioflx Crowns
Wear
Zirconia Crowns
stainless steel Crowns
periodontal changes
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 51
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will be conducted to:

Evaluate and compare the clinical success, periodontal changes, and wear of antagonist teeth for three types of prefabricated crowns in primary molars: BioFlx crowns, Zirconia crowns, and Stainless Steel crowns.

Detailed description: A randomized controlled clinical trial with three parallel groups, will be set up and reported according to the revised Consolidated Standards of Reporting Trials statement. The study will be conducted on 51 children with 51 molars aged between 4 and 7 years with a lower primary molar indicated for crown restoration. The children will be selected from the Pediatric Dental Clinic, Faculty of Dentistry, Mansoura University. They will be randomly divided into three equal groups (17 molars/each). Sequence generation and concealment will be done by a biostatistician who is not involved in the study. Group I (control group) will include stainless steel crowns, group II (study group) will include Zirconia crowns, group III (study group) will include BioFlx crowns. After obtaining the written consent form from the parents or guardians, the children will be randomly enrolled, and teeth will be assigned to the groups to receive the selected crowns. Clinical evaluation will be done concerning crown retention, color stability, secondary caries, periodontal changes, and wear of the opposing natural enamel. All crowns will be evaluated at the 3rd, 6th, 12th, and 18th months.

Eligibility criteria: Inclusion Criteria:

* Children who are free from any systemic disease.
* Children with a carious lower primary molar indicated for crown restoration.
* Teeth with an intact antagonist and neighboring primary molar.
* Cooperative children with scores 1 and 2 (positive or definitely positive) according to Frankl's behavior rating scale.

Exclusion Criteria:

* Children with extremely poor oral hygiene.
* Teeth showing radiographical furcation involvement or root resorption.
* Children with para-functional habits, bruxism, or deep bite.
* Teeth with inadequate non-restorable crown structure.

Primary outcomes:
measure: Crown retention
timeFrame: After 3, 6,12,18 months
measure: Color stability
timeFrame: After 3, 6,12,18 months
measure: Secondary caries
timeFrame: After 3, 6, 12,18 months
measure: Gingival Index (Periodontal Changes)
timeFrame: After 3, 6, 12 ,18 months
measure: Periodontal Index (Periodontal changes)
timeFrame: After 3, 6, 12 ,18 months
measure: Periodontal pocket depth (Periodontal changes)
timeFrame: After 3, 6, 12 ,18 months
measure: Wear of the opposing natural enamel.
timeFrame: After 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry, Mansoura University.
state: Dakahlia
Study officials:
References: