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NCT Number: NCT07825103

Postoperative Bite Force After Bioflx and Zirconia Crowns in Children

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.

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Key information

Conditions

Bite Force Masseter Muscle Primary Molars Zirconia Crowns

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry, Tanta university

Tanta, Egypt

Location contact

shaimaa eldesouky, assistant professor

CONTACT

[email protected]

01008994242

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preformed BioFlx Crown

Procedure

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 Crown

Procedure

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

Primary outcomes

  1. Change in Occlusal Bite Force

    Time frame: Baseline (before crown placement), immediately after crown cementation, one and three months after treatment

    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).

Secondary outcomes

  1. Occlusal Contacts

    Time frame: Baseline, immediately after crown placement, and 1 and 3 month after treatment

    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

Study contacts

Contact information is provided by the study sponsor or research team.

shaimaa eldesouky, assistant professor

CONTACT

[email protected]

01008994242

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Postoperative Bite Force in Children Following Full-Crown Restoration Under General Anesthesia: A Randomized Comparative Study of Bioflx and Zirconia Crowns

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 17, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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