NCT01712802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

4.2 years

First QC Date

October 17, 2012

Last Update Submit

March 27, 2017

Conditions

Edentulous

Outcome Measures

Primary Outcomes (1)

  • General satisfaction Patient reported outcomes

    General satisfaction (100mm visual analogue scale)

    day 3 of adhesives application

Secondary Outcomes (4)

  • Moisture Objective outcomes

    day 3 of each adhesives application

  • masticatory function

    day 3 of each adhesives application

  • retentive force

    day 3 of each adhesives application

  • Oral related quality of life

    day 3 of adhesives application

Study Arms (3)

Denture Adhesives: Cream

EXPERIMENTAL

Parallel arm that receives application of Cream denture adhesives.

Other: Denture Adhesives: Cream

Denture Adhesives: Powder

EXPERIMENTAL

Parallel arm that receives application of powder denture adhesive.

Other: Denture Adhesives: Powder

control

PLACEBO COMPARATOR

Parallel arm that receive placebo.

Other: Saline

Interventions

Denture Adhesives: CreamOTHER

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

Also known as: Polident
Denture Adhesives: Cream
Denture Adhesives: PowderOTHER

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

Also known as: Poligrip powder
Denture Adhesives: Powder
SalineOTHER

work as control for Denture Adhesives: Cream and Powder

Also known as: Otsuka normal saline
control

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • edentulous

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nihon University

Matsudo, Chiba, 2718587, Japan

Location

Related Publications (2)

  • 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.

    PMID: 30975019DERIVED

  • 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.

    PMID: 27756441DERIVED

MeSH Terms

Conditions

Mouth, Edentulous

Interventions

PolidentSodium Chloride

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Yasuhiko Kawai, DDS MSc PhD

    Nihon University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 24, 2012

Study Start

December 1, 2012

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

JP(1)