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Vertical Dimension Changes After Bioflx vs Stainless Steel Crowns in Primary Molars

NCT07523776 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-13

No results posted yet for this study

Summary

this randomized controlled trial will compare Bioflx crowns and stainless-steel crowns in children with pulp-treated primary molars. The study will evaluate changes in vertical dimension and mean biting force after crown placement and will also assess parental satisfaction with esthetics and treatment impact. Eligible children aged 6 to 9 years will be randomly assigned in a 1:1 ratio to receive either a Bioflx crown or a stainless-steel crown. Measurements will be taken at baseline, immediately after crown placement, at 1 week, and at 4 weeks.

Conditions

  • Early Childhood Caries
  • Dental Caries
  • Pulp-Treated Primary Molars

Interventions

DEVICE

Bioflx Crown

Aesthetic full-coverage pediatric crown used after pulp therapy of primary molars. The Bioflx crown will be selected according to tooth size, adapted following the study protocol, and cemented with resin-modified glass ionomer cement.

DEVICE

Stainless Steel Crown

Preformed stainless steel full-coverage pediatric crown used after pulp therapy of primary molars. The stainless steel crown will be selected according to tooth size, adapted following the study protocol, and cemented with resin-modified glass ionomer cement

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Osama A El shahawy, PHD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07523776 on ClinicalTrials.gov