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

F

Future University in Egypt

Status

Not yet enrolling

Conditions

Dental
Dental Caries
Deep Margin Elevation
DME

Treatments

Other: Assigned Interventions

Study type

Interventional

Funder types

Other

Identifiers

NCT06900868
Deep marginal elevation

Details and patient eligibility

About

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).

Enrollment

50 estimated patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

arm
Active Comparator group
Description:
Beautifil-Bulk Flowable Deep margin elevation and subsequent restoration will be done using bioactive goimer material
Treatment:
Other: Assigned Interventions

Trial contacts and locations

0

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Central trial contact

AHMED A Yakop, BDS

Data sourced from clinicaltrials.gov

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