Edentulous Clinical Trial
— DAGOfficial title:
Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline
Verified date | March 2017 |
Source | Nihon University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | March 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility |
Inclusion Criteria: - edentulous Exclusion Criteria: - Cannot answer the questionnaire - Deteriorating general conditions - Maxillofacial defect - Metal denture user - Already denture adhesive users - Severe xerostomia |
Country | Name | City | State |
---|---|---|---|
Japan | Nihon University | Matsudo | Chiba |
Lead Sponsor | Collaborator |
---|---|
Nihon University | Hiroshima University, Iwate Medical University, Kagoshima University, Kanagawa Dental College, Nagasaki University, Osaka Dental University, Tohoku University, Tokyo Medical and Dental University, Tsurumi University, University of Tokushima |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | General satisfaction Patient reported outcomes | General satisfaction (100mm visual analogue scale) | day 3 of adhesives application | |
Secondary | Moisture Objective outcomes | moisture(%) | day 3 of each adhesives application | |
Secondary | masticatory function | Color change of chewing gum measured by color sensing machine (color scale: categorical) | day 3 of each adhesives application | |
Secondary | retentive force | The maximum occlusal force that can bite before denture moves(N) | day 3 of each adhesives application | |
Secondary | Oral related quality of life | Oral health impact profile (OHIP) edentulous Japanese version | day 3 of adhesives application |
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