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Multicenter Study of Denture Adhesive (DAG)

This study is not yet open for participant recruitment.
Verified November 2012 by Nihon University
Sponsor:
Collaborators:
Iwate Medical University
Tohoku University
Tsurumi University
Kanagawa Dental College
Tokyo Medical and Dental University
Osaka Dental University
Hiroshima University
The 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: November 1, 2012
Last verified: November 2012
History of Changes
  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 Phase
Edentulous
 Other: Denture Adhesives: Cream
Other: Denture Adhesives: Powder
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Dentures
U.S. FDA Resources

Further study details as provided by Nihon University:

Primary Outcome Measures:
  • General satisfaction Patient reported outcomes [ Time Frame: day 3 of adhesives application ] [ Designated as safety issue: No ]
    General satisfaction (100mm visual analogue scale)

  • Oral related quality of life [ Time Frame: day 3 of adhesives application ] [ Designated as safety issue: No ]
    Oral health impact profile (OHIP) edentulous Japanese version


Secondary Outcome Measures:
  • Moisture Objective outcomes [ Time Frame: day 3 of each adhesives application ] [ Designated as safety issue: No ]
    moisture(%)

  • masticatory function [ Time Frame: day 3 of each adhesives application ] [ Designated as safety issue: No ]
    Color change of chewing gum measured by color sensing machine (color scale: categorical)

  • retentive force [ Time Frame: day 3 of each adhesives application ] [ Designated as safety issue: No ]
    The maximum occlusal force that can bite before denture moves(N)


Estimated Enrollment: 330
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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
Experimental: Denture Adhesives: Powder
Parallel arm that receives application of powder denture adhesive.
 Other: Denture Adhesives: Powder
Placebo Comparator: control
Parallel arm that receive placebo.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • edentulous

Exclusion Criteria:

  • cannot answer the questionnaire
  • deteriorating general conditions
  • maxillo-facial defect
  • metal denture user
  • already denture adhesive users
  • Severe Xerostomia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712802

Contacts
Contact: Yasuhiko Kawai, DDS MSc PhD 81473609378 kawai.yasuhiko@nihon-u.ac.jp

Locations
Japan
Nihon University Not yet recruiting
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
The University of Tokushima
Nagasaki University
Kagoshima University
  More Information

No publications provided

Responsible Party: Yasuhiko Kawai, Professor, Nihon University
ClinicalTrials.gov Identifier: NCT01712802     History of Changes
Other Study ID Numbers: KAKEN-24390439
Study First Received: October 17, 2012
Last Updated: November 1, 2012
Health Authority: Japan: Japan society for the promotion of science

Additional relevant MeSH terms:
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on May 21, 2013