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Child and Parental Satisfaction of Bioflx Crowns Compared to Zirconia Crowns in Primary Molars

NCT06897020 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-28

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the child and parents satisfaction 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 child and parents satisfaction levels between BioFlx crowns and 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, occlusal wear, gingival health, as well as preparation time.

Conditions

  • Carious Primary Molars

Interventions

OTHER

(Group A: Bioflx crowns)

prepartion:1.The mesiodistal width of the tooth will be measured using calipers and a closely fitted crown will be selected based on the measurements. 2.The tooth will be prepared similarly to stainless steel crowns (SSCs): • Occlusal reduction of approximately 1-1.5 mm will be done using a diamond bur.Mesial and distal reduction of no more than 1 mm will be performed using a No. 169L diamond bur.Depending on the tooth anatomy, either no buccal and lingual reduction will be needed, or a minimal reduction will be done. 3.All sharp line angles and corners will be smoothed to ensure proper crown fit. 4.The crown will be checked for proper fit before cementation. It will be positioned to extend 1 mm below the gingival margin. 5.The crown will be cemented using luting glass ionomer cement (GIC). The crown will be held with firm, constant pressure until the cement sets initially. 6.The marginal fit will be evaluated, and necessary adjustments will be made. 7.The occlusion will be checked.

OTHER

(Group B: Preformed Zirconia crown

1. Crown Selection: The mesiodistal dimension of the corresponding tooth will be measured . to select the appropriate size. 2. Occlusal Reduction: The marginal ridge of adjacent teeth will be used as a reference point and a 1.5-2 mm of occlusal reduction will be performed to allow proper crown seating. 3. Bucco-Lingual Reduction: The bucco-lingual wall will be reduced by approximately 1-1.5 mm using a flame-shaped diamond bur. 4. Interproximal Reduction: 1mm of interproximal reduction will be performed using a flame-shaped diamond bur such as a .368 or .330tapered carbide bur. 5. Feather Margin Preparation: Subgingival reduction of 1-2 mm will be done using a flame-shaped diamond bur, creating a feathered margin to achieve a passive fit. 6. Trial Fitting of the Crown: The crown will be tried in to ensure proper adaptation. until the crown fits passively and extends sub gingivally by 1-2 mm wit. 7. Glass ionomer cement will be used for cementation.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Prof.Dr. Manal Ahmed Elshiekh, Ph.D · 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
2025-06-01
Primary Completion
2025-12-30
Completion
2026-02-26

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 NCT06897020 on ClinicalTrials.gov