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Occlusal Wear Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars

NCT06890949 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-24

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the occlusal wear of Bioflx crowns compared to zirconia crowns in the restoration of primary molars.

The main question\[s\] it aims to answer : " Is there a difference in the occlusal wear of BioFlx crowns compared to zirconia crowns in the restoration of primary molars?" The study will also assess the clinical performance of both types of crowns in terms of retention,gingival health, preparation time, as well as child and parental satisfaction.

Conditions

  • Carious Primary Molars

Interventions

OTHER

(Group A: Preformed Bioflx Crown)

Crown Selection \& Tooth Preparation Measure the mesiodistal width using calipers to select an appropriately sized crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the crown that closely matches the measured mesiodistal width. Select the smallest crown that preserves proximal contacts using a trial-and-error approach. if crimping is necessary use Howe's pliers. Tooth Preparation Perform 1-1.5 mm occlusal reduction using a tapered diamond bur. Reduce proximal areas by approximately 0.5 mm to clear the contact area. Crown Placement \& Cementation Ensure a snug fit of the selected crown. Apply a thin layer of glass ionomer cement inside the crown. Seat the crown firmly using finger pressure. Have the child bite down gently to ensure proper seating. Final Adjustments \& Cleanup Remove excess cement with floss or an explorer. Verify the crown's fit, occlusion, and stability.

OTHER

(Group B: Preformed Zirconia crown)

Crown Selection Measure the mesiodistal width using calipers to select the appropriate crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the crown that closely matches the measured width. Select the smallest crown that preserves proximal contacts. Tooth Preparation Reduce the occlusal surface by 1.5-2 mm using a tapered diamond bur. Reduce interproximal areas by 1-1.5 mm, ensuring a feather-edge finish. Perform a 1-2 mm subgingival preparation using a tapered fissure bur. Crown Placement \& Passive Fit Check Place the selected crown and check for passive fit. Cementation of the Crown Apply a thin layer of glass ionomer cement inside the crown. Seat the crown with passive finger pressure. Have the child bite down gently to ensure proper seating. Final Adjustments \& Cleanup Remove excess cement using floss or an explorer. Verify fit, occlusion, and stability

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Manal Ahmed Elshiekh, prof, PhD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2026-06-15
Completion
2026-07-16

Countries

  • Egypt

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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 NCT06890949 on ClinicalTrials.gov