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NCT07902570
3D-Printed Resin Crowns Versus Bioflx Crowns in Primary Molars
Conditions: Dental Restorations in Children, Pediatric Dentistry
Sex: All
Ages: 3 Years – 9 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 18
Sponsor: Faculty of Dental Medicine for Girls
Summary
This randomized comparative clinical trial will evaluate and compare the clinical performance of preformed three-dimensional (3D)-printed resin crowns and Bioflx crowns in children with pulp-treated primary molars requiring full coronal restoration. The study will use a split-mouth design in which eligible children have two comparable contralateral primary molars treated with the two crown types, with the crown allocation to the right or left tooth determined by a computer-generated random sequence. Crown survival will be the primary outcome. Secondary outcomes will include the modified plaque index, modified gingival index, and occlusal wear. Clinical assessments are planned at one week and at 3, 6, and 12 months after treatment.
Eligibility Criteria
Inclusion Criteria:
Children of both sexes aged 3-9 years. Systemically healthy children. Children with at least two comparable contralateral primary molars requiring pulp therapy and full coronal coverage.
Children with a Frankl behavior rating of definitely positive or positive.
Exclusion Criteria:
Children with disabilities or systemic diseases. Primary molars with pathological discrepancies in root resorption. Primary molars with furcation inflammation. Children with oral parafunctional habits. Primary molars with root caries. Children with temporomandibular joint disorders. Primary molars expected to undergo physiological exfoliation within 24 months. Children with a Frankl behavior rating of negative or definitely negative.
Source: ClinicalTrials.gov (NCT07902570). StuddyBuddy aggregates publicly available trial information.