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Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars

NCT06968767 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-05-13

No results posted yet for this study

Summary

This study aims to evaluate and compare the preparation time required for Bioflx crowns versus zirconia crowns on primary molars through a randomized clinical trial.

• Primary Objective: To compare the preparation time required for Bioflex crowns and zirconia crowns on primary molars in pediatric patients.

• Secondary Objectives:

To evaluate the clinical performance of Bioflex crowns compared to zirconia crowns, including:

Retention, Patient Satisfaction, Parental Satisfaction, Occlusal Wear and Gingival Health.

the main question it aim to answer: Is there a significant difference in the preparation time required for Bioflx crowns compared to zirconia crowns in the primary molars of pediatric patients?

Conditions

  • Carious Primary Molars

Interventions

OTHER

bioflx crown

(Group A: Preformed Biofix Crown - Assigned Intervention) 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. 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

zirconia crown

Group B: Preformed Zirconia Crown - Assigned Intervention) 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 one that closely matches the mesiodistal 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 in passively placed fissure bur. Crown Placement \& Passive Fit Check: Place the selected crown on the prepared tooth. 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 seating.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Hala m Alshaeri, Bachelor of Dental surgery · Cairo university faculty of dentistry

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
2025-06-15
Completion
2026-06-16

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 NCT06968767 on ClinicalTrials.gov