Multicenter Study of Denture Adhesive

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline

Conditions
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Edentulous

Intervention / Treatment
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* Other: Denture Adhesives: Cream
* Other: Denture Adhesives: Powder
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: edentulous Exclusion Criteria: Cannot answer the questionnaire Deteriorating general conditions Maxillofacial defect Metal denture user Already denture adhesive users Severe xerostomia

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denture Adhesives: Cream<br>Parallel arm that receives application of Cream denture adhesives. | Other: Denture Adhesives: Cream<br>* Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.<br>* Other names: Polident;|
| Experimental: Denture Adhesives: Powder<br>Parallel arm that receives application of powder denture adhesive. | Other: Denture Adhesives: Powder<br>* Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.<br>* Other names: Poligrip powder;|
| Placebo Comparator: control<br>Parallel arm that receive placebo. | Other: Saline<br>* work as control for Denture Adhesives: Cream and Powder<br>* Other names: Otsuka normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General satisfaction Patient reported outcomes | General satisfaction (100mm visual analogue scale) | day 3 of adhesives application | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |