Objectives <p>This study evaluates the clinical performance of Cention N (CN), applied with either an adhesive or a retentive groove, in comparison with that of resin-modified glass ionomer cements (RM-GIC) in non-carious cervical lesions (NCCLs).</p> Materials and methods <p>This three-arm, split-unit trial included 81 restorations (<i>n</i> = 27 per group): (1) RM-GIC (Fuji II LC); (2) Cention N with a universal adhesive (CN + UA); and (3) Cention N with a gingival retentive groove without adhesive (CN + RG). Clinical performance was assessed at 6, 12, and 24 months using modified USPHS criteria. Data were analysed using Generalized Estimating Equations (GEE), with Sequential-Bonferroni-adjusted <i>p</i>-values for pairwise comparisons (α = 0.05).</p> Results <p>At 24 months, the recall rate was 77.8%. Retention rates were 100% for CN + UA, 95.2% for RM-GIC, and 61.9% for CN + RG. Significant differences in retention were observed between CN + RG and both CN + UA (<i>p</i> = 0.001) and RM-GIC (<i>p</i> = 0.013). Regarding marginal staining, significant differences emerged between the three groups at the 12- and 24-month intervals (<i>p</i> &lt; 0.05).</p> Conclusions <p>After 24 months of follow-up, CN applied with an adhesive demonstrated clinical performance comparable to RM-GIC. In contrast, CN placed without an adhesive system, despite the use of mechanical retention, exhibited significantly lower restoration retention.</p> Clinical relevance <p>CN is a promising material for restoring NCCLs with high functional clinical performance. CN should be used with an adhesive system in NCCLs, as mechanical retentive features do not compensate for the absence of adhesive bonding.</p> Trial registration <p>This trial was retrospectively registered at clinicaltrials.org, NCT05593159 (12.10.2022). <a href="https://clinicaltrials.gov/study/NCT05593159?cond=Cention%26aggFilters=status:com%20unk%26rank=2">https://clinicaltrials.gov/study/NCT05593159?cond=Cention&amp;aggFilters=status:com%20unk&amp;rank=2</a>.</p>

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Cention N in non-carious cervical lesions: outcomes of a 24-month three-arm randomized controlled trial

  • Khattab Mustafa,
  • Hussam Milly

摘要

Objectives

This study evaluates the clinical performance of Cention N (CN), applied with either an adhesive or a retentive groove, in comparison with that of resin-modified glass ionomer cements (RM-GIC) in non-carious cervical lesions (NCCLs).

Materials and methods

This three-arm, split-unit trial included 81 restorations (n = 27 per group): (1) RM-GIC (Fuji II LC); (2) Cention N with a universal adhesive (CN + UA); and (3) Cention N with a gingival retentive groove without adhesive (CN + RG). Clinical performance was assessed at 6, 12, and 24 months using modified USPHS criteria. Data were analysed using Generalized Estimating Equations (GEE), with Sequential-Bonferroni-adjusted p-values for pairwise comparisons (α = 0.05).

Results

At 24 months, the recall rate was 77.8%. Retention rates were 100% for CN + UA, 95.2% for RM-GIC, and 61.9% for CN + RG. Significant differences in retention were observed between CN + RG and both CN + UA (p = 0.001) and RM-GIC (p = 0.013). Regarding marginal staining, significant differences emerged between the three groups at the 12- and 24-month intervals (p < 0.05).

Conclusions

After 24 months of follow-up, CN applied with an adhesive demonstrated clinical performance comparable to RM-GIC. In contrast, CN placed without an adhesive system, despite the use of mechanical retention, exhibited significantly lower restoration retention.

Clinical relevance

CN is a promising material for restoring NCCLs with high functional clinical performance. CN should be used with an adhesive system in NCCLs, as mechanical retentive features do not compensate for the absence of adhesive bonding.

Trial registration

This trial was retrospectively registered at clinicaltrials.org, NCT05593159 (12.10.2022). https://clinicaltrials.gov/study/NCT05593159?cond=Cention&aggFilters=status:com%20unk&rank=2.