Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial.
Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial.
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DOI：
10.1186/s13063-016-1612-x
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发表时间：
2016-10-18
期刊：
影响因子：
2.5
通讯作者：
Hamada T
中科院分区：
文献类型：
--
作者：
Kimoto S;Kawai Y;Gunji A;Kondo H;Nomura T;Murakami T;Tsuboi A;Hong G;Minakuchi S;Sato Y;Ohwada G;Suzuki T;Kimoto K;Hoshi N;Saita M;Yoneyama Y;Sato Y;Morokuma M;Okazaki J;Maeda T;Nakai K;Ichikawa T;Nagao K;Fujimoto K;Murata H;Kurogi T;Yoshida K;Nishimura M;Nishi Y;Murakami M;Hosoi T;Hamada T
1935年，美国牙科协会将义齿粘合剂定性为医疗产品，认为它是改善义齿固位和稳定性的有用粘合剂。然而，日本的许多牙科医生在日常实践中不愿承认义齿粘合剂，因为刻板印象认为义齿应该是内在稳定的，没有粘合剂的帮助。本研究的目的是验证义齿粘合剂的有效性，为日本用户制定指南。零假设是，使用义齿粘合剂（包括乳膏和粉末类型）或对照（等渗氯化钠溶液）不会产生不同的结果，也不会在基线和使用后第4天之间差异性地改善设定的结果。这项平行组的10中心随机对照试验正在进行中。将300名全口义齿无牙患者分为三组（乳膏型粘合剂组、粉末型粘合剂组和对照组）。参与者将使用义齿粘合剂佩戴义齿4天，包括8餐（三顿早餐，两顿午餐和三顿晚餐）。将在第一天和第四天早餐后进行义齿粘合剂的基线测量和最终测量。主要结果是对义齿的总体满意度。次要结果是各种义齿功能的义齿满意度评级，咬合力，抗脱位，咀嚼性能，感知咀嚼能力和口腔健康相关的生活质量。将进行三组之间的受试者间比较以及干预前后测量值的受试者内比较。此外，还将进行多元回归分析。主要分析将基于意向治疗原则。需要每组100例受试者的样本量，包括10%的假设脱落率，以在5%的α水平下达到80%的把握度。这项随机临床试验将为日本的全口义齿佩戴者、口腔修复教育者和牙医提供有关义齿粘合剂的信息。我们相信，来自日本的关于义齿粘合剂使用的新证据将有助于牙科医生的日常实践，甚至在其他国家。ClinicalTrials.gov NCT01712802。2012年10月17日登记。
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.
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DOI：
10.1111/j.1532-849x.2005.00020.x
发表时间：
2005-06-01
期刊：
Journal of prosthodontics : official journal of the American College of Prosthodontists
影响因子：
--
作者：
Ozcan, Mutlu;Kulak, Yasemin;Ucankale, Mert
通讯作者：
Ucankale, Mert
DOI：
10.1111/j.1532-849x.2010.00601.x
发表时间：
2010-08-01
影响因子：
4
作者：
Nicolas, Emmanuel;Veyrune, Jean-luc;Lassauzay, Claire
通讯作者：
Lassauzay, Claire
影响因子：
4.4
作者：
Kawai, Y;Murakami, H;Feine, JS
通讯作者：
Feine, JS
影响因子：
4.6
作者：
KAPUR, KK
通讯作者：
KAPUR, KK
影响因子：
3.6
作者：
Murakami, Mamoru;Nishi, Yasuhiro;Nagaoka, Eiichi
通讯作者：
Nagaoka, Eiichi