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Multicenter Study of Denture Adhesive (DAG)

This study has been completed.
Sponsor:
Collaborators:
Iwate Medical University
Tohoku University
Tsurumi University
Kanagawa Dental College
Tokyo Medical and Dental University
Osaka Dental University
Hiroshima University
University of Tokushima
Nagasaki University
Kagoshima University
Information provided by (Responsible Party):
Yasuhiko Kawai, Nihon University
ClinicalTrials.gov Identifier:
NCT01712802
First received: October 17, 2012
Last updated: March 27, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Edentulous Other: Denture Adhesives: Cream Other: Denture Adhesives: Powder Other: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline

Resource links provided by NLM:


Further study details as provided by Yasuhiko Kawai, Nihon University:

Primary Outcome Measures:
  • General satisfaction Patient reported outcomes [ Time Frame: day 3 of adhesives application ]
    General satisfaction (100mm visual analogue scale)


Secondary Outcome Measures:
  • 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


Enrollment: 200
Actual Study Start Date: December 2012
Study Completion Date: March 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Saline
work as control for Denture Adhesives: Cream and Powder
Other Name: Otsuka normal saline

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).
  Eligibility

Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • edentulous

Exclusion Criteria:

  • Cannot answer the questionnaire
  • Deteriorating general conditions
  • Maxillofacial defect
  • Metal denture user
  • Already denture adhesive users
  • Severe xerostomia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712802

Locations
Japan
Nihon University
Matsudo, Chiba, Japan, 2718587
Sponsors and Collaborators
Nihon University
Iwate Medical University
Tohoku University
Tsurumi University
Kanagawa Dental College
Tokyo Medical and Dental University
Osaka Dental University
Hiroshima University
University of Tokushima
Nagasaki University
Kagoshima University
Investigators
Study Chair: Yasuhiko Kawai, DDS MSc PhD Nihon University