Actively Recruiting
Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars: A Randomized Controlled Clinical Trial
Led by Mansoura University · Updated on 2024-06-10
51
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical success, gum health changes, and wear on opposing teeth of three types of prefabricated crowns used on primary molars in children. This study compares BioFlx crowns, Zirconia crowns, and Stainless Steel crowns in children aged 4 to 7 years who need crown restoration on a lower primary molar. The trial is a randomized controlled clinical study involving 51 children divided into three groups, conducted to provide detailed comparisons of these dental restoration options. The trial includes three groups: one receiving stainless steel crowns, the second receiving zirconia crowns, and the third receiving BioFlx crowns. Each crown type involves specific tooth preparation and cementation procedures using self-cured resin-modified glass ionomer cement. Treatments will be given after careful tooth preparation, fitting, and cementation. Evaluations of the crowns will be made at 3, 6, 12, and 18 months after placement to assess retention, color stability, secondary caries, and periodontal changes. Wear of the opposing natural enamel will be assessed after 12 months. Participants will undergo regular dental check-ups at specified intervals to monitor crown performance and oral health. Assessments include clinical evaluations of crown retention, color stability, occurrence of secondary cavities, and periodontal health using gingival and periodontal indices along with pocket depth measurements. The study also tracks wear on the opposing natural teeth. The total participation period spans 18 months with evaluations at multiple time points to gather comprehensive data on crown durability and oral effects.
CONDITIONS
Brief Title
Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
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.
1 visit (in-person)
Duration - Single treatment visit with crown placement
Participants receive a crown restoration on a primary molar with either a stainless steel, zirconia, or BioFlx crown.
1 visit (in-person)
Duration - 18 months
Participants are evaluated for crown retention, color stability, secondary caries, periodontal changes, and wear of the opposing natural enamel at multiple time points.
Visits at 3, 6, 12, and 18 months after crown placement
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry, Mansoura University.
Al Mansurah, Dakahlia Governorate, Egypt, 35516
Actively Recruiting
Research Team
H
Heba 0. Elbadry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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