Performance of Bioactive Low Viscosity Composite in Deep Marginal Elevation Restorations

March 18, 2025 updated by: Ahmed Mohamed Hossam Elmoaty, Future University in Egypt

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bioactive Giomer Material
Other: Beautiful 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
Active Comparator: Nanohybrid resin composite
Other: Dentsply Nanohybrid flowable composite
a conventional nano hybrid flowable composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent caries
Time Frame: 1 week, 6 months and 12 months
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative sensitivity
Time Frame: 1 week, 6 months and 12 months
  • No: Absent
  • Yes: Present
1 week, 6 months and 12 months
Fracture of the restoration
Time Frame: 1 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
1 week, 6 months and 12 months
Bleeding on probing
Time Frame: 1 week, 6 months and 12 months
  • 0 Healthy gums
  • 1 Bleeding on probing
  • 2 periodontal problem with bone loss
1 week, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 8, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ahmed elmoety protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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