Clinical Performance of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic and Non-Diabetic Patients

February 10, 2026 updated by: Radwa Wael Maher, Cairo University

Comparative Evaluation of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic Versus Non-Diabetic Patients Using Modified USPHS Criteria: An 18-Month Non-Randomized Clinical Trial

Diabetes mellitus is associated with structural and biochemical alterations in dentin that may negatively affect the clinical performance and longevity of adhesive dental restorations, particularly in cervical carious lesions. Giomer-based composite resins, containing pre-reacted glass ionomer fillers, release fluoride and other beneficial ions that may enhance remineralization and reduce the risk of secondary caries.

This prospective, parallel-group, non-randomized clinical trial aims to evaluate the clinical performance of Giomer-based composite restorations in Class V carious lesions in controlled diabetic and non-diabetic patients. Restorations will be assessed using Modified USPHS criteria at baseline, 6, 12, and 18 months, with retention as the primary outcome and marginal adaptation, secondary caries, marginal discoloration, and post-operative sensitivity as secondary outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients with Class V carious lesions (ICDAS scores 3 or 4).
  • Controlled diabetic patients diagnosed with diabetes mellitus (for diabetic group).
  • Non-diabetic patients with no systemic diseases (for control group).
  • Teeth indicated for Class V composite restoration.

Exclusion Criteria:

  • Uncontrolled diabetes mellitus.
  • Patients with other systemic diseases affecting oral health.
  • Teeth with pulpal involvement or requiring endodontic treatment.
  • Patients with parafunctional habits. Pregnant or lactating women

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetic Patients
Controlled diabetic patients with Class V carious lesions restored using Giomer-based composite resin
Device: Giomer-based composite restoration
Giomer-based composite restoration (Beautifil® II LS, SHOFU, USA) using universal adhesive (BeautiBond® Xtreme, SHOFU, USA).
Active Comparator: Non-Diabetic Patients
Non-diabetic patients with Class V carious lesions restored using the same Giomer-based composite and adhesive protocol.
Device: Giomer-based composite restoration
Giomer-based composite restoration (Beautifil® II LS, SHOFU, USA) using universal adhesive (BeautiBond® Xtreme, SHOFU, USA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration Retention Score Assessed Using Modified USPHS Criteria
Time Frame: Baseline, 6 months, 12 months, and 18 months
Retention of Class V Giomer-based composite restorations will be evaluated using Modified United States Public Health Service (USPHS) criteria. Each restoration will be assigned an ordinal score (Alpha, Bravo, Charlie) based on the presence or loss of restoration. Data will be reported as distribution of USPHS scores and frequency of restoration loss over time.
Baseline, 6 months, 12 months, and 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Adaptation Score Assessed Using Modified USPHS Criteria
Time Frame: Baseline, 6 months, 12 months, and 18 months
Marginal integrity between tooth and restoration will be evaluated using Modified USPHS criteria. Each restoration will receive an ordinal score (Alpha, Bravo, Charlie) at each follow-up visit.
Baseline, 6 months, 12 months, and 18 months
Secondary Caries Score Assessed Using Modified USPHS Criteria
Time Frame: Baseline, 6 months, 12 months, 18 months
Presence of recurrent caries adjacent to the restoration will be assessed using Modified USPHS criteria and recorded as ordinal categorical scores (Alpha, Bravo, Charlie).
Baseline, 6 months, 12 months, 18 months
Marginal Discoloration Score Assessed Using Modified USPHS Criteria
Time Frame: Baseline, 6 months, 12 months, 18 months
Discoloration at the tooth-restoration margin will be evaluated using Modified USPHS criteria and recorded as ordinal categorical scores.
Baseline, 6 months, 12 months, 18 months
Post-Operative Sensitivity Score Assessed Using Modified USPHS Criteria
Time Frame: Baseline, 6 months, 12 months, 18 months
Tooth sensitivity associated with restored teeth will be clinically evaluated and scored using Modified USPHS criteria ordinal scores.
Baseline, 6 months, 12 months, 18 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)

August 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU-FD-CD-4-1-3-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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