Postoperative Bite Force After Bioflx and Zirconia Crowns in Children

N/ANot Yet RecruitingNCT07825103

Tanta University30 enrolled

Overview

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.

This randomized clinical trial aims to compare postoperative occlusal bite force following full-crown restoration of primary molars with preformed Bioflx and zirconia crowns in children undergoing comprehensive dental treatment under general anesthesia. Children aged 4-7 years who require full-coverage crown restoration of primary molars will be randomly allocated to receive either a preformed Bioflx crown or a zirconia crown. The crowns will be fitted and cemented according to the respective manufacturers' recommendations, and the final occlusion will be evaluated following crown placement. Occlusal bite force will be assessed before treatment and at predetermined postoperative follow-up time points using a digital occlusal analysis system. The study will compare changes in bite force following restoration with Bioflx and zirconia crowns to evaluate the recovery of occlusal function after comprehensive dental treatment under general anesthesia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Interventions

Preformed Bioflx CrownPROCEDURE

Preformed 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 CrownPROCEDURE

Preformed zirconia pediatric crowns will be used for full-coverage restoration of indicated primary molars in children undergoing comprehensive dental treatment under general anesthesia.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 7 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 treatment

Secondary Outcomes

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 treatment