Multicenter Study of Denture Adhesive

NCT ID: NCT01712802

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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).

Conditions

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Edentulous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Denture Adhesives: Cream

Parallel arm that receives application of Cream denture adhesives.

Group Type EXPERIMENTAL

Denture Adhesives: Cream

Intervention Type OTHER

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

Denture Adhesives: Powder

Parallel arm that receives application of powder denture adhesive.

Group Type EXPERIMENTAL

Denture Adhesives: Powder

Intervention Type OTHER

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

control

Parallel arm that receive placebo.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

work as control for Denture Adhesives: Cream and Powder

Interventions

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Denture Adhesives: Cream

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

Intervention Type OTHER

Denture Adhesives: Powder

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

Intervention Type OTHER

Saline

work as control for Denture Adhesives: Cream and Powder

Intervention Type OTHER

Other Intervention Names

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Polident Poligrip powder Otsuka normal saline

Eligibility Criteria

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Inclusion Criteria

* edentulous

Exclusion Criteria

* Cannot answer the questionnaire
* Deteriorating general conditions
* Maxillofacial defect
* Metal denture user
* Already denture adhesive users
* Severe xerostomia
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iwate Medical University

OTHER

Sponsor Role collaborator

Tohoku University

OTHER

Sponsor Role collaborator

Tsurumi University

OTHER

Sponsor Role collaborator

Kanagawa Dental University Junior College

OTHER

Sponsor Role collaborator

Tokyo Medical and Dental University

OTHER

Sponsor Role collaborator

Osaka Dental University

UNKNOWN

Sponsor Role collaborator

Hiroshima University

OTHER

Sponsor Role collaborator

University of Tokushima

OTHER

Sponsor Role collaborator

Nagasaki University

OTHER

Sponsor Role collaborator

Kagoshima University

OTHER

Sponsor Role collaborator

Nihon University

OTHER

Sponsor Role lead

Responsible Party

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Yasuhiko Kawai

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasuhiko Kawai, DDS MSc PhD

Role: STUDY_CHAIR

Nihon University

Locations

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Nihon University

Matsudo, Chiba, Japan

Site Status

Countries

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Japan

References

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Ohwada G, Minakuchi S, Sato Y, Kondo H, Nomura T, Tsuboi A, Hong G, Itoh Y, Kawai Y, Kimoto S, Gunji A, Suzuki A, Suzuki T, Kimoto K, Hoshi N, Saita M, Yoneyama Y, Sato Y, Morokuma M, Okazaki J, Maeda T, Nakai K, Ichikawa T, Nagao K, Fujimoto K, Murata H, Kurogi T, Yoshida K, Nishimura M, Nishi Y, Murakami M, Hosoi T, Hamada T. Subjective Evaluation of Denture Adhesives: A Multicenter Randomized Controlled Trial. JDR Clin Trans Res. 2020 Jan;5(1):50-61. doi: 10.1177/2380084419837607. Epub 2019 Apr 11.

Reference Type DERIVED
PMID: 30975019 (View on PubMed)

Kimoto S, Kawai Y, Gunji A, Kondo H, Nomura T, Murakami T, Tsuboi A, Hong G, Minakuchi S, Sato Y, Ohwada G, Suzuki T, Kimoto K, Hoshi N, Saita M, Yoneyama Y, Sato Y, Morokuma M, Okazaki J, Maeda T, Nakai K, Ichikawa T, Nagao K, Fujimoto K, Murata H, Kurogi T, Yoshida K, Nishimura M, Nishi Y, Murakami M, Hosoi T, Hamada T. Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial. Trials. 2016 Oct 18;17(1):506. doi: 10.1186/s13063-016-1612-x.

Reference Type DERIVED
PMID: 27756441 (View on PubMed)

Other Identifiers

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KAKEN-24390439

Identifier Type: -

Identifier Source: org_study_id

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