- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01712802
Multicenter Study of Denture Adhesive (DAG)
Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Chiba
-
Matsudo, Chiba, Japan, 2718587
- Nihon University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- edentulous
Exclusion Criteria:
- Cannot answer the questionnaire
- Deteriorating general conditions
- Maxillofacial defect
- Metal denture user
- Already denture adhesive users
- Severe xerostomia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Denture Adhesives: Cream
Parallel arm that receives application of Cream denture adhesives.
|
Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.
Other Names:
|
Experimental: Denture Adhesives: Powder
Parallel arm that receives application of powder denture adhesive.
|
Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.
Other Names:
|
Placebo Comparator: control
Parallel arm that receive placebo.
|
work as control for Denture Adhesives: Cream and Powder
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General satisfaction Patient reported outcomes
Time Frame: day 3 of adhesives application
|
General satisfaction (100mm visual analogue scale)
|
day 3 of adhesives application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moisture Objective outcomes
Time Frame: day 3 of each adhesives application
|
moisture(%)
|
day 3 of each adhesives application
|
masticatory function
Time Frame: day 3 of each adhesives application
|
Color change of chewing gum measured by color sensing machine (color scale: categorical)
|
day 3 of each adhesives application
|
retentive force
Time Frame: day 3 of each adhesives application
|
The maximum occlusal force that can bite before denture moves(N)
|
day 3 of each adhesives application
|
Oral related quality of life
Time Frame: day 3 of adhesives application
|
Oral health impact profile (OHIP) edentulous Japanese version
|
day 3 of adhesives application
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Yasuhiko Kawai, DDS MSc PhD, Nihon University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAKEN-24390439
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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