Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07786805

Bite Force Recovery Following Pediatric Full Crown Restorations

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

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry, Tanta university

Tanta, Cairo Governorate, 31527, Egypt

Location contact

shaimaa eldesouky

CONTACT

[email protected]

01008994242

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Preformed BioFlx Crown

Procedure

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.

Preformed Stainless Steel Crown

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 31, 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.

Published trials that share one or more normalized conditions with this study.