Bite Force Recovery Following Pediatric Full Crown Restorations

August 26, 2026 updated by: Shaimaa Shaban Mohamed El-desouky, Tanta University

Bite Force Recovery Following Pediatric Full Crown Restorations: A Comparative Study of Bioflx and Stainless-steel Crowns

A component of masticatory function is bite force. Dental caries is one factor that contributes to poor dental health, which has an overall negative influence on quality of life. Caries has a detrimental after effect of functional impairment. this study aims to evaluate how children occlusal bite forces are affected by complete dental care. thirty children with dental caries in their primary molars, ages 5 to 8, of both sexes will be included. Occlusal force gauge was used to measure the occlusal bite force in the vicinity of primary molars both before and after restorations. A statistical analysis was performed on the collected data

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This controlled, randomized clinical trial aims to compare the recovery of occlusal function following restoration of primary molars with preformed BioFlx crowns and stainless steel crowns in children aged 5-8 years. thirty eligible children requiring full-coverage crown restorations of primary molars will be randomly allocated to receive either a BioFlx crown or a stainless steel crown. Occlusal bite force, occlusal contact distribution, vertical dimension, and masseter muscle activity assessed by surface electromyography will be evaluated before treatment, immediately after crown placement, and during follow-up. Clinical evaluations will also be performed at 1and 3 months.

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

Study Locations

  • Egypt
    • Cairo Governorate
      • Tanta, Cairo Governorate, Egypt, 31527

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 5-8 years.
  • Healthy and cooperative children who are able to tolerate the required dental procedures and follow-up visits.
  • Children requiring full-coverage crown restoration of a primary molar due to extensive or multisurface caries, wide proximal carious lesions
  • Primary molars requiring pulp therapy followed by full-coverage restoration.
  • Primary molars with more than one-third of the root structure remaining radiographically.
  • Children with normal molar relationship.
  • Children with normal overjet and overbite.
  • Children without clinically evident malocclusion.
  • Children without parafunctional oral habits.

Exclusion Criteria:

  • Temporomandibular joint disorders
  • Apparent facial asymmetry.
  • Uncontrolled systemic disease or medical condition that may affect participation in the study or the dental treatment.
  • Current or previous orthodontic treatment that may influence occlusion or bite-force measurements.
  • Presence of parafunctional habits, such as bruxism or other abnormal occlusal habits.

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
Participants will receive preformed BioFlx full-coverage crowns for restoration of eligible primary molars.
Procedure: Preformed BioFlx Crown
Eligible primary molars will be restored with appropriately sized BioFlx crowns following tooth preparation according to the manufacturer's recommendations. The crowns will be adjusted as needed, cemented using glass ionomer cement, and final occlusion will be verified.
Active Comparator: Stainless Steel Crown Group
Participants will receive preformed stainless steel full-coverage crowns for restoration of eligible primary molars.
Procedure: Preformed Stainless Steel Crown
Eligible primary molars will be prepared according to standard clinical procedures, fitted with an appropriately sized crown, adjusted and contoured as required, cemented using glass ionomer cement, and final occlusion will be verified.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occlusal Bite Force Distribution
Time Frame: Baseline (before crown placement), immediately after crown cementation, one and three months after treatment.
The percentage of total occlusal force (%) distributed on the restored primary molar will be measured using a digital occlusal analysis system. The closure demonstrating the maximum recorded occlusal force will be selected for analysis.
Baseline (before crown placement), immediately after crown cementation, one and three months after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Masseter Muscle Activity
Time Frame: Baseline (before crown placement), immediately after crown cementation, one month and three months after treatment.
Bilateral masseter muscle activity, expressed as integrated mean electromyographic activity (µV or µV·s, according to the recording output), will be measured using surface electromyography (sEMG) during the rest position and maximum voluntary clenching.
Baseline (before crown placement), immediately after crown cementation, one month and three months after treatment.
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

Tanta University

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

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)

September 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 23, 2026

First Submitted That Met QC Criteria

August 23, 2026

First Posted (Actual)

August 26, 2026

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #R-PED-7-25-3210

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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