Kimoto Suguru, Kawai Yasuhiko, Gunji Atsuko, Kondo Hisatomo, Nomura Taro, Murakami Tomohiko, Tsuboi Akito, Hong Guang, Minakuchi Shunsuke, Sato Yusuke, Ohwada Gaku, Suzuki Tetsuya, Kimoto Katsuhiko, Hoshi Noriyuki, Saita Makiko, Yoneyama Yoshikazu, Sato Yohei, Morokuma Masakazu, Okazaki Joji, Maeda Takeshi, Nakai Kenichiro, Ichikawa Tetsuo, Nagao Kan, Fujimoto Keiko, Murata Hiroshi, Kurogi Tadafumi, Yoshida Kazuhiro, Nishimura Masahiro, Nishi Yasuhiro, Murakami Mamoru, Hosoi Toshio, Hamada Taizo
The denture care society, Administration Office of Denture Care Society, Department of Removable Prosthodontics, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501, Japan.
Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba, 271-8587, Japan.
Trials. 2016 Oct 18;17(1):506. doi: 10.1186/s13063-016-1612-x.
Denture adhesives, characterized as medical products in 1935 by the American Dental Association, have been considered useful adjuncts for improving denture retention and stability. However, many dentists in Japan are hesitant to acknowledge denture adhesives in daily practice because of the stereotype that dentures should be inherently stable, without the aid of adhesives. The aim of this study is to verify the efficacy of denture adhesives to establish guidelines for Japanese users. The null hypothesis is that the application of denture adhesives, including the cream and powder types, or a control (isotonic sodium chloride solution) would not produce different outcomes nor would they differentially improve the set outcomes between baseline and day 4 post-application.
This ten-center, randomized controlled trial with parallel groups is ongoing. Three hundred edentulous patients with complete dentures will be allocated to three groups (cream-type adhesive, powder-type adhesive, and control groups). The participants will wear their dentures with the denture adhesive for 4 days, including during eight meals (three breakfasts, two lunches, and three dinners). The baseline measurements and final measurements for the denture adhesives will be performed on the first day and after breakfast on the fourth day. The primary outcome is a general satisfaction rating for the denture. The secondary outcomes are denture satisfaction ratings for various denture functions, occlusal bite force, resistance to dislodgement, masticatory performance, perceived chewing ability, and oral health-related quality of life. Between-subjects comparisons among the three groups and within-subjects comparisons of the pre- and post-intervention measurements will be performed. Furthermore, a multiple regression analysis will be performed. The main analyses will be based on the intention-to-treat principle. A sample size of 100 subjects per group, including an assumed dropout rate of 10 %, will be required to achieve 80 % power with a 5 % alpha level.
This randomized clinical trial will provide information about denture adhesives to complete denture wearers, prosthodontic educators, and dentists in Japan. We believe this new evidence on denture adhesive use from Japan will aid dentists in their daily practice even in other countries.
ClinicalTrials.gov NCT01712802 . Registered on 17 October 2012.
假牙粘合剂在1935年被美国牙科协会认定为医疗产品，一直被视为改善假牙固位和稳定性的有用辅助工具。然而，由于存在假牙应天生稳定、无需粘合剂辅助的刻板观念，日本许多牙医在日常实践中对认可假牙粘合剂持犹豫态度。本研究的目的是验证假牙粘合剂的功效，为日本使用者制定指导方针。无效假设是，使用包括乳膏型和粉末型在内的假牙粘合剂或对照物（等渗氯化钠溶液）不会产生不同结果，也不会在基线和应用后第4天之间差异改善既定结果。
这项十中心、平行组随机对照试验正在进行。300名佩戴全口义齿的无牙患者将被分配到三组（乳膏型粘合剂组、粉末型粘合剂组和对照组）。参与者将佩戴含有假牙粘合剂的假牙4天，包括八餐期间（三餐早餐、两餐午餐和三餐晚餐）。假牙粘合剂的基线测量和最终测量将在第一天和第四天早餐后进行。主要结果是对假牙的总体满意度评分。次要结果是对各种假牙功能的假牙满意度评分、咬合咬合力、抗脱位性、咀嚼性能、感知咀嚼能力以及与口腔健康相关的生活质量。将进行三组之间的组间比较以及干预前后测量的组内比较。此外，还将进行多元回归分析。主要分析将基于意向性分析原则。每组需要100名受试者的样本量，包括假设10%的脱落率，以在5%的α水平下达到80%的检验效能。
这项随机临床试验将为日本的全口义齿佩戴者、口腔修复学教育工作者和牙医提供有关假牙粘合剂的信息。我们相信，来自日本的关于假牙粘合剂使用的这一新证据将有助于其他国家的牙医开展日常实践。
ClinicalTrials.gov NCT01712802。于2012年10月17日注册。
