Multicenter Study of Denture Adhesive (DAG)
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.
|Edentulous||Other: Denture Adhesives: Cream Other: Denture Adhesives: Powder Other: Saline|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline|
- General satisfaction Patient reported outcomes [ Time Frame: day 3 of adhesives application ]General satisfaction (100mm visual analogue scale)
- Moisture Objective outcomes [ Time Frame: day 3 of each adhesives application ]moisture(%)
- masticatory function [ Time Frame: day 3 of each adhesives application ]Color change of chewing gum measured by color sensing machine (color scale: categorical)
- retentive force [ Time Frame: day 3 of each adhesives application ]The maximum occlusal force that can bite before denture moves(N)
- Oral related quality of life [ Time Frame: day 3 of adhesives application ]Oral health impact profile (OHIP) edentulous Japanese version
|Actual Study Start Date:||December 2012|
|Study Completion Date:||March 2017|
|Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Experimental: Denture Adhesives: Cream
Parallel arm that receives application of Cream denture adhesives.
Other: Denture Adhesives: Cream
Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.
Other Name: Polident
Experimental: Denture Adhesives: Powder
Parallel arm that receives application of powder denture adhesive.
Other: Denture Adhesives: Powder
Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.
Other Name: Poligrip powder
Placebo Comparator: control
Parallel arm that receive placebo.
work as control for Denture Adhesives: Cream and Powder
Other Name: Otsuka normal saline
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712802
|Matsudo, Chiba, Japan, 2718587|
|Study Chair:||Yasuhiko Kawai, DDS MSc PhD||Nihon University|