Multicenter Study of Denture Adhesive

Overview

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.

Full Title of Study: “Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: February 2017

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).

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Denture Adhesives: Cream
    • Parallel arm that receives application of Cream denture adhesives.
  • Experimental: Denture Adhesives: Powder
    • Parallel arm that receives application of powder denture adhesive.
  • Placebo Comparator: control
    • Parallel arm that receive placebo.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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

Participating in This Clinical Trial

Inclusion Criteria

  • edentulous

Exclusion Criteria

  • Cannot answer the questionnaire
  • Deteriorating general conditions
  • Maxillofacial defect
  • Metal denture user
  • Already denture adhesive users
  • Severe xerostomia

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Nihon University
  • Collaborator
    • Iwate Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yasuhiko Kawai, Professor – Nihon University
  • Overall Official(s)
    • Yasuhiko Kawai, DDS MSc PhD, Study Chair, Nihon University

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