Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2012-12-31
2017-03-31
Brief Summary
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The null hypotheses are that there are no difference on improvement from baseline to post application of two adhesives powder and cream, in terms of general satisfaction, oral related quality of life, masticatory function and oral conditions.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Denture Adhesives: Cream
Parallel arm that receives application of Cream denture adhesives.
Denture Adhesives: Cream
Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.
Denture Adhesives: Powder
Parallel arm that receives application of powder denture adhesive.
Denture Adhesives: Powder
Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.
control
Parallel arm that receive placebo.
Saline
work as control for Denture Adhesives: Cream and Powder
Interventions
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Denture Adhesives: Cream
Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.
Denture Adhesives: Powder
Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.
Saline
work as control for Denture Adhesives: Cream and Powder
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Deteriorating general conditions
* Maxillofacial defect
* Metal denture user
* Already denture adhesive users
* Severe xerostomia
50 Years
90 Years
ALL
Yes
Sponsors
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Iwate Medical University
OTHER
Tohoku University
OTHER
Tsurumi University
OTHER
Kanagawa Dental University Junior College
OTHER
Tokyo Medical and Dental University
OTHER
Osaka Dental University
UNKNOWN
Hiroshima University
OTHER
University of Tokushima
OTHER
Nagasaki University
OTHER
Kagoshima University
OTHER
Nihon University
OTHER
Responsible Party
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Yasuhiko Kawai
Professor
Principal Investigators
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Yasuhiko Kawai, DDS MSc PhD
Role: STUDY_CHAIR
Nihon University
Locations
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Nihon University
Matsudo, Chiba, Japan
Countries
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References
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Ohwada G, Minakuchi S, Sato Y, Kondo H, Nomura T, Tsuboi A, Hong G, Itoh Y, Kawai Y, Kimoto S, Gunji A, Suzuki A, 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. Subjective Evaluation of Denture Adhesives: A Multicenter Randomized Controlled Trial. JDR Clin Trans Res. 2020 Jan;5(1):50-61. doi: 10.1177/2380084419837607. Epub 2019 Apr 11.
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. 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. Trials. 2016 Oct 18;17(1):506. doi: 10.1186/s13063-016-1612-x.
Other Identifiers
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KAKEN-24390439
Identifier Type: -
Identifier Source: org_study_id
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