Bite Force Recovery Following Pediatric Full Crown Restorations

NCT07786805 | Not Yet Recruiting DMC

• 1 other identifier: #R-PED-7-25-3210
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bite Force; Stainless-steel Crown; Masseter Muscle

Keywords

bite force, dental caries, restoration, Bioflx crown, Stainless steel crowns

Outcome Measures

Primary Outcomes (1)

• Occlusal Bite Force Distribution

  cclusal force distribution will be assessed using digital occlusal analysis. The percentage of the total occlusal force occurring on the restored primary molar will be recorded. 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 Outcomes (2)

• Masseter Muscle Activity

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

• Occlusal Contacts

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

Study Arms (2)

BioFlx Crown Group

EXPERIMENTAL

Participants will receive preformed BioFlx full-coverage crowns for restoration of eligible primary molars.

Procedure: Preformed BioFlx Crown

Stainless Steel Crown Group

ACTIVE COMPARATOR

Participants will receive preformed stainless steel full-coverage crowns for restoration of eligible primary molars.

Procedure: Preformed Stainless Steel Crown

Interventions

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.

BioFlx Crown Group

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.

Stainless Steel Crown Group

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

faculty of dentistry, Tanta university

Tanta, Cairo Governorate, 31527, Egypt

Location

Related Publications (2)

• Aishwarya N, Nagarathna C, Poovani S, Thumati P. Comparison of Bite Force and the Influencing Factors Pre- and Post-cementation of Stainless Steel Crown in Children Using T-Scan. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):46-50. doi: 10.5005/jp-journals-10005-1900.

  PMID: 34326583 BACKGROUND

• Owais AI, Al-Battah AH, Abu Alhaija ES. Changes in occlusal bite force following placement of preformed metal crowns on primary molars in 4-6 years old children: a 6 months' follow-up pilot study. Eur Arch Paediatr Dent. 2019 Feb;20(1):9-14. doi: 10.1007/s40368-018-0370-8. Epub 2018 Nov 20.

  PMID: 30460643 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

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

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

EG (1)