Multicenter Study of Denture Adhesive

Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01712802

Acronym

DAG

Enrollment

200

Registered

2012-10-24

Start date

2012-12-31

Completion date

2017-03-31

Last updated

2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous

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).

Interventions

OTHERDenture Adhesives: Cream

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

OTHERDenture Adhesives: Powder

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

OTHERSaline

work as control for Denture Adhesives: Cream and Powder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026