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Multicenter Study of Denture Adhesive (DAG)

Primary Purpose

Edentulous

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Denture Adhesives: Cream
Denture Adhesives: Powder
Saline
Sponsored by
Nihon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • edentulous

Exclusion Criteria:

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

Sites / Locations

  • Nihon University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Denture Adhesives: Cream

Denture Adhesives: Powder

control

Arm Description

Parallel arm that receives application of Cream denture adhesives.

Parallel arm that receives application of powder denture adhesive.

Parallel arm that receive placebo.

Outcomes

Primary Outcome Measures

General satisfaction Patient reported outcomes
General satisfaction (100mm visual analogue scale)

Secondary Outcome Measures

Moisture Objective outcomes
moisture(%)
masticatory function
Color change of chewing gum measured by color sensing machine (color scale: categorical)
retentive force
The maximum occlusal force that can bite before denture moves(N)
Oral related quality of life
Oral health impact profile (OHIP) edentulous Japanese version

Full Information

First Posted
October 17, 2012
Last Updated
March 27, 2017
Sponsor
Nihon University
Collaborators
Iwate Medical University, Tohoku University, Tsurumi University, Kanagawa Dental University Junior College, Tokyo Medical and Dental University, Osaka Dental University, Hiroshima University, University of Tokushima, Nagasaki University, Kagoshima University
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1. Study Identification

Unique Protocol Identification Number
NCT01712802
Brief Title
Multicenter Study of Denture Adhesive
Acronym
DAG
Official Title
Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nihon University
Collaborators
Iwate Medical University, Tohoku University, Tsurumi University, Kanagawa Dental University Junior College, Tokyo Medical and Dental University, Osaka Dental University, Hiroshima University, University of Tokushima, Nagasaki University, Kagoshima University

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Denture Adhesives: Cream
Arm Type
Experimental
Arm Description
Parallel arm that receives application of Cream denture adhesives.
Arm Title
Denture Adhesives: Powder
Arm Type
Experimental
Arm Description
Parallel arm that receives application of powder denture adhesive.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Parallel arm that receive placebo.
Intervention Type
Other
Intervention Name(s)
Denture Adhesives: Cream
Other Intervention Name(s)
Polident
Intervention Description
Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.
Intervention Type
Other
Intervention Name(s)
Denture Adhesives: Powder
Other Intervention Name(s)
Poligrip powder
Intervention Description
Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.
Intervention Type
Other
Intervention Name(s)
Saline
Other Intervention Name(s)
Otsuka normal saline
Intervention Description
work as control for Denture Adhesives: Cream and Powder
Primary Outcome Measure Information:
Title
General satisfaction Patient reported outcomes
Description
General satisfaction (100mm visual analogue scale)
Time Frame
day 3 of adhesives application
Secondary Outcome Measure Information:
Title
Moisture Objective outcomes
Description
moisture(%)
Time Frame
day 3 of each adhesives application
Title
masticatory function
Description
Color change of chewing gum measured by color sensing machine (color scale: categorical)
Time Frame
day 3 of each adhesives application
Title
retentive force
Description
The maximum occlusal force that can bite before denture moves(N)
Time Frame
day 3 of each adhesives application
Title
Oral related quality of life
Description
Oral health impact profile (OHIP) edentulous Japanese version
Time Frame
day 3 of adhesives application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: edentulous Exclusion Criteria: Cannot answer the questionnaire Deteriorating general conditions Maxillofacial defect Metal denture user Already denture adhesive users Severe xerostomia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasuhiko Kawai, DDS MSc PhD
Organizational Affiliation
Nihon University
Official's Role
Study Chair
Facility Information:
Facility Name
Nihon University
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
2718587
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30975019
Citation
Ohwada G, Minakuchi S, Sato Y, Kondo H, Nomura T, Tsuboi A, Hong G, Itoh Y, Kawai Y, Kimoto S, Gunji A, Suzuki A, Suzuki T, Kimoto K, Hoshi N, Saita M, Yoneyama Y, Sato Y, Morokuma M, Okazaki J, Maeda T, Nakai K, Ichikawa T, Nagao K, Fujimoto K, Murata H, Kurogi T, Yoshida K, Nishimura M, Nishi Y, Murakami M, Hosoi T, Hamada T. Subjective Evaluation of Denture Adhesives: A Multicenter Randomized Controlled Trial. JDR Clin Trans Res. 2020 Jan;5(1):50-61. doi: 10.1177/2380084419837607. Epub 2019 Apr 11.
Results Reference
derived
PubMed Identifier
27756441
Citation
Kimoto S, Kawai Y, Gunji A, Kondo H, Nomura T, Murakami T, Tsuboi A, Hong G, Minakuchi S, Sato Y, Ohwada G, Suzuki T, Kimoto K, Hoshi N, Saita M, Yoneyama Y, Sato Y, Morokuma M, Okazaki J, Maeda T, Nakai K, Ichikawa T, Nagao K, Fujimoto K, Murata H, Kurogi T, Yoshida K, Nishimura M, Nishi Y, Murakami M, Hosoi T, Hamada T. Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial. Trials. 2016 Oct 18;17(1):506. doi: 10.1186/s13063-016-1612-x.
Results Reference
derived

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Multicenter Study of Denture Adhesive

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