Three-Year Clinical Performance of Fiber-reinforced Versus Indirect Resin Composite Posterior Restorations

May 8, 2025 updated by: Mansoura University
This study aimed to perform a comparison between the clinical performance of short fiber-reinforced composite and indirect lab composite restorations in posterior dentition.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

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
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Mansoura University

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:

  1. Patients aged 20-35 year from both genders.
  2. Good oral hygiene: patients with low and moderate caries risk (according to Caries management by caries risk assessment CAMBRA sheets) were enrolled in this study.
  3. The visual examination should reveal the presence of a minimum of three primary occlusal or proximal caries (Black Class I and II) with a severity score of 4 or 5 according to the International Caries Detection and Assessment System (ICDAS).
  4. The carious teeth must exhibit vitality and do not display periapical radiolucency as evaluated by periapical radiography.
  5. The selected teeth must be under stable occlusion.

Exclusion Criteria:

  1. Uncontrolled systemic disease
  2. Extremely poor oral hygiene
  3. Chronic periodontitis
  4. Heavy bruxism
  5. Cavities with a buccolingual width exceeding two-thirds of the intercuspal distance or requiring cusp covering.
  6. Patients undergoing orthodontic procedures.
  7. Patients unable to attend the scheduled recall appointments.

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: Fiber-reinforced composite
Other: indirect lab composite
indirect lab processed resin composite inlay restorations
Other: Conventional resin composite
conventional microhybrid resin composite posterior restorations
Active Comparator: Indirect lab composite
Other: Conventional resin composite
conventional microhybrid resin composite posterior restorations
Other: Fiber-reinforced composite
short fiber-reinforced composite used as base covered by conventional composite
Active Comparator: Conventional microhybrid resin composite
Other: indirect lab composite
indirect lab processed resin composite inlay restorations
Other: Fiber-reinforced composite
short fiber-reinforced composite used as base covered by conventional composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FDI criteria for evaluation
Time Frame: Three years follow-up
Three years follow-up

Collaborators and Investigators

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

Sponsor

Mansoura 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)

January 1, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 31, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A02071221

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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