Evaluation of Using Self-adhering Flowable Resin Composite in Repairing Old Defective Resin Composite Restorations Over 18 Months Follow up. (A Randomized Clinical Trial)

February 7, 2024 updated by: Soha Sayed Hosny, Cairo University

Evaluation of Using Self-adhering Flowable Resin Composite Versus Conventional Nano-filled Flowable Resin Composite in Repairing Old Defective Resin Composite Restorations Over 18 Months Follow up. (A Randomized Clinical Trial)

This research proposal is evaluating the clinical performance of using self-adhering flowable resin composite in repairing old occlusal defective resin composite versus conventional flowable resin composite restoration over 18 months.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

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 Locations

  • Egypt
      • Cairo, Egypt, 113311
        • Faculty of Dentistry

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:

  • Patients (18-35 y)
  • patients with defective resin composite class I restorations that need repair.
  • dental motivated patients who attends regularly.
  • Vital posterior teeth with repairable defective resin composite class I restorations.
  • Localized marginal defect or marginal staining FDI 3& 4.
  • Teeth with no or minimum mobility & healthy peridontium.
  • No history of any irreversible pulpal pain or necrosis in the teeth to be restored.

Exclusion Criteria:

  • • Patients with defective restorations that dictate replacement

    • Uncooperative behavior limits the isolation techniques throughout the procedure.
    • Presence of parafunctional habits.
    • Patient with history of systemic medical disease, or any other serious relevant problem.
    • High caries risk patients. Periodontal disease that may affect the prognosis of the restoration or the tooth itself.
    • Fractured or visibly cracked teeth.
    • Symptoms of any pulp pathosis.
    • Defective resin composite restorations that dictate replacement.

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: Conventional flowable nano filled resin composite
Repairing the old defective class I composite restoration by conventional nano filled flowable resin composite.
Procedure: VertiseTM flowable composite (Kerr,USA)
self adhesive flowable resin composite restoration.
Experimental: Self adhesive flowable resin composite
Repairing the old defective class I composite restoration by self adhering flowable resin composite.
Procedure: VertiseTM flowable composite (Kerr,USA)
self adhesive flowable resin composite restoration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration clinical performance using FDI criteria
Time Frame: assessment will be done after the treatment then 6 months, 12 months and18 months.
FDI criteria mechanical parameters
assessment will be done after the treatment then 6 months, 12 months and18 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 (Actual)

February 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Repairing defective composite

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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