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Not yet recruiting NCT06895707

Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars

No phase Interventional Clincal Evaluation of BioFlx Vs. Zirconia Crowns

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BioFlx crown, Zirconia crown.
Who it may be relevant to
Registry conditions: Clincal Evaluation of BioFlx Vs. Zirconia Crowns. Basic parameters: 5 years — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Evaluation of BioFlx Crowns and Preformed Zirconia Crowns on Primary Second Molars: a Randomized Clinical Trial

Overview

The goal of this clinical trial is to clinically evaluate the performance of BioFlx in comparison to preformed zirconia crowns in the restoration of primary second molars in pediatric patients. The main questions it aims to answer are: Is there a difference between BioFlx crowns (Group A) and one zirconia (Group B) in terms of crown retention (primary outcome)? Is there a difference between BioFlx crowns (Group A) and one zirconia (Group B) in modified gingival index, plaque index, occlusion, surface roughness, stain resistance, wear of opposing tooth, color match, anatomic form, marginal integrity and discoloration, proximal contact, and recurrent caries at the crown margins? Researchers will compare the clinical performance of Bioflx crowns and zirconia crowns to determine if they are similar. Participants: * Participants will be asked to attend two appointments. During the first visit, a BioFlx crown will be placed on the primary lower second molar, and during the second visit, a zirconia crown will be placed on the contralateral primary lower second molar. * Participants will be recalled and evaluated after 3, 6, and 12 months.

Interventions

  • Other BioFlx crown
    NuSmile® BioFlx crown (Group A) will be placed on primary lower second molar.
  • Other Zirconia crown
    Zirconia crown (Group B) will be placed on the contralateral primary lower second molar.

Primary outcome measures

  • Crown retention [Time frame: 3, 6, 12 months]
Secondary outcome measures (11)
  • Modified gingival index [Time frame: 3, 6, 12 months]
  • Plaque index [Time frame: 3, 6, 12 months]
  • Occlusion [Time frame: 3, 6, 12 months]
  • Surface roughness [Time frame: 3, 6, 12 months]
  • Stain resistance [Time frame: 3, 6, 12 months]
  • Wear of opposing tooth [Time frame: 3, 6, 12 months]
  • Color match [Time frame: 3, 6, 12 months]
  • Anatomic form [Time frame: 3, 6, 12 months]
  • Marginal integrity and discoloration [Time frame: 3, 6, 12 months]
  • Proximal contact [Time frame: 3, 6, 12 months]
  • Recurrent caries [Time frame: 3, 6, 12 months]

Eligibility criteria

Inclusion criteria

  • Children aged 5-9 years old.
  • American Society of Anesthesiologists Classification I or II status.
  • Cooperative child.
  • Obtained informed consent.
  • Two primary lower second molars requiring full coverage restorations.
  • Primary lower second molars in functional occlusion with the opposing tooth and have at least one contact area with an adjacent tooth.
  • Primary lower second molars that can be adequately isolated.
  • Pulptomized primary lower second molars.
  • Primary lower second molars with multi-surface caries.

Exclusion criteria

  • American Society of Anesthesiologists Classification higher or equal to three statuses.
  • Informed consent is not obtained.
  • Allergy to local anesthesia.
  • Non-restorable primary lower second molars.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06895707 · FPGRP/2024/822/1146/1065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗