Multicenter Study of Denture Adhesive (DAG)

Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline

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.

Study Overview

• Status: Completed
• Conditions: Edentulous
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Chiba
    • Matsudo, Chiba, Japan, 2718587
      • Nihon University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• edentulous

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: Poligrip powder
Placebo Comparator: control; Parallel arm that receive placebo.	Other: Saline; work as control for Denture Adhesives: Cream and Powder; Other Names: Otsuka normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General satisfaction Patient reported outcomes	General satisfaction (100mm visual analogue scale)	day 3 of adhesives application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moisture Objective outcomes	moisture(%)	day 3 of each adhesives application
masticatory function	Color change of chewing gum measured by color sensing machine (color scale: categorical)	day 3 of each adhesives application
retentive force	The maximum occlusal force that can bite before denture moves(N)	day 3 of each adhesives application
Oral related quality of life	Oral health impact profile (OHIP) edentulous Japanese version	day 3 of adhesives application

Collaborators and Investigators

• Sponsor: Nihon University
• Collaborators: Iwate Medical University; Tokyo Medical and Dental University; Hiroshima University; Nagasaki University; Tohoku University; University of Tokushima; Tsurumi University; Kanagawa Dental University Junior College; Osaka Dental University; Kagoshima University
• Investigators: Study Chair: Yasuhiko Kawai, DDS MSc PhD, Nihon University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: October 17, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (Estimate): October 24, 2012

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: KAKEN-24390439