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Completed

NCT Number: NCT01712802

Multicenter Study of Denture Adhesive

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.

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Key information

Conditions

Edentulous Mouth Diseases Mouth, Edentulous Stomatognathic Diseases Tooth Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nihon University

Matsudo, Chiba, 2718587, Japan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • edentulous

Exclusion criteria

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

Treatment and study plan

Denture Adhesives: Cream

Other

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

Other names: Polident

Denture Adhesives: Powder

Other

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

Other names: Poligrip powder

Saline

Other

work as control for Denture Adhesives: Cream and Powder

Other names: Otsuka normal saline

Primary outcomes

  1. General satisfaction Patient reported outcomes

    Time frame: day 3 of adhesives application

    General satisfaction (100mm visual analogue scale)

Secondary outcomes

  1. Moisture Objective outcomes

    Time frame: day 3 of each adhesives application

    moisture(%)

  2. masticatory function

    Time frame: day 3 of each adhesives application

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

  3. retentive force

    Time frame: day 3 of each adhesives application

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

  4. Oral related quality of life

    Time frame: day 3 of adhesives application

    Oral health impact profile (OHIP) edentulous Japanese version

Sponsors and collaborators

Lead sponsor

Nihon University

Other

Collaborators

  • Hiroshima University
  • Iwate Medical University
  • Kagoshima University
  • Kanagawa Dental University Junior College
  • Nagasaki University
  • Osaka Dental University
  • Tohoku University
  • Tokyo Medical and Dental University
  • Tsurumi University
  • University of Tokushima

Registry information

Official study title

Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline

Acronym: DAG

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 24, 2012
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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