Multicenter Study of Denture Adhesive

Edentulous Clinical Trial

— DAG  

Official title:

Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01712802
• Other study ID #: KAKEN-24390439
• Status: Completed
• Phase: N/A
• First received: October 17, 2012
• Last updated: March 27, 2017
• Start date: December 2012
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Nihon University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Edentulous

Intervention

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

Locations

Country	Name	City	State
Japan	Nihon University	Matsudo	Chiba

Sponsors (11)

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

Country where clinical trial is conducted

Japan, 

Outcome

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