Clinical Performance of Different Ion-Releasing Restorative Systems in Class II Cavities (ION-REST II)

July 7, 2026 updated by: Mansoura University

Two-Year Clinical Performance of Different Ion-Releasing Restorative Systems Applied in Class II Cavities

Different ion-releasing restorative systems will be applied in class II cavities then their clinical performance will be evaluated and compared

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized clinical trial aims to evaluate the clinical performance of different ion-releasing restorative systems used in Class II posterior cavities over a two-year follow-up. Patients must be in adults (not less than 18 years old), able to attend regular follow-up visits, presenting with at least four carious class II posterior teeth requiring restoration. Pregnant patients will be excluded.

Study Type

Interventional

Enrollment (Actual)

40

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 Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35516
        • Faculty of Dentistry, 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

Yes

Description

Inclusion Criteria:

  • at least 4 carious posterior teeth

Exclusion Criteria:

  • pregnancy - not able to attend for regular follow-up -smokers or very bad oral hygiene

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
Experimental: conventional bulk fill restorative system
posterior cavities restored with conventional bulk fill restorative system applied in single increment according to the manufacturer's instructions
Procedure: conventional bulk fill restorative system
conventional bulk fill restorative system used for posterior applications
Experimental: ion- releasing restorative system 1
posterior cavities restored with ion-releasing restorative system applied 1 in single increment according to the manufacturer's instructions
Procedure: ion-releasing restorative system 1
ion-releasing restorative system 1 used for posterior applications
Experimental: ion-releasing restorative system 2
posterior cavities restored with ion-releasing restorative system 2 applied in single increment according to the manufacturer's instructions
Procedure: ion-releasing restorative system 2
ion-releasing restorative system 2 used for posterior applications
Experimental: ion-releasing restorative system 3
posterior cavities restored with ion-releasing restorative system 3 applied in single increment according to the manufacturer's instructions
Procedure: ion-releasing restorative system 3
ion-releasing restorative system 3 used for posterior applications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference between baseline and after two years of evaluation
Time Frame: baseline to two-years
Changes in restoration performance according to the modified Federation Dentaire Internationale (FDI) criteria from baseline to 2 years. Scores range from 1 to 5, where lower scores indicate better clinical performance and higher scores indicate poorer clinical performance.
baseline to two-years

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Asmaa A Elbanna, Assistant Lecturer, Faculty of Dentistry, 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)

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDP.25.04.11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol and statistical analysis will be shared to other researchers

IPD Sharing Time Frame

Data will be available after two years

IPD Sharing Access Criteria

anyone

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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