title: 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.
abstract: 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.
authors.affiliation: 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. kimoto.suguru@nihon-u.ac.jp.|Department of Removable Prosthodontics, Nihon University School of Dentistry at Matsudo, 2-870-1 Sakaecho-nishi, Matsudo, Chiba, 271-8587, Japan. kimoto.suguru@nihon-u.ac.jp.
authors.forename: Suguru
authors.identifier: 0000-0001-5050-5742
authors.initials: S
authors.lastname: Kimoto
authors.affiliation: 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.
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Kawai
authors.affiliation: 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.
authors.forename: Atsuko
authors.initials: A
authors.lastname: Gunji
authors.affiliation: 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 Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Hisatomo
authors.initials: H
authors.lastname: Kondo
authors.affiliation: 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 Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Taro
authors.initials: T
authors.lastname: Nomura
authors.affiliation: 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 Prosthodontics and Oral Implantology, School of Dentistry, Iwate Medical University, 19-1 Uchimaru, Morioka, 020-8505, Japan.
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Murakami
authors.affiliation: 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.|Division of Community Oral Health Science, Department of Community Medical Supports, Tohoku Medecal Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8573, Japan.
authors.forename: Akito
authors.initials: A
authors.lastname: Tsuboi
authors.affiliation: 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.|Division of Community Oral Health Science, Department of Community Medical Supports, Tohoku Medecal Megabank Organization, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8573, Japan.
authors.forename: Guang
authors.initials: G
authors.lastname: Hong
authors.affiliation: 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.|Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo, 113-8549, Japan.
authors.forename: Shunsuke
authors.initials: S
authors.lastname: Minakuchi
authors.affiliation: 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.|Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo, 113-8549, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Sato
authors.affiliation: 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.|Gerodontology and Oral Rehabilitation, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo, 113-8549, Japan.
authors.forename: Gaku
authors.initials: G
authors.lastname: Ohwada
authors.affiliation: 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.|Section of Oral Prosthetic Engineering, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo, Tokyo, 113-8549, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Suzuki
authors.affiliation: 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.|Division of Prosthodontics & Oral Rehabilitation, Department of Oral Function and Restoration, Graduate School of Dentistry, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan.
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Kimoto
authors.affiliation: 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.|Division of Prosthodontics & Oral Rehabilitation, Department of Oral Function and Restoration, Graduate School of Dentistry, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Hoshi
authors.affiliation: 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.|Division of Prosthodontics & Oral Rehabilitation, Department of Oral Function and Restoration, Graduate School of Dentistry, Kanagawa Dental University, 82 Inaoka-cho, Yokosuka, Kanagawa, 238-8580, Japan.
authors.forename: Makiko
authors.initials: M
authors.lastname: Saita
authors.affiliation: 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, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Yoneyama
authors.affiliation: 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, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501, Japan.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Sato
authors.affiliation: 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.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Morokuma
authors.affiliation: 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, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka, 540-0008, Japan.
authors.forename: Joji
authors.initials: J
authors.lastname: Okazaki
authors.affiliation: 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, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka, 540-0008, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Maeda
authors.affiliation: 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, Occlusion Osaka Dental University, 1-5-17 Otemae, Chuo-ku, Osaka, 540-0008, Japan.
authors.forename: Kenichiro
authors.initials: K
authors.lastname: Nakai
authors.affiliation: 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 Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8504, Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Ichikawa
authors.affiliation: 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 Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8504, Japan.
authors.forename: Kan
authors.initials: K
authors.lastname: Nagao
authors.affiliation: 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 Oral and Maxillofacial Prosthodontics, Graduate School of Biomedical Sciences, Tokushima University, 3-18-15 Kuramoto, Tokushima, 770-8504, Japan.
authors.forename: Keiko
authors.initials: K
authors.lastname: Fujimoto
authors.affiliation: 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 Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Murata
authors.affiliation: 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 Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan.
authors.forename: Tadafumi
authors.initials: T
authors.lastname: Kurogi
authors.affiliation: 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 Prosthetic Dentistry, Graduate School of Biomedical Sciences, Nagasaki University, 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yoshida
authors.affiliation: 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 Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutic, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima, 890-8544, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Nishimura
authors.affiliation: 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 Oral and Maxillofacial Prosthodontics, Field of Oral and Maxillofacial Rehabilitation, Course for Advanced Therapeutic, Kagoshima University Graduate School of Medical and Dental Sciences, Sakuragaoka 8-35-1, Kagoshima, 890-8544, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Nishi
authors.affiliation: 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.|Denture Prosthodontic Restoration, Advanced Dentistry Center, Kagoshima University Medical and Dental Hospital, Sakuragaoka 8-35-1, Kagoshima, 890-8544, Japan.
authors.forename: Mamoru
authors.initials: M
authors.lastname: Murakami
authors.affiliation: 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.|Tsurumi University, 2-1-3 Tsurumi, Tsurumi-ku, Kanagawa, 230-8501, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Hosoi
authors.affiliation: 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.|Hiroshima University, Kasumi 1-2-3, Minamiku, Hiroshima, 734-8553, Japan.
authors.forename: Taizo
authors.initials: T
authors.lastname: Hamada
mesh_terms: D000269:Adhesives; D002985:Clinical Protocols; D003824:Denture, Complete; D006801:Humans; D017410:Practice Guidelines as Topic
chemical_list: D000269:Adhesives
keywords: Complete denture; Denture adhesive; Edentulism; Masticatory performance; Occlusal bite force; Oral health-related quality of life; Retentive force