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Not yet recruiting NCT07731308

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

No phase Interventional Class V Dental Caries, Type 2 Diabetes Mellitus Giomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zirconomer, Beautifil Flow Plus X.
Who it may be relevant to
Registry conditions: Class V Dental Caries, Type 2 Diabetes Mellitus, Giomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer. Basic parameters: 22 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Other Zirconomer
    Zirconia-reinforced glass ionomer restorative material (SHOFU)
  • Other Beautifil Flow Plus X
    Injectable giomer restorative material incorporating S-PRG technology (SHOFU)

Primary outcome measures

  • Restoration Retention [Time frame: Baseline, 6 months, 12 months, and 18 months]
Secondary outcome measures (4)
  • Marginal adaptation [Time frame: Baseline, 6 months, 12 months, and 18 months]
  • Marginal discoloration [Time frame: Baseline, 6 months, 12 months and 18 months]
  • Secondary caries [Time frame: Baseline, 6 months, 12 months and 18 months.]
  • Postoperative sensitivity [Time frame: Baseline, 6 months, 12 months and 18 months.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07731308 · Cons 3-7-5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗