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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beautifil Flow Plus F00 | Active Comparator | Conventional flowable giomer restorative material with standard bonding protocol |
|
| FIT SA | Experimental | Self-adhesive flowable giomer restorative material |
|
| FIT SA after selective enamel etching | Experimental | Self-adhesive flowable giomer restorative material after selective enamel etching |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beautifil Flow Plus F00 | Other | Conventional flowable giomer restorative material |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Modified USPHS criteria | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Marginal adaptation, marginal discoloration, secondary caries, and post-operative sensitivity | Modified USPHS criteria | 18 Months |
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Inclusion Criteria:
Exclusion Criteria:
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There is no available evidence for assessing FIT SA restorative material in restoration of cervical lesions. Therefore, this study aims to provide valuable insights into the shear bond strength and clinical performance, in terms of the biological, mechanical and esthetic parameters, of FIT SA restorative material in restoration of cervical lesions
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| ID | Term |
|---|---|
| D017213 | Root Caries |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C000621145 | Beautifil Flow Plus F00 |
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| FIT SA after selective enamel etching | Other | using self-adhesive giomer restorative material after selective enamel etching |
|
| FIT SA | Other | self-adhesive flowable giomer restorative material |
|