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Not yet recruiting NCT06721741

Clinical and Radiographic Success of Nusmile Bioflex Versus Stainless-Steel Crowns in Restoring Decayed Primary Molars with Modified Hall Technique

No phase Interventional Restoration of Primary Molars with Bioflex 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: Nusmile bioflex crowns, Stainless steel crowns.
Who it may be relevant to
Registry conditions: Restoration of Primary Molars with Bioflex Crowns. Basic parameters: 4 years — 7 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 →
Official title

Clinical and Radiographic Success of Nusmile Bioflex Versus Stainless-Steel Crowns in Restoring Decayed Primary Molars with Modified Hall Technique:A Randomized Clinical Study

Overview

This pilot study aims to compare the clinical and radiographic success of Bioflex (Nusmile) crowns Versus Stainless-steel crowns in restoring decayed primary molars.

Detailed description

Decayed primary teeth must be treated promptly because they are crucial for chewing, speaking, and holding the space for permanent teeth. Losing primary teeth too early can cause various issues, including psychological problems. Hence, restoring decayed primary teeth is an essential aspect of pediatric dentistry Preformed metal crowns are a popular and affordable option as a treatment for dental caries. They offer full crown coverage and help to prevent recurrent caries. However, their aesthetic limitation is a notable drawback Parents are increasingly concerned about the appearance of dental restorations for their children and prefer tooth-colored options. To overcome this issue, Nusmile has introduced a new type of crown called "Bioflex". These crowns combine the best qualities of both stainless steel and zirconia crowns, as they are flexible, adaptable, and durable

Interventions

  • Other Nusmile bioflex crowns
    The Bioflex crown is a new synthetic crown that has been introduced in pediatric practice. This crown is believed to offer better adaptation, durability, and ease of handling, along with improved aesthetic properties when compared to conventional crowns
  • Other Stainless steel crowns
    Preformed metal crowns are a popular and affordable option as a treatment for dental caries. They offer full crown coverage and help to prevent recurrent caries. However, their aesthetic limitation is a notable drawback

Primary outcome measures

  • Patient relevant criteria [Time frame: 1 Year]
Secondary outcome measures (1)
  • Crown Relevant Criteria [Time frame: 1Year]

Eligibility criteria

Inclusion criteria

  • Clinical Criteria:
  • Children from age 4-7.
  • Cooperative children and willing for follow-up visits.
  • Mandibular second Primary molars with multi-surface caries
  • Radiographic criteria:
  • Mandibular second Primary molars with at least two-thirds of the root remaining.

Exclusion criteria

  • • General Criteria:

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  • •Unable to attend follow-up visits
  • •Refuse to participate in the study
  • •Uncooperative child
  • Clinical Criteria:
  • • Tooth with grade II or grade III mobility
  • •Children with bruxism
  • • Pulpally involved teeth
  • Radiographic Criteria:
  • •Tooth with pathological root resorption
  • •Teeth with root caries

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
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06721741 · Bioflex crowns

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗