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NCT Number: NCT07731308

Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations

This randomized controlled clinical trial aims to compare the clinical performance of zirconia-reinforced glass ionomer and injectable giomer restorations in Class V carious lesions among controlled type II diabetic against non-diabetics. One hundred Class V restorations will be allocated equally into four parallel groups according to restorative material and diabetic status. Clinical performance will be evaluated at baseline, 6, 12, and 18 months using the modified United States Public Health Service (USPHS) criteria. The primary outcome is restoration retention, while secondary outcomes include marginal adaptation, marginal discoloration, secondary caries, and postoperative sensitivity.

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Key information

Conditions

Class V Dental Caries, Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Giomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

22 year–55 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

  • Male or Female participants from 22 to 55 years
  • Controlled diabetic and non-diabetic patients consulting the outpatient clinic
  • Patients categorized as moderate or high caries risk
  • Patients willing to provide informed consent
  • Co-operative patients agreeing to participate in the trial Inclusion Criteria for teeth
  • Teeth with class V carious lesion classified according to the International Caries Detection and Assessment System (ICDAS II) as ICDAS code (4) or ICDAS code (5)
  • Teeth with normal pulp vitality testing; no signs of inflammation or spontaneous pain before treatment

Exclusion criteria

  • Patients with spontaneous or elicited pain from caries.
  • Systemic illnesses other than diabetes.
  • Severe bruxism/clenching.
  • Temporomandibular joint disorders.
  • Inability to return for recall visits/ Refusal to participate in the study.
  • Pregnancy.
  • heavy smoking.
  • Lack of compliance.

Exclusion criteria

for teeth

  • Teeth presenting with spontaneous or elicited pain
  • A lack of normal pulp vitality testing
  • Visible or clinical signs of pulpal/periapical inflammation before treatment.
  • Class V carious lesions that are not classified as ICDAS code (4) or ICDAS code (5).

Treatment and study plan

zirconomer

Other

Zirconia-reinforced glass ionomer restorative material (SHOFU)

Beautifil Flow Plus X

Other

Injectable giomer restorative material incorporating S-PRG technology (SHOFU)

Primary outcomes

  1. Restoration Retention

    Time frame: Baseline, 6 months, 12 months, and 18 months

    Restoration retention assessed using the modified USPHS criteria

Secondary outcomes

  1. Marginal adaptation

    Time frame: Baseline, 6 months, 12 months, and 18 months

    Using Modified USPHS Criteria

  2. Marginal discoloration

    Time frame: Baseline, 6 months, 12 months and 18 months

    Using Modified USPHS Criteria

  3. Secondary caries

    Time frame: Baseline, 6 months, 12 months and 18 months.

    Using Modified USPHS Criteria

  4. Postoperative sensitivity

    Time frame: Baseline, 6 months, 12 months and 18 months.

    Using Modified USPHS Criteria

Study contacts

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

Mohamed Ayman Hamdy Ayman

CONTACT

[email protected]

+201127669997

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Performance of Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations of Diabetic and Non Diabetic Patients: 18 Months Controlled Clinical Trial

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Jul 28, 2026
Registry last updated
Jul 28, 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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