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NCT Number: NCT06721741

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

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

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nusmile bioflex crowns

Other

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

Stainless steel crowns

Other

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 outcomes

  1. Patient relevant criteria

    Time frame: 1 Year

    • Clinically Success if:

    No clinical signs or symptoms like:

    • Pain
    • Dental Abscess/Swelling
    • Sinus Tract/ Fistula
    • Mobility
    • Radiographically Success if:

    No pathology visible on x-ray like:

    • Internal/External Root Resorption
    • Peri-radicular Radiolucency
    • Furcation Involvement
    • Periapical Pathosis

Secondary outcomes

  1. Crown Relevant Criteria

    Time frame: 1Year

    • wear of the opposing Binary (yes or no)

Study contacts

Contact information is provided by the study sponsor or research team.

Hajer Ahmed Mousa

CONTACT

[email protected]

01551106855

Manal Ahmed Elsayed

CONTACT

01227332259

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.