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Multicenter Study of Denture Adhesive (DAG)

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ClinicalTrials.gov Identifier: NCT01712802
Recruitment Status : Completed
First Posted : October 24, 2012
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Edentulous Other: Denture Adhesives: Cream Other: Denture Adhesives: Powder Other: 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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
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
Actual Study Start Date : December 2012
Primary Completion Date : February 2017
Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Secondary Outcome Measures :
  1. Moisture Objective outcomes [ Time Frame: day 3 of each adhesives application ]

  2. masticatory function [ Time Frame: day 3 of each adhesives application ]
    Color change of chewing gum measured by color sensing machine (color scale: categorical)

  3. retentive force [ Time Frame: day 3 of each adhesives application ]
    The maximum occlusal force that can bite before denture moves(N)

  4. Oral related quality of life [ Time Frame: day 3 of adhesives application ]
    Oral health impact profile (OHIP) edentulous Japanese version

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712802

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
Study Chair: Yasuhiko Kawai, DDS MSc PhD Nihon University