Aesthetic Performance of Two Injectable Resin Composites in Class V Cavities: A Randomized Clinical Trial

June 15, 2025 updated by: Abdelrhman Elhariry, Future University in Egypt
Using bioactive injectable resin composite in anterior class v carious lesions can provide better aesthetic outcome and marginal integrity by releasing multiple ions, including fluoride. This offers better marginal integrity due to presence of S-PRG fillers

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

Yes

Description

Inclusion Criteria:

  1. Age 20-60 years.
  2. Co-operative participants approving to participate in the study.
  3. Male or female patients.
  4. Medically free participants.
  5. Moderate or high caries risk participants.

Exclusion Criteria:

  1. Systemic disease or severe medical complications.
  2. Participants with a history of allergy to any component of restorations will be used in the study.
  3. Lack of compliance
  4. Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre habits

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Beautifil flow plus x f00
Bioactive giomer based injectable resin composite
Procedure: Giomer based injectable composite
Giomers utilize surface pre-reacted glass (SPRG) technology, which involves an acid-base reaction between fluorine-containing glass particles and polymer-containing acid when exposed to water. This reaction results in the formation of a glass ionomer phase, which is then dispersed throughout the resin. Furthermore, the S-PRG fillers present in giomer materials enable the continuous release and replenishment of fluoride, offering long-lasting protection against the recurrence of caries
Active Comparator: G-aenial universal injectable resin composite
conventional injectable resin composite
Procedure: Universal injectable resin composite
Conventional injectable resin composite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Marginal discoloration using FDI criteria
Time Frame: 12 Month
12 Month

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)

June 10, 2025

Primary Completion (Estimated)

April 13, 2026

Study Completion (Estimated)

April 13, 2026

Study Registration Dates

First Submitted

April 12, 2025

First Submitted That Met QC Criteria

April 27, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 15, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • class v restoration

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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