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Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations

Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations: a Randomized Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06882343
Enrollment
50
Registered
2025-03-18
Start date
2025-04-01
Completion date
2026-04-01
Last updated
2025-03-21

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

Conditions

Caries, Dental, Deep Caries

Brief summary

The goal of this study is to evaluate the clinical, radiographic and periodontal performance of bioactive Giomer Shofu Flow Plus X F03 compared to nanohybrid resin composite restoration in deep subgingival proximal cavities over a period of 12 months.

Interventions

OTHERBeautiful Flow Plus X

Shofu's Beautifil Flow Plus X F03 is an advanced injectable bioactive composite that merges the adaptability of flowable composites with the mechanical properties of hybrid composites

OTHERDentsply Nanohybrid flowable composite

a conventional nano hybrid flowable composite

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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

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 caries1 week, 6 months and 12 months* Yes: no evidence of caries continuous along the margin * No: caries evident continuous with the margin of restoration

Secondary

MeasureTime frameDescription
Post-operative sensitivity1 week, 6 months and 12 months* No: Absent * Yes: Present
Fracture of the restoration1 week, 6 months and 12 months* Restoration is intact and fully retained. * Restoration is partially retained with some portion of the restoration still intact. * Restoration is completely missing
Bleeding on probing1 week, 6 months and 12 months* 0 Healthy gums * 1 Bleeding on probing * 2 periodontal problem with bone loss

Contacts

Primary ContactAhmed Elmoaty, Dentist
ahmedelmoety96@gmail.com+201555717662

Outcome results

None listed

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