NCT01712802|Completed
Multicenter Study of Denture Adhesive
DAG
Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline
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DAG
Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline
Sponsor study identifier
interventional
200
1 country
1
Study Start
December 2012
Actual (reported)Primary Completion
February 2017
Actual (reported)Study Completion
March 2017
Actual (reported)To establish evidence based guidelines for denture adhesives (powder and cream), multicenter cross over randomized clinical trial will be carried out. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2012
Actual (reported)October 24, 2012
Actual (reported)December 2012
Actual (reported)February 2017
Actual (reported)March 2017
Actual (reported)General satisfaction Patient reported outcomes
General satisfaction (100mm visual analogue scale)
day 3 of adhesives application
Moisture Objective outcomes
day 3 of each adhesives application
masticatory function
day 3 of each adhesives application
retentive force
day 3 of each adhesives application
Oral related quality of life
day 3 of adhesives application
Parallel arm that receives application of Cream denture adhesives.
Parallel arm that receives application of powder denture adhesive.
Parallel arm that receive placebo.
Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.
Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.
Nihon University
Matsudo, Chiba, 2718587, Japan
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.
Yasuhiko Kawai, DDS MSc PhD
Nihon University
200 participants (actual enrollment reported by the registry).
First Submitted
October 17, 2012
First Posted
October 24, 2012
Study Start
December 2012
Actual (reported)work as control for Denture Adhesives: Cream and Powder
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 2017
Actual (reported)Study Completion
March 2017
Actual (reported)Last Updated
March 29, 2017
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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