Periodontal Evaluation for a New Alkasite Restorative Material in Noncarious Cervical Lesions: A Randomized-Controlled Clinical Trial.

OBJECTIVES

This study aims to evaluate the periodontal condition adjacent to Cention N (CN) restorations applied for noncarious cervical lesions (NCCL) compared with resin-modified glass ionomer cement (RM-GIC) restorations in terms of plaque accumulation, attachment loss, and gingival inflammation.

MATERIALS AND METHODS

This is a double-blind split-mouth three-armed randomized-controlled clinical trial. The study arms are RM-GIC (FUJI II LC), CN + adhesive system, and CN + retentive groove. The study included 25 restorations per arm. Follow-ups were performed at 1 week, 3, 6, and 9 months after the application of the restorations. The periodontal condition was evaluated using the plaque index (PI), the bleeding on probing index (BOP), and the probing depth (PD). Appropriate tests were used to perform statistical analyses (α = 0.05).

RESULTS

There was no significant difference between Cention N and RM-GIC regarding the studied variables. However, after the application of the restorations, it was noted that the PI and the PD mean values increased. The average increase after 9 months was 0.06 and 0.34 for PI and PD, respectively, with that of PD being significant. It was also noted that the percentage of positive BOP sites increased at the 1-week follow-up for all study groups and afterward dropped to near preintervention values at the 3-month and later follow-ups.

CONCLUSIONS

The two ion-releasing materials Cention N and RM-GIC have a comparable and clinically acceptable effect on the gingival tissue when restoring NCCLs. The combined effect of the gingival retraction cord and the rubber dam clamp on the periodontal tissues might be more important to consider, especially in relation to the probing depth. Future long-term studies are needed to evaluate the effect of Cention N on the subgingival biofilm in comparison with nonion-releasing restorative materials, and subsequently, its effect on gingival inflammation.

CLINICAL TRIAL REGISTRATION

This clinical trial was registered in clinicaltrial.gov clinical registry under protocol #NCT05593159.