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NCT Number: NCT06882343

Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations

The goal of this study is to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer Shofu Flow Plus X F03 compared to nanohybrid resin composite restoration in deep subgingival proximal cavities over a period of 12 months.

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Key information

Conditions

Deep Caries Caries, Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults patients (20-50)
  • Good oral hygiene (plaque index 0 or 1 )
  • Patient approving to participate in the study
  • Absence of parafunctional habits and/or bruxism

Exclusion criteria

  • Patients with known allergic or adverse reaction to the tested materials.
  • Systematic disease that may affect participation.
  • Xerostomic patients.
  • Bad oral hygiene (plaque index 2 or 3 )
  • Heavy smokers
  • Patients undergoing or will start orthodontic treatment
  • Patients with removable prothesis

Treatment and study plan

Beautiful Flow Plus X

Other

Shofu's Beautifil Flow Plus X F03 is an advanced injectable bioactive composite that merges the adaptability of flowable composites with the mechanical properties of hybrid composites

Dentsply Nanohybrid flowable composite

Other

a conventional nano hybrid flowable composite

Primary outcomes

  1. Recurrent caries

    Time frame: 1 week, 6 months and 12 months

    • Yes: no evidence of caries continuous along the margin
    • No: caries evident continuous with the margin of restoration

Secondary outcomes

  1. Post-operative sensitivity

    Time frame: 1 week, 6 months and 12 months

    • No: Absent
    • Yes: Present

  2. Fracture of the restoration

    Time frame: 1 week, 6 months and 12 months

    • Restoration is intact and fully retained.
    • Restoration is partially retained with some portion of the restoration still intact.
    • Restoration is completely missing

  3. Bleeding on probing

    Time frame: 1 week, 6 months and 12 months

    • 0 Healthy gums
    • 1 Bleeding on probing
    • 2 periodontal problem with bone loss

Study contacts

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

Ahmed Elmoaty, Dentist

CONTACT

[email protected]

+201555717662

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations: a Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2025
Registry last updated
Mar 21, 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.

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