NCT01712802

Multicenter Study of Denture Adhesive

Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Nihon University · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Accepted

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).

Conditions

• Edentulous

Interventions

Type	Name	Description
OTHER	Denture Adhesives: Cream	Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.
OTHER	Denture Adhesives: Powder	Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.
OTHER	Saline	work as control for Denture Adhesives: Cream and Powder

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-02-01
• Completion: 2017-03-01
• First posted: 2012-10-24
• Last updated: 2017-03-29

Locations

1 site across 1 country: Japan