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| Name | Class |
|---|---|
| Iwate Medical University | OTHER |
| Tohoku University | OTHER |
| Tsurumi University | OTHER |
| Kanagawa Dental University Junior College |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denture Adhesives: Cream | Experimental | Parallel arm that receives application of Cream denture adhesives. |
|
| Denture Adhesives: Powder | Experimental | Parallel arm that receives application of powder denture adhesive. |
|
| control | Placebo Comparator | Parallel arm that receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denture Adhesives: Cream | Other | Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| General satisfaction Patient reported outcomes | General satisfaction (100mm visual analogue scale) | day 3 of adhesives application |
| Measure | Description | Time Frame |
|---|---|---|
| Moisture Objective outcomes | moisture(%) | day 3 of each adhesives application |
| masticatory function | Color change of chewing gum measured by color sensing machine (color scale: categorical) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasuhiko Kawai, DDS MSc PhD | Nihon University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nihon University | Matsudo | Chiba | 2718587 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30975019 | Derived | 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. | |
| 27756441 |
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| ID | Term |
|---|---|
| D009066 | Mouth, Edentulous |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| C102654 | Polident |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| OTHER |
| Tokyo Medical and Dental University | OTHER |
| Osaka Dental University | UNKNOWN |
| Hiroshima University | OTHER |
| University of Tokushima | OTHER |
| Nagasaki University | OTHER |
| Kagoshima University | OTHER |
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| Denture Adhesives: Powder | Other | Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes. |
|
|
| Saline | Other | work as control for Denture Adhesives: Cream and Powder |
|
|
| day 3 of each adhesives application |
| retentive force | The maximum occlusal force that can bite before denture moves(N) | day 3 of each adhesives application |
| Oral related quality of life | Oral health impact profile (OHIP) edentulous Japanese version | day 3 of adhesives application |
| Derived |
| 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. |
| D017670 |
| Sodium Compounds |