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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorFuture University in Egypt

About this 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

• 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 )

Trial design

Design model

Single group

Treatments tested in this trial

  • Assigned Interventions

    Other intervention

    SDR Smart dentine replacement material nonbioactive

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recurrent caries

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

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

Secondary outcomes

1

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

Time frame
T0: 1 Week Baseline T1: 6 Months T2: 12 Months
2

Post- operative sensitivity

* 1: Absent * 2: Present

Time frame
T0: 1 Week Baseline T1: 6 Months T2: 12 Months
3

Bleeding on Probing

* 0 :Healthy gums * 1 :Bleeding on probing

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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