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

IF 1.7 Q3 DENTISTRY, ORAL SURGERY & MEDICINE

Clinical and Experimental Dental Research Pub Date : 2024-10-13 DOI:10.1002/cre2.70025

Khattab Mustafa, Ghaith Alfakhry, Hussam Milly

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引用次数: 0

Abstract

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.

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新型 Alkasite 修复材料对非龋性牙颈部病变的牙周评估：随机对照临床试验

目的本研究旨在从菌斑累积、附着丧失和牙龈炎症等方面评估用于治疗非龋性颈椎病（NCCL）的 Cention N（CN）修复体与树脂改性玻璃离子水泥（RM-GIC）修复体的邻近牙周情况。材料和方法这是一项双盲分口三臂随机对照临床试验。研究臂为 RM-GIC（富士二代 LC）、CN + 粘接系统和 CN + 固位槽。每组包括 25 个修复体。在使用修复体后的 1 周、3、6 和 9 个月进行随访。使用牙菌斑指数（PI）、探诊出血指数（BOP）和探诊深度（PD）对牙周状况进行评估。使用适当的检验进行统计分析（α = 0.05）。结果 Cention N 和 RM-GIC 在研究变量方面没有明显差异。然而，在使用修复体后，我们注意到 PI 和 PD 的平均值有所增加。9 个月后，PI 和 PD 的平均值分别增加了 0.06 和 0.34，其中 PD 显著增加。同时还注意到，在 1 周的随访中，所有研究组的 BOP 阳性点的百分比都有所增加，之后在 3 个月和更长时间的随访中，BOP 阳性点的百分比下降到接近干预前的数值。结论 Cention N 和 RM-GIC 这两种离子释放材料在修复 NCCL 时对牙龈组织的效果相当，临床上可以接受。牙龈牵引带和橡胶坝夹对牙周组织的综合影响可能更值得考虑，尤其是与探诊深度有关的影响。今后还需要进行长期研究，评估 Cention N 与非离子释放修复材料相比对龈下生物膜的影响，以及对牙龈炎症的影响。临床试验注册该临床试验已在 clinicaltrial.gov 临床注册中心注册，注册号为 #NCT05593159。

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来源期刊

Clinical and Experimental Dental Research DENTISTRY, ORAL SURGERY & MEDICINE-

CiteScore

3.30

自引率

5.60%

发文量

165

审稿时长

26 weeks

期刊介绍： Clinical and Experimental Dental Research aims to provide open access peer-reviewed publications of high scientific quality representing original clinical, diagnostic or experimental work within all disciplines and fields of oral medicine and dentistry. The scope of Clinical and Experimental Dental Research comprises original research material on the anatomy, physiology and pathology of oro-facial, oro-pharyngeal and maxillofacial tissues, and functions and dysfunctions within the stomatognathic system, and the epidemiology, aetiology, prevention, diagnosis, prognosis and therapy of diseases and conditions that have an effect on the homeostasis of the mouth, jaws, and closely associated structures, as well as the healing and regeneration and the clinical aspects of replacement of hard and soft tissues with biomaterials, and the rehabilitation of stomatognathic functions. Studies that bring new knowledge on how to advance health on the individual or public health levels, including interactions between oral and general health and ill-health are welcome.