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一项关于双单位外展悬臂式或三单位固定可动树脂粘结式固定局部义齿修复缺失磨牙的随机对照临床试验。

A randomised controlled trial of two-unit cantilevered or three-unit fixed-movable resin-bonded fixed partial dentures replacing missing molars.

机构信息

Faculty of Dentistry, The University of Hong Kong, Hong Kong.

Faculty of Dentistry, The University of Hong Kong, Hong Kong.

出版信息

J Dent. 2020 Dec;103:103519. doi: 10.1016/j.jdent.2020.103519. Epub 2020 Nov 2.

Abstract

OBJECTIVE

To examine the short-term clinical performance and patient-reported outcomes of two-unit cantilevered (CL2) and three-unit fixed-movable (FM3) RBFPDs for replacement of single molar-sized spans.

MATERIALS AND METHODS

Subjects with an 8-10 mm molar-sized edentulous span(s) and 12 pairs of occluding units were randomly assigned to receive either CL2 or FM3 RBFPD (ratio 1:1). The survival (retention of original prosthesis) and success (survival, complication-free) of RBFPDs at one-year were analysed. Patient-reported outcomes were assessed by prosthesis satisfactory questionnaire and Oral Health Impact Profile (OHIP-49). Data in mean, proportion and longevity were analysed by t-test/Mann-Whitney U test/Wilcoxon signed-rank test, chi-square and log-rank tests respectively at significance level α = 0.05.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier NCT02239718.

RESULTS

Ninety-eight RBFPDs (42 CL2 and 56 FM3) were delivered in eighty-three patients. Majority (n = 89) of the prostheses were provided by operators who have less than 2 years of clinical experience. Sixty-six patients with seventy-eight RBFPDs (35 CL2 and 43 FM3) were reviewed at one-year. One CL2 and one FM3 RBFPDs debonded, resulting in a success rate at 97.1 % and 97.7 % respectively (P > 0.05). Both RBFPDs were rebonded and the survival rate were 100 % for both designs. No significant difference in satisfactions and summary OHIP-49 scores were observed (P > 0.05).

CONCLUSION

CL2 RBFPDs can be used for replacing molar-sized edentulous spans with minimal observable complications up to one-year. Longer-term data is being collected.

CLINICAL SIGNIFICANCE

This clinical trial demonstrates CL2 RBFPDs have comparable clinical and patient-reported outcomes as the FM3 design. This challenges the current dogma in prosthodontics and expands the clinical use of CL2 design which is more conservative, simpler and easier for patients to maintain.

摘要

目的

研究 2 个单位的悬臂式(CL2)和 3 个单位的固定可动式(FM3)RBFPD 修复单个磨牙缺失跨度的短期临床效果和患者报告的结果。

材料和方法

选择 8-10mm 磨牙缺失跨度和 12 对咬合单位的患者,随机分配接受 CL2 或 FM3 RBFPD(比例 1:1)。分析 RBFPD 一年时的存活率(保留原始修复体)和成功率(存活率、无并发症)。通过修复体满意度问卷和口腔健康影响量表(OHIP-49)评估患者报告的结果。采用 t 检验/曼-惠特尼 U 检验/威尔科克森符号秩检验、卡方检验和对数秩检验分别分析均值、比例和寿命数据,显著性水平α=0.05。

试验注册

ClinicalTrials.gov 标识符 NCT02239718。

结果

83 名患者共交付 98 个 RBFPD(42 个 CL2 和 56 个 FM3)。大多数(n=89)修复体由临床经验不足 2 年的医生提供。66 名患者(78 个 RBFPD,35 个 CL2 和 43 个 FM3)在一年时进行了复查。1 个 CL2 和 1 个 FM3 RBFPD 脱胶,成功率分别为 97.1%和 97.7%(P>0.05)。这两种 RBFPD 都进行了重新粘接,两种设计的存活率均为 100%。在满意度和 OHIP-49 总分评分方面没有观察到显著差异(P>0.05)。

结论

CL2 RBFPD 可用于修复磨牙缺失跨度,1 年内并发症最小。正在收集更长时间的数据。

临床意义

本临床试验表明,CL2 RBFPD 的临床效果和患者报告的结果与 FM3 设计相当。这对修复学中的现有观念提出了挑战,并扩大了 CL2 设计的临床应用,CL2 设计更保守、更简单,患者更容易维护。

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