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Not yet recruiting NCT07575646

Clinical Evaluation of Self-Adhesive Flowable Giomer With and Without Selective Enamel Etching

No phase Interventional Cervical Caries

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: Beautifil Flow Plus F00, FIT SA after selective enamel etching, FIT SA.
Who it may be relevant to
Registry conditions: Cervical Caries. Basic parameters: from 18 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 →

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Official title

18-Month Clinical Evaluation of Self-Adhesive Flowable Giomer With and Without Selective Enamel Etching Versus Flowable Giomer Using Standard Bonding Protocol in Carious Cervical Lesions: A Randomized Clinical Trial

Overview

This randomized clinical trial is to evaluate the clinical performance of the self-adhesive flowable Giomer with and without selective enamel etching compared to flowable Giomer using standard bonding protocol in class V cavity restorations over a period of 18 months.

Detailed description

Self-adhesive flowable restorative materials have been introduced to simplify clinical procedures by eliminating the need for separate bonding steps. These materials are designed to combine adhesive and restorative functions in a single application, which may reduce technique sensitivity and chairside time. However, the bond strength of self-adhesive materials to enamel and dentin remains a concern, particularly in cervical lesions where reliable adhesion is critical for long-term clinical success Selective enamel etching has been suggested as a technique to improve enamel bonding when using self-adhesive or self-etch materials, as it enhances micromechanical retention without adversely affecting dentin bonding. Previous studies have reported that additional enamel etching may improve marginal adaptation and retention, while preserving the simplified clinical procedure of self-adhesive systems. Nevertheless, the clinical effectiveness of self-adhesive Giomer materials with and without selective enamel etching in high caries-risk patients has not been sufficiently investigated.

Therefore, randomized clinical trials evaluating the performance of these materials in cervical carious lesions are required to determine the most reliable restorative approach in patients with increased susceptibility to caries.

Interventions

  • Other Beautifil Flow Plus F00
    Conventional flowable giomer restorative material
  • Other FIT SA after selective enamel etching
    using self-adhesive giomer restorative material after selective enamel etching
  • Other FIT SA
    self-adhesive flowable giomer restorative material

Primary outcome measures

  • Retention [Time frame: 18 Months]
Secondary outcome measures (1)
  • Marginal adaptation, marginal discoloration, secondary caries, and post-operative sensitivity [Time frame: 18 Months]

Eligibility criteria

Inclusion criteria

  • Cervical carious lesions in anterior teeth and premolars
  • Small to moderate class V carious lesion (ICDAS 3 \& 4).
  • Vital upper or lower periodontally sound teeth with no signs of irreversible pulpitis.
  • Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth

Exclusion criteria

  • Cervical carious lesions in molars.
  • Deep carious defects (close to pulp, less than 1 mm distance).
  • Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
  • Non-vital teeth, Fractured or cracked teeth.
  • Endodontically treated teeth.
  • Periodontally affected teeth

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
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07575646 · Self-Adhesive Giomer

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗