Multicenter Study of Denture Adhesive

Nihon University200 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Edentulous

Interventions

Denture Adhesives: CreamOTHER

Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.

Denture Adhesives: PowderOTHER

Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.

SalineOTHER

work as control for Denture Adhesives: Cream and Powder

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * edentulous Exclusion Criteria: * Cannot answer the questionnaire * Deteriorating general conditions * Maxillofacial defect * Metal denture user * Already denture adhesive users * Severe xerostomia

Locations (1)

Nihon University

Matsudo, Chiba, Japan

Outcomes

Primary Outcomes

General satisfaction Patient reported outcomes

General satisfaction (100mm visual analogue scale)

Time frame: day 3 of adhesives application

Secondary Outcomes

Moisture Objective outcomes

moisture(%)

Time frame: day 3 of each adhesives application

masticatory function

Color change of chewing gum measured by color sensing machine (color scale: categorical)

Time frame: day 3 of each adhesives application

retentive force

The maximum occlusal force that can bite before denture moves(N)

Time frame: day 3 of each adhesives application

Oral related quality of life

Oral health impact profile (OHIP) edentulous Japanese version

Time frame: day 3 of adhesives application

Data from ClinicalTrials.gov

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