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

被引：7

作者：

Kimoto, Suguru ^{[1
,2
]}

Kawai, Yasuhiko ^{[1
,2
]}

Gunji, Atsuko ^{[1
,2
]}

Kondo, Hisatomo ^{[1
,3
]}

Nomura, Taro ^{[1
,3
]}

Murakami, Tomohiko ^{[1
,3
]}

Tsuboi, Akito ^{[1
,4
]}

Hong, Guang ^{[1
,4
]}

Minakuchi, Shunsuke ^{[1
,5
]}

Sato, Yusuke ^{[1
,5
]}

Ohwada, Gaku ^{[1
,5
]}

Suzuki, Tetsuya ^{[1
,6
]}

Kimoto, Katsuhiko ^{[1
,7
]}

Hoshi, Noriyuki ^{[1
,7
]}

Saita, Makiko ^{[1
,7
]}

Yoneyama, Yoshikazu ^{[1
,8
]}

Sato, Yohei ^{[1
,8
]}

Morokuma, Masakazu ^{[1
]}

Okazaki, Joji ^{[1
,9
]}

Maeda, Takeshi ^{[1
,9
]}

Nakai, Kenichiro ^{[1
,9
]}

Ichikawa, Tetsuo ^{[1
,10
]}

Nagao, Kan ^{[1
,10
]}

Fujimoto, Keiko ^{[1
,10
]}

Murata, Hiroshi ^{[1
,11
]}

Kurogi, Tadafumi ^{[1
,11
]}

Yoshida, Kazuhiro ^{[1
,11
]}

Nishimura, Masahiro ^{[1
,12
]}

Nishi, Yasuhiro ^{[1
,12
]}

Murakami, Mamoru ^{[1
,13
]}

Hosoi, Toshio ^{[1
,14
]}

Hamada, Taizo ^{[1
,15
]}

机构：

[1] Tsurumi Univ, Sch Dent Med, Dept Removable Prosthodont, Adm Off,Denture Care Soc,Tsurumi Ku, 2-1-3 Tsurumi, Kanagawa 2308501, Japan

[2] Nihon Univ, Sch Dent Matsudo, Dept Removable Prosthodont, 2-870-1 Sakaecho Nishi, Matsudo, Chiba 2718587, Japan

[3] Iwate Med Univ, Sch Dent, Dept Prosthodont & Oral Implantol, 19-1 Uchimaru, Morioka, Iwate 0208505, Japan

[4] Tohoku Univ, Tohoku Medecal Megabank Org, Dept Community Med Supports, Div Community Oral Hlth Sci,Aoba Ku, 2-1 Seiryo Machi, Sendai, Miyagi 9808573, Japan

[5] Tokyo Med & Dent Univ, Grad Sch Med & Dent Sci, Gerodontol & Oral Rehabil, Bunkyo Ku, 1-5-45 Yushima, Tokyo 1138549, Japan

[6] Tokyo Med & Dent Univ, Sect Oral Prosthet Engn, Bunkyo Ku, 1-5-45 Yushima, Tokyo 1138549, Japan

[7] Kanagawa Dent Univ, Grad Sch Dent, Dept Oral Funct & Restorat, Div Prosthodont & Oral Rehabil, 82 Inaoka Cho, Yokosuka, Kanagawa 2388580, Japan

[8] Tsurumi Univ, Sch Dent Med, Dept Removable Prosthodont, Tsurumi Ku, 2-1-3 Tsurumi, Kanagawa 2308501, Japan

[9] Occlus Osaka Dent Univ, Dept Removable Prosthodont, Chuo Ku, 1-5-17 Otemae, Osaka 5400008, Japan

[10] Univ Tokushima, Grad Sch Biomed Sci, Dept Oral & Maxillofacial Prosthodont, 3-18-15 Kuramoto, Tokushima 7708504, Japan

[11] Nagasaki Univ, Grad Sch Biomed Sci, Dept Prosthet Dent, 1-7-1 Sakamoto, Nagasaki 8528588, Japan

[12] Kagoshima Univ, Dept Oral & Maxillofacial Prosthodont, Field Oral & Maxillofacial Rehabil, Grad Sch Med & Dent Sci,Course Adv Therapeut, Sakuragaoka 8-35-1, Kagoshima 8908544, Japan

[13] Kagoshima Univ, Med & Dent Hosp, Denture Prosthodont Restorat, Adv Dent Ctr, Sakuragaoka 8-35-1, Kagoshima 8908544, Japan

[14] Tsurumi Univ, Tsurumi Ku, 2-1-3 Tsurumi, Kanagawa 2308501, Japan

[15] Hiroshima Univ, Minami Ku, Kasumi 1-2-3, Hiroshima 7348553, Japan

来源：

TRIALS | 2016年 / 17卷

基金：

日本学术振兴会;

关键词：

Complete denture; Edentulism; Denture adhesive; Retentive force; Occlusal bite force; Masticatory performance; Oral health-related quality of life; MAXILLARY DENTURES; RETENTION; SATISFACTION; STABILITY; MOVEMENT;

D O I：

10.1186/s13063-016-1612-x

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：8

共 30 条

[1] DENTURE ADHESIVES - THEIR EFFECTS ON DENTURE RETENTION AND STABILITY [J].