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NCT07825103
Postoperative Bite Force After Bioflx and Zirconia Crowns in Children
Conditions: Bite Force, Masseter Muscle, Zirconia Crowns, Primary Molars
Sex: All
Ages: 4 Years – 7 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Tanta University
Location: faculty of dentistry, Tanta university Tanta
Summary
This randomized clinical trial aims to compare postoperative bite force following full-crown restoration with preformed Bioflx and zirconia crowns in children undergoing comprehensive dental treatment under general anesthesia. Children aged 4-7 years requiring full-coverage restoration of primary molars will be randomly allocated to receive either Bioflx or zirconia crowns. Occlusal bite force will be assessed before treatment and at predefined postoperative follow-up time points using a digital occlusal analysis system. The study will evaluate changes in occlusal function following placement of the two types of pediatric full-coverage crowns.
Eligibility Criteria
Inclusion Criteria:
* Children aged 4-7 years.
* Children requiring comprehensive dental treatment under general anesthesia.
* Children requiring full-coverage restoration of one or more primary molars with a preformed pediatric crown.
* Primary molars with sufficient remaining tooth structure to support full-crown restoration.
* Children with a generally healthy medical status and suitable for treatment under general anesthesia.
* Parents or legal guardians willing to provide written informed consent for participation in the study.
Exclusion Criteria:
* Children with systemic diseases or medical conditions that may affect oral health, occlusal function, or the ability to undergo general anesthesia.
* Children with craniofacial anomalies or developmental conditions that may significantly affect occlusion or bite force.
* Primary molars with inadequate remaining tooth structure for full-crown restoration.
* Teeth with advanced pathological root resorption or other conditions contraindicating crown restoration.
* Children with significant parafunctional habits, such as severe bruxism, that may affect bite-force measurements.
Source: ClinicalTrials.gov (NCT07825103). StuddyBuddy aggregates publicly available trial information.