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ID 115820
Author
Kimoto, Suguru Tsurumi University|Nihon University
Kawai, Yasuhiko Tsurumi University|Nihon University
Gunji, Atsuko Tsurumi University|Nihon University
Kondo, Hisatomo Tsurumi University|Iwate Medical University
Nomura, Taro Tsurumi University|Iwate Medical University
Murakami, Tomohiko Tsurumi University|Iwate Medical University
Tsuboi, Akito Tsurumi University|Tohoku University
Hong, Guang Tsurumi University|Tohoku University
Minakuchi, Shunsuke Tsurumi University|Tokyo Medical and Dental University
Sato, Yusuke Tsurumi University|Tokyo Medical and Dental University
Ohwada, Gaku Tsurumi University|Tokyo Medical and Dental University
Suzuki, Tetsuya Tsurumi University|Tokyo Medical and Dental University
Kimoto, Katsuhiko Tsurumi University|Kanagawa Dental University
Hoshi, Noriyuki Tsurumi University|Kanagawa Dental University
Saita, Makiko Tsurumi University|Kanagawa Dental University
Yoneyama, Yoshikazu Tsurumi University
Sato, Yohei Tsurumi University
Morokuma, Masakazu Tsurumi University
Okazaki, Joji Tsurumi University|Osaka Dental University
Maeda, Takeshi Tsurumi University|Osaka Dental University
Nakai, Kenichiro Tsurumi University|Osaka Dental University
Murata, Hiroshi Tsurumi University|Nagasaki University
Kurogi, Tadafumi Tsurumi University|Nagasaki University
Yoshida, Kazuhiro Tsurumi University|Nagasaki University
Nishimura, Masahiro Tsurumi University|Kagoshima University
Nishi, Yasuhiro Tsurumi University|Kagoshima University
Murakami, Mamoru Tsurumi University|Kagoshima University
Hosoi, Toshio Tsurumi University
Hamada, Taizo Tsurumi University|Hiroshima University
Keywords
Complete denture
Edentulism
Denture adhesive
Retentive force
Occlusal bite force
Masticatory performance
Oral health-related quality of life
Content Type
Journal Article
Description
Background: 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.
Methods: 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.
Discussion: 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.
Journal Title
Trials
ISSN
17456215
Publisher
BioMed Central|Springer Nature
Volume
17
Start Page
506
Published Date
2016-10-18
Rights
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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language
eng
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departments
Oral Sciences