Postoperative Bite Force After Bioflx and Zirconia Crowns in Children

NCT07825103 | Not Yet Recruiting DMC

• 1 other identifier: #R-PED-7-25-3213
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bite Force; Masseter Muscle; Zirconia Crowns; Primary Molars

Keywords

bite force; postoperative bite force; Bioflx crown; zirconia crown; primary molar; general anethesia

Outcome Measures

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).

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

Secondary Outcomes (1)

• Occlusal Contacts

  Baseline, immediately after crown placement, and 1 and 3 month after treatment

Study Arms (2)

Bioflx Crown Group

EXPERIMENTAL

Children in this group will receive full-crown restoration of indicated primary molars using preformed Bioflx pediatric crowns during comprehensive dental treatment under general anesthesia. Occlusal bite force will be assessed before treatment and at the predefined postoperative follow-up time points using a digital occlusal analysis system.

Procedure: Preformed Bioflx Crown

Zirconia Crown Group

ACTIVE COMPARATOR

Children in this group will receive full-crown restoration of indicated primary molars using preformed zirconia pediatric crowns during comprehensive dental treatment under general anesthesia. Occlusal bite force will be assessed before treatment and at the predefined postoperative follow-up time points using a digital occlusal analysis system.

Procedure: Preformed Zirconia Crown

Interventions

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.

Bioflx Crown Group

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.

Zirconia Crown Group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

faculty of dentistry, Tanta university

Tanta, Egypt

Location

Related Publications (2)

• Abdelhafez A, Dhar V. Comparative clinical performance of stainless steel, zirconia, and Bioflx crowns in primary molars: a randomized controlled trial. BMC Oral Health. 2025 Apr 18;25(1):585. doi: 10.1186/s12903-025-05869-8.

  PMID: 40251538 RESULT

• Singh T, Devashish, Kannan A, Chopra SS, Kaur R, Sethi T, Singh R. Bite Force Distribution and Occlusal Adjustment in Stainless Steel Crowns and BioFlx Crowns of Children Aged 4-8 Years. Int J Clin Pediatr Dent. 2026 Feb;19(2):145-149. doi: 10.5005/jp-journals-10005-3407. Epub 2026 Feb 12.

  PMID: 41800000 RESULT

Central Study Contacts

shaimaa eldesouky, assistant professor

CONTACT

01008994242; shaimaaeldesouky@dent.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of pediatric dentistry, Tanta University

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

EG (1)