Actively Recruiting
Clinical Performance and Acceptance of Bioflx Crowns: a Randomized Controlled Clinical Trial
Led by Hams Hamed Abdelrahman · Updated on 2024-11-07
62
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Managing early childhood caries in young children can be challenging for dentists, especially when high-quality treatment and child cooperation are essential. Aesthetics play a key role in treating decayed teeth, and zirconia crowns are often preferred for their appearance but require significant tooth preparation. This trial evaluates the clinical performance and acceptance of a new Bioflx crown that combines features of stainless steel and zirconia crowns to offer an alternative treatment option for pediatric patients. Participants will be randomly assigned to receive either the Bioflx crown or a traditional stainless steel crown. For the Bioflx crown, tooth preparation involves reducing the chewing surface and proximal areas with a tapered diamond bur. For the stainless steel crown, similar tooth preparations are done, and the crown is fitted, crimped, and cemented with glass ionomer cement during the procedure. This study follows participants over 12 months, with evaluations at baseline, 6 months, and 12 months. Throughout the study, researchers will assess clinical success of the crowns and parental satisfaction. Follow-up visits include checking the crown's condition and how well the child tolerates the treatment. Parental satisfaction will be monitored for about 6 months. The total participation period is up to 12 months, allowing detailed observation of the crowns' performance and acceptance in young children.
CONDITIONS
Brief Title
Clinical Performance and Acceptance of Bioflx Crowns
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A child with primary molars is indicated for full coverage.
You will not qualify if you...
- Children with any systemic disease
- Clinical or radiographic signs/symptoms of irreversible pulpitis such as abscess, fistula, spontaneous pain, mobility, furcation involvement, internal or external root resorption
- Children with poor cooperation (Frankl scale 1 or 2)
- Parents unwilling to enroll their children in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive tooth preparation followed by placement of either Bioflex crowns or stainless steel crowns.
1 treatment visit and follow-up visits at 6 months and 12 months
Trial Site Locations
Total: 1 location
1
Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, pharos University, Egypt
Alexandria, Egypt
Actively Recruiting
Research Team
R
Rabab K ElGhandour, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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