Clinical Performance of Bioactive Highly Filled Injectable Flowable Composite for Direct Posterior Occlusal Conservative Restorations Using FDI Criteria: Two Year Randomized Clinical Trial

January 18, 2025 updated by: Mohamed Sherif, Cairo University
The aim of this study is to evaluate Clinical Performance of bioactive highly filled injectable flowable composite for direct posterior occlusal conservative restorations using FDI Criteria

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Early Phase 1

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:The inclusion criteria: patient age range from 16-45 years, with a premolar indicated for extraction, patients required at least a couple of Class I restorations. The patient should have good general health.

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Exclusion Criteria:Where the exclusion criteria will be: poor oral hygiene, sever or chronic periodontal disease or bruxism, severe tooth sensitivity, non-vital or fracture or cracked teeth, defective restorations or bleaching procedures during the last 6 months, pregnancy, and/or lactation, and allergy to the main components of the products to be used in the study.

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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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Other: bioactive highly filled injectable flowable composite
bioactive highly filled injectable flowable composite
Other Names:
  • Shofou Flow Plus X
Active Comparator: Control Group
Other: highly filled injectable flowable composite
highly filled injectable flowable composite
Other Names:
  • GC G-ænial Universal Flo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of caries
Time Frame: 24 Months
Restorations will be assessed for recurrence of caries by visual examination, short air drying
24 Months

Collaborators and Investigators

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

Sponsor

Cairo University

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)

January 20, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 18, 2025

First Submitted That Met QC Criteria

January 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 18, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mohamed Sherif PHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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