带弹性衬里的下颌全口义齿的临床疗效：一项多中心随机对照试验的研究方案。
Clinical efficacy of mandibular complete dentures with a resilient liner: study protocol for a multicenter randomized controlled trial.
机构信息
Administration Office of the Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, 230-8501, Japan.
Department of Fixed Prosthodontics, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan.
出版信息
Trials. 2022 Sep 2;23(1):738. doi: 10.1186/s13063-022-06657-3.
BACKGROUND
During restoration of poorly fitting complete dentures (CDs) in edentulous patients, liners are used to reconstruct the concave surfaces of CDs with a new base material. These relining materials are classified into resilient liners (RLs) and non-resilient liners (NRLs), but the clinical effects of these liners and their selection criteria remain unclear. The purpose of this study is to evaluate the clinical efficacy of relining mandibular CDs using RL and NRL and to conduct a follow-up study.
METHODS
The study is currently being conducted at eight centers, and a parallel-group randomized controlled trial (RCT) is underway. One hundred thirty-two edentulous patients with poorly fitting mandibular CDs will be assigned to two groups based on whether they will receive RL or NRL. Participants will have an RL or NRL applied for relining their CDs using an indirect method of dynamic impressions. Data will be recorded at 1 week and 3, 6, and 12 months after denture delivery. The primary outcome will be assessment of the patients' general satisfaction by using a 100-mm visual analog scale (VAS). Secondary outcomes will be measured as patient-reported outcomes, including food intake status and oral hygiene-related quality of life. Masticatory performance and the number of sore spots on the oral mucosa will also be recorded. Comparisons between the two groups and within-subject comparisons of pre- and post-intervention measurements will be conducted.
DISCUSSION
For dentists and prosthetic researchers in Japan, this RCT will provide information on the clinical efficacy of RL materials in comparison to RNL in CD wearers. The new evidence regarding the use of RL materials in an aging population will also be useful to dentists in other countries in their routine clinical practice.
TRIAL REGISTRATION
This clinical trial has been registered at the University Hospital Medical Information Network (UMIN) Center (UMIN000041950).
背景
在为牙列缺失患者修复不合适的全口义齿（CD）时，使用衬垫材料来使用新的基底材料重建 CD 的凹面。这些衬垫材料分为弹性衬垫（RL）和非弹性衬垫（NRL），但这些衬垫的临床效果及其选择标准仍不清楚。本研究旨在评估使用 RL 和 NRL 修复下颌 CD 的临床效果，并进行随访研究。
方法
该研究目前正在八个中心进行，正在进行一项平行组随机对照试验（RCT）。将 132 名下颌 CD 不合适的无牙患者根据是否接受 RL 或 NRL 分为两组。参与者将通过动态印模的间接方法为其 CD 应用 RL 或 NRL。将在义齿交付后 1 周和 3、6 和 12 个月记录数据。主要结局将使用 100mm 视觉模拟量表（VAS）评估患者的总体满意度。次要结局将作为患者报告的结果进行测量，包括食物摄入状况和口腔卫生相关的生活质量。咀嚼性能和口腔黏膜上的疼痛点数量也将被记录。将对两组进行比较，并对干预前后的测量值进行组内比较。
讨论
对于日本的牙医和修复研究人员来说，这项 RCT 将提供 RL 材料与 NRL 在 CD 佩戴者中的临床效果比较的信息。有关 RL 材料在老龄化人群中使用的新证据也将对其他国家的牙医在常规临床实践中有所帮助。
试验注册
这项临床试验已在大学医院医疗信息网络（UMIN）中心（UMIN000041950）注册。
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