An interventional study of Beautifil Flow Plus F00 and FIT SA after selective enamel etching in Cervical Caries, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's planned enrollment of 75 is above the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Conventional flowable giomer restorative material with standard bonding protocol
Other: Beautifil Flow Plus F00
Self-adhesive flowable giomer restorative material
Other: FIT SA
Self-adhesive flowable giomer restorative material after selective enamel etching
Other: FIT SA after selective enamel etching
Conventional flowable giomer restorative material
using self-adhesive giomer restorative material after selective enamel etching
self-adhesive flowable giomer restorative material
Retention
Modified USPHS criteria
Time frame: 18 Months
Marginal adaptation, marginal discoloration, secondary caries, and post-operative sensitivity
Modified USPHS criteria
Time frame: 18 Months
No study locations are listed for this record.
Plan to share: Yes — 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
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jan 2028, 18 months later.
Of 21 interventional studies with no phase under Root Caries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 18 months is below that.
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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