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NCT Number: NCT06900868

The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: A Randomized Clinical Trial

Deep marginal elevation usinge a bioactive dental material in deep subgingival Class II restorations, S-PRG filler-containing materials offer significant benefits due to their bioactive properties, Their ability to release fluoride, remineralization potential and acid neutralization, reducing the risk of recurrent caries, particularly at the gingival margin(Imazato et al. 2023). The antibacterial and antifungal effects help inhibit biofilm formation, enhancing the longevity of restorations. Additionally, these materials support better marginal adaptation by reducing microleakage and improving bond durability (Imazato et al. 2023) This type of composite may improve the outcomes of deep subgingival margin elevation, benefiting both restorative success and periodontal health(Imazato et al. 2023).

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Key information

Conditions

DME Deep Margin Elevation 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: Yes

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
  • No sign of irreversible pulpitis
  • No periapical radiolucency
  • Deep subgingival margin
  • Molars class II with subgingival margin

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

Assigned Interventions

Other

SDR Smart dentine replacement material nonbioactive

Primary outcomes

  1. Recurrent caries

    Time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months

    • 0: no evidence of caries continuous along the margin using periapical radiograph.
    • 1: caries evident continuous with the margin of restoration

Secondary outcomes

  1. Fracture of Restoration

    Time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months

    • 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

  2. Post- operative sensitivity

    Time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months

    • 1: Absent
    • 2: Present

  3. Bleeding on Probing

    Time frame: T0: 1 Week Baseline T1: 6 Months T2: 12 Months

    • 0 :Healthy gums
    • 1 :Bleeding on probing

Study contacts

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

AHMED A Yakop, BDS

CONTACT

[email protected]

00201555134512

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2025
Registry last updated
Mar 28, 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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