Faculty of Dental Medicine and Oral Health Sciences, McGill University, Montreal, Canada.
Faculty of Dentistry, Université de Montréal, Montreal, Canada.
JDR Clin Trans Res. 2024 Jan;9(1):27-41. doi: 10.1177/23800844221124083. Epub 2022 Sep 20.
INTRODUCTION: Single-implant mandibular overdentures (SIMOs) are one of the least invasive implant treatments for edentulism. The new Novaloc attachment system can improve the clinical performance of implant-retained overdentures but has not been tested for SIMOs. OBJECTIVES: To compare Novaloc and a gold standard system (Locator) for SIMOs in an edentate elderly population in terms of patient-reported outcomes and device- and treatment-related complications. METHODS: In this single-center crossover randomized clinical trial (RCT), 10 edentulous participants received an implant in the lower midline and had their lower complete dentures converted to SIMOs. The participants received each attachment system for 3 mo in a randomized order, followed by measurement of patient satisfaction and oral health-related quality of life via the McGill Denture Satisfaction Questionnaire and the Oral Health Impact Profile for Edentulous People questionnaire, respectively. Complications were registered throughout the RCT. Patients were interviewed for their experiences with SIMOs and preference for one of the attachment systems. Quantitative analysis employed mixed linear models and chi-square tests (α = 0.05), whereas interview data underwent thematic analysis and, in turn, integration into quantitative data (mixed methods explanatory design). RESULTS: All 10 randomized participants completed the trial. Mean ± SD general satisfaction was 92% ± 8% with Novaloc versus 85% ± 13% with Locator (mean difference, 9%; 95% CI, 1% to 17%). For specific McGill Denture Satisfaction Questionnaire items, only denture stability was significantly increased for Novaloc. Seven participants preferred Novaloc over Locator at the end of the RCT (chi-square, = 0.045). No difference was found between the attachments in terms of oral health-related quality of life based on the Oral Health Impact Profile for Edentulous People and complications. Thematic analysis revealed high patient satisfaction with SIMOs, with denture stability the main criterion for their satisfaction and attachment preference. CONCLUSION: Among elderly edentulous patients wearing SIMOs, Novaloc led to increased patient satisfaction and preference. Better patient-perceived denture stability may explain this result. The attachment systems exhibited similar short-term maintenance needs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03126942 (first registered on April 13, 2017). Secondary identifiers: A03-M07-17A (McGill University, Institutional Review Board) and 2018-3873 (McGill University Health Centre, Research Ethics Board). KNOWLEDGE TRANSFER STATEMENT: The results of this mixed methods study can be used by clinicians when choosing which attachment system to use for SIMOs. Results suggest that edentulous patients prefer attachments with a better-defined seating position, such as that of the Novaloc system, as opposed to the nylon matrix on metallic abutment of the Locator system.
简介:单颗下颌种植覆盖义齿(SIMO)是一种针对无牙颌的微创种植治疗方法。新型 Novaloc 附着体系统可改善种植体支持覆盖义齿的临床性能,但尚未针对 SIMO 进行测试。
目的:在无牙颌老年人群中,比较 Novaloc 和金标准系统(Locator)用于 SIMO 的患者报告结局以及器械和治疗相关并发症。
方法:这是一项单中心交叉随机临床试验(RCT),10 名无牙颌参与者在下颌中线植入一枚种植体,并将其全口义齿转换为 SIMO。参与者以随机顺序分别接受每种附着体系统治疗 3 个月,然后分别通过 McGill 义齿满意度问卷和无牙颌患者口腔健康影响量表评估患者满意度和口腔健康相关生活质量。整个 RCT 期间记录并发症。对患者进行采访,了解他们对 SIMO 的体验和对两种附着体系统的偏好。采用混合线性模型和卡方检验(α=0.05)进行定量分析,而访谈数据则进行主题分析,继而纳入定量数据(混合方法解释性设计)。
结果:10 名随机参与者均完成了试验。Novaloc 的总体满意度为 92%±8%,而 Locator 的总体满意度为 85%±13%(平均差异为 9%;95%CI,1%至 17%)。在 McGill 义齿满意度问卷的特定项目中,只有义齿稳定性在 Novaloc 组显著增加。在 RCT 结束时,有 7 名参与者更喜欢 Novaloc 而不是 Locator(卡方检验,=0.045)。基于无牙颌患者口腔健康影响量表,两种附着体在口腔健康相关生活质量方面没有差异,且并发症也无差异。主题分析显示,患者对 SIMO 非常满意,义齿稳定性是其满意度和附着体偏好的主要标准。
结论:在佩戴 SIMO 的无牙颌老年患者中,Novaloc 提高了患者满意度和偏好。更好的患者感知义齿稳定性可能解释了这一结果。两种附着体系统在短期维护需求方面表现相似。
试验注册:ClinicalTrials.gov:NCT03126942(于 2017 年 4 月 13 日首次注册)。二级标识符:A03-M07-17A(麦吉尔大学,机构审查委员会)和 2018-3873(麦吉尔大学健康中心,伦理审查委员会)。
知识转移声明:本混合方法研究的结果可用于临床医生选择用于 SIMO 的附着体系统。结果表明,无牙颌患者更喜欢具有更明确就位位置的附着体,例如 Novaloc 系统,而不是 Locator 系统的金属基台上的尼龙基托。
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