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NCT Number: NCT06875544

Clinical Performance of High Viscosity Bioactive Injectable Composite in Deep Marginal Elevation

Using a bioactive resin composite in subgingival Class II cavities can provide enhanced caries resistance by releasing multiple ions, including fluoride. This approach offers greater resistance to caries due to the incorporation of surface pre-reacted glass filler (S-PRG) technology (Imazato, Nakatsuka et al., 2023).

This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health.

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Key information

Conditions

DME Deep Margin Elevation Dental

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult Patient (20-50 years old)
  • Good oral hygiene (plaque index 0 or 1)
  • Patient approval
  • Absence of parafunctional habits and/or bruxism
  • No endodontic treatment
  • No abscess
  • No partial or fixed denture

Exclusion criteria

  • Patients with known allergic or adverse reaction to the tested materials.
  • Bad oral hygiene
  • Systematic disease that may affect participation.
  • Xerostomic patients.
  • Patients with active periodontal disease.
  • Heavy smokers (those who smoke greater than or equal to 25 or more cigarettes a day)
  • Orthodontic treatment patient

Treatment and study plan

Beautifil F00

Other

Beautifil F00 is bioactive giomer resin composite.

G-aenial Universal Injectable Flowable Composite

Other

Nanohybrid resin composite is a type of restorative material that features nano-sized fillers as a main component

Primary outcomes

  1. Recurrent caries

    Time frame: T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months

    • 0: no evidence of caries continuous along the margin
    • 1: caries evident continuous with the margin of restoration

Secondary outcomes

  1. 1. Post-operative sensitivity. 2. Fracture of Restoration. 3. Bleeding on probing

    Time frame: T (Time): T1: 1 week hours Baseline T2: 6 Months T3: 12 Months

    • Post-operative sensitivity.
    • 1: Absent
    • 2: Present
    • Fracture of Restoration.
    • 1: Restoration is intact and fully retained.
    • 2: Restoration is partially retained with some portion of the restoration still intact.
    • 3: Restoration is completely missing
    • Bleeding on probing
    • 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.

Sherif Gamal Hamza, BDS

CONTACT

[email protected]

+201060086406

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Clinical Performance of High Viscosity Bioactive Injectable Composite in Deep Marginal Elevation Randomized Controlled Trail

Acronym: Randomized

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2025
Registry last updated
Mar 13, 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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