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NCT Number: NCT07407855

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Giomer-based composite restoration

Device

Giomer-based composite restoration (Beautifil® II LS, SHOFU, USA) using universal adhesive (BeautiBond® Xtreme, SHOFU, USA).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Radwa Wael Ellahouny

CONTACT

[email protected]

01274268817

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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