Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06900868
Enrollment
50
Registered
2025-03-28
Start date
2025-03-20
Completion date
2026-04-20
Last updated
2025-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Margin Elevation, Dental, Dental Caries, DME

Keywords

Deep margin elevation

Brief summary

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).

Interventions

OTHERAssigned Interventions

SDR Smart dentine replacement material nonbioactive

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrent cariesT0: 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

MeasureTime frameDescription
Fracture of RestorationT0: 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
Post- operative sensitivityT0: 1 Week Baseline T1: 6 Months T2: 12 Months* 1: Absent * 2: Present
Bleeding on ProbingT0: 1 Week Baseline T1: 6 Months T2: 12 Months* 0 :Healthy gums * 1 :Bleeding on probing

Contacts

Primary ContactAHMED A Yakop, BDS
Ahmed.yakop66@Gmail.com00201555134512

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026