Multicenter Study of Denture Adhesive (DAG)

Nihon University

Status: Completed

Conditions: Edentulous

Treatments: Other: Denture Adhesives: Powder; Other: Denture Adhesives: Cream; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01712802

KAKEN-24390439

Details and patient eligibility

About

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 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).

Enrollment: 200 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 3 patient groups, including a placebo group

Denture Adhesives: Cream

Experimental group

Description:

Parallel arm that receives application of Cream denture adhesives.

Treatment:

Other: Denture Adhesives: Cream

Denture Adhesives: Powder

Experimental group

Description:

Parallel arm that receives application of powder denture adhesive.

Treatment:

Other: Denture Adhesives: Powder

control

Placebo Comparator group

Description:

Parallel arm that receive placebo.

Treatment:

Other: Saline