Postoperative Bite Force After Bioflx and Zirconia Crowns in Children
September 16, 2026 updated by: Shaimaa Shaban Mohamed El-desouky, Tanta University
Postoperative Bite Force in Children Following Full-Crown Restoration Under General Anesthesia: A Randomized Comparative Study of Bioflx and Zirconia Crowns
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: shaimaa eldesouky, assistant professor
- Phone Number: 01008994242
- Email: shaimaaeldesouky@dent.tanta.edu.eg
Study Locations
-
-
-
Tanta, Egypt
- faculty of dentistry, Tanta university
-
Contact:
- shaimaa eldesouky, assistant professor
- Phone Number: 01008994242
- Email: shaimaaeldesouky@dent.tanta.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bioflx Crown Group
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.
|
Preformed Bioflx pediatric crowns will be used for full-coverage restoration of indicated primary molars in children undergoing comprehensive dental treatment under general anesthesia.
|
|
Active Comparator: Zirconia Crown Group
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.
|
Preformed zirconia pediatric crowns will be used for full-coverage restoration of indicated primary molars in children undergoing comprehensive dental treatment under general anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline (before crown placement), immediately after crown cementation, one and three months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline, immediately after crown placement, and 1 and 3 month after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
September 13, 2026
First Submitted That Met QC Criteria
September 13, 2026
First Posted (Actual)
September 17, 2026
Study Record Updates
Last Update Posted (Actual)
September 18, 2026
Last Update Submitted That Met QC Criteria
September 16, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- #R-PED-7-25-3213
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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