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在前上颌骨中使用钛与陶瓷单颗牙种植体:一项为期 12 个月的随机临床试验。

Titanium vs ceramic single dental implants in the anterior maxilla: A 12-month randomized clinical trial.

机构信息

Periodontology Unit, School of Medicine and Dentistry, University of Santiago de Compostela, Santiago de Compostela, Spain.

Odontología Médico-Quirúrgica (OMEQUI) Research Group, Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain.

出版信息

Clin Oral Implants Res. 2021 Aug;32(8):951-961. doi: 10.1111/clr.13788. Epub 2021 Jul 8.

Abstract

OBJECTIVE

The aim of this randomized clinical trial was to compare ceramic and titanium implants with respect to the esthetic and clinical parameters, and patient-reported outcome measures (PROMs).

MATERIAL AND METHODS

Thirty patients received thirty implants (8-12 mm in length, 3.3 mm diameter, and a tissue level design) to replace single teeth in the anterior maxilla. Patients were randomly allocated to receive a ceramic or a titanium implant. Esthetic, clinical parameters, and PROMs were evaluated 18 months after surgery.

RESULTS

At 12 months post-final loading, there were no significant differences between groups with respect to esthetics. Mean Index Crown Aesthetic score was 6.31 (95% C.I. 4.59-8.04) and 6.07 (95% C.I. 4.21-7.93) for ceramic and titanium implants, respectively. The pink esthetic score (PES) was 7.81 (95% C.I. 6.90-8.73) for ceramic implants and 7.86 (95% C.I. 7.11-8.60) for titanium implants, with no significant differences between groups. No statistically significant differences were found for any of the other clinical parameters and PROMs.

CONCLUSIONS

Monotype ceramic implants have proven to be a good treatment option in the upper anterior sector, showing favorable esthetic results, being comparable to titanium implants. This clinical trial has been registered in clinical trials with the identifier CI_RCT_US16 and registration number NCT04707677. A retrospective registration of the clinical trial was carried out since registration was not mandatory on the date the study began.

摘要

目的

本随机临床试验旨在比较陶瓷和钛种植体在美学和临床参数以及患者报告的结果测量(PROMs)方面的差异。

材料和方法

30 名患者接受了 30 个种植体(长度为 8-12mm,直径 3.3mm,为组织水平设计),以替代上颌前牙的单个牙齿。患者被随机分配接受陶瓷或钛种植体。术后 18 个月评估美学、临床参数和 PROMs。

结果

在最终负重后 12 个月,两组在美学方面没有显著差异。陶瓷种植体的平均指数冠美观评分(Index Crown Aesthetic score)为 6.31(95%置信区间 4.59-8.04),钛种植体为 6.07(95%置信区间 4.21-7.93)。陶瓷种植体的粉红色美学评分(pink esthetic score,PES)为 7.81(95%置信区间 6.90-8.73),钛种植体为 7.86(95%置信区间 7.11-8.60),两组之间无显著差异。其他临床参数和 PROMs 也没有发现统计学上的显著差异。

结论

单型陶瓷种植体已被证明是上颌前区的一种良好治疗选择,其美学效果良好,与钛种植体相当。本临床试验已在临床试验中以标识符 CI_RCT_US16 进行注册,注册号为 NCT04707677。由于研究开始时注册不是强制性的,因此对临床试验进行了回顾性注册。

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