Postoperative Bite Force After Bioflx and Zirconia Crowns in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-7
SponsorTanta University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Preformed Bioflx Crown
Procedure/SurgeryPreformed Bioflx pediatric crowns will be used for full-coverage restoration of indicated primary molars in children undergoing comprehensive dental treatment under general anesthesia.
Preformed Zirconia Crown
Procedure/SurgeryPreformed zirconia pediatric crowns will be used for full-coverage restoration of indicated primary molars in children undergoing comprehensive dental treatment under general anesthesia.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Bioflx Crown GroupExperimental treatment 1 intervention
Group B: Zirconia Crown GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Occlusal Bite Force
Change in occlusal bite force following full-crown restoration with preformed Bioflx or zirconia crowns, measured using a digital occlusal analysis system. Bite force will be expressed as the percentage (%) of total occlusal force contributed by the treated/restored primary molar(s).
Time frame
Baseline (before crown placement), immediately after crown cementation, one and three months after treatmentSecondary outcomes
1
Occlusal Contacts
The number and distribution of occlusal contacts, including the presence or absence of premature occlusal contacts (number of patients/teeth with premature contacts), will be assessed using digital intraoral scanning and digital occlusal analysis
Time frame
Baseline, immediately after crown placement, and 1 and 3 month after treatmentSponsors and contacts
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Source ClinicalTrials.gov
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