NCT06882343

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 8, 2025

Last Update Submit

March 18, 2025

Conditions

Deep CariesCaries, Dental

Outcome Measures

Primary Outcomes (1)

  • Recurrent caries

    * Yes: no evidence of caries continuous along the margin * No: caries evident continuous with the margin of restoration

    1 week, 6 months and 12 months

Secondary Outcomes (3)

  • Post-operative sensitivity

    1 week, 6 months and 12 months

  • Fracture of the restoration

    1 week, 6 months and 12 months

  • Bleeding on probing

    1 week, 6 months and 12 months

Study Arms (2)

Bioactive Giomer Material

ACTIVE COMPARATOR
Other: Beautiful Flow Plus X

Nanohybrid resin composite

ACTIVE COMPARATOR
Other: Dentsply Nanohybrid flowable composite

Interventions

Beautiful Flow Plus XOTHER

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

Bioactive Giomer Material
Dentsply Nanohybrid flowable compositeOTHER

a conventional nano hybrid flowable composite

Nanohybrid resin composite

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Central Study Contacts

Ahmed Elmoaty, Dentist

CONTACT

+201555717662ahmedelmoety96@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentisy

Study Record Dates

First Submitted

March 8, 2025

First Posted

March 18, 2025

Study Start

April 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

March 21, 2025

Record last verified: 2025-03