Multicenter Study of Denture Adhesive

Not Applicable

Completed

• Conditions: Edentulous
• Interventions: Other: Saline

• Registration Number: NCT01712802
• Lead Sponsor: Nihon University

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).

Study Timeline

• Study First Submitted: 2012-10-17
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-24
• Study Start: 2012-12
• Primary Completion: 2017-02
• Status Verified: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• edentulous

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Saline	Parallel arm that receive placebo.

Primary Outcome Measures

Name	Time	Method
General satisfaction Patient reported outcomes	day 3 of adhesives application	General satisfaction (100mm visual analogue scale)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nihon University; 🇯🇵 Matsudo, Chiba, Japan