Clinical trial NCT01712802: Multicenter Study of Denture Adhesive
Official title: Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous
Lead sponsor: Nihon University
Sponsor class: OTHER
Collaborators: name: Iwate Medical University
name: Tohoku University
name: Tsurumi University
name: Kanagawa Dental University Junior College
name: Tokyo Medical and Dental University
name: Osaka Dental University
name: Hiroshima University
name: University of Tokushima
name: Nagasaki University
name: Kagoshima University
First posted: 2012-10-24
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is multicenter study of 10 academic affiliated institutions. The clinical trial will be carried out in randomized allocation at each site, and data will be gathered. The intervention will be 3-arms and center institution (Nihon University) will generate each site random numbers for allocation and each site will follow this randomization. Research protocol had been published at Nihon University and distributed to each site.To survey its protocol compliance, the study meeting will be held periodically (twice an year).

Eligibility criteria: Inclusion Criteria:

* edentulous

Exclusion Criteria:

* Cannot answer the questionnaire
* Deteriorating general conditions
* Maxillofacial defect
* Metal denture user
* Already denture adhesive users
* Severe xerostomia

Primary outcomes:
measure: General satisfaction Patient reported outcomes
timeFrame: day 3 of adhesives application
Secondary outcomes:
measure: Moisture Objective outcomes
timeFrame: day 3 of each adhesives application
measure: masticatory function
timeFrame: day 3 of each adhesives application
measure: retentive force
timeFrame: day 3 of each adhesives application
measure: Oral related quality of life
timeFrame: day 3 of adhesives application
Other outcomes:
Locations:
city: Matsudo
country: Japan
facility: Nihon University
state: Chiba
Study officials:
affiliation: Nihon University
name: Yasuhiko Kawai, DDS MSc PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.