EdentulousDAGNCT01712802
Multicenter Study of Denture Adhesive
A study testing Denture Adhesives: Cream, Denture Adhesives: Powder and Saline in people with Edentulous, run by Nihon University at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous
- What is being tested?
- Denture Adhesives: Cream, Denture Adhesives: Powder and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2012to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- edentulous
Who cannot join
- Cannot answer the questionnaire
- Deteriorating general conditions
- Maxillofacial defect
- Metal denture user
- Already denture adhesive users
- Severe xerostomia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline
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.
Read the 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).
- Conditions
- Edentulous
- Being tested
- Denture Adhesives: Cream, Denture Adhesives: Powder, Saline
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denture Adhesives: CreamOther
Also called Polident
Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.
Denture Adhesives: PowderOther
Also called Poligrip powder
Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.
SalineOther
Also called Otsuka normal saline
work as control for Denture Adhesives: Cream and Powder
| Study group | Role | What they receive |
|---|---|---|
| Denture Adhesives: Cream | Experimental | Parallel arm that receives application of Cream denture adhesives. Receives: Other: Denture Adhesives: Cream |
| Denture Adhesives: Powder | Experimental | Parallel arm that receives application of powder denture adhesive. Receives: Other: Denture Adhesives: Powder |
| control | Placebo comparator | Parallel arm that receive placebo. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
General satisfaction Patient reported outcomes
General satisfaction (100mm visual analogue scale)
Measured: day 3 of adhesives application
Secondary outcomes (4)
Moisture Objective outcomes
moisture(%)
Measured: day 3 of each adhesives application
masticatory function
Color change of chewing gum measured by color sensing machine (color scale: categorical)
Measured: day 3 of each adhesives application
retentive force
The maximum occlusal force that can bite before denture moves(N)
Measured: day 3 of each adhesives application
Oral related quality of life
Oral health impact profile (OHIP) edentulous Japanese version
Measured: day 3 of adhesives application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EdentulousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon University
- Sponsor type
- University, hospital or other
- Collaborators
- Iwate Medical University, Tohoku University, Tsurumi University, Kanagawa Dental University Junior College, Tokyo Medical and Dental University, Osaka Dental University, Hiroshima University, University of Tokushima, Nagasaki University, Kagoshima University
- Responsible party
- Principal investigator, Yasuhiko Kawai, Nihon University
- Investigators
- Yasuhiko Kawai, DDS MSc PhD, Study chair, Nihon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712802
- Sponsor's protocol ID
- KAKEN-24390439
- Acronym
- DAG
- Status last verified
- Mar 2017
- First submitted
- 17 Oct 2012
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30975019Kimoto 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.
PubMed 27756441
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline
- ClinicalTrials.gov ID
- NCT01712802
- Acronym / sponsor ID
- DAG / KAKEN-24390439
- Conditions
- Edentulous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nihon UniversityUniversity, hospital or other
- Collaborators
- Iwate Medical University, Tohoku University, Tsurumi University, Kanagawa Dental University Junior College, Tokyo Medical and Dental University, Osaka Dental University, Hiroshima University, University of Tokushima, Nagasaki University, Kagoshima University
- Study start
- Dec 2012 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 24 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Denture Adhesives: Cream | Experimental | Other: Denture Adhesives: CreamParallel arm that receives application of Cream denture adhesives. |
| Denture Adhesives: Powder | Experimental | Other: Denture Adhesives: PowderParallel arm that receives application of powder denture adhesive. |
| control | Placebo comparator | Other: SalineParallel arm that receive placebo. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- edentulous
Key exclusion criteria (6 listed)
- Cannot answer the questionnaire
- Deteriorating general conditions
- Maxillofacial defect
- Metal denture user
- Already denture adhesive users
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denture Adhesives: CreamAlso: PolidentUsing Polident as denture adhesive to compare its effect on PRO and subjective outcomes. | Other | Denture Adhesives: Cream |
| Denture Adhesives: PowderAlso: Poligrip powderUsing Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes. | Other | Denture Adhesives: Powder |
| SalineAlso: Otsuka normal salinework as control for Denture Adhesives: Cream and Powder | Other | control |
Primary outcome
General satisfaction Patient reported outcomes
Time frame: day 3 of adhesives application
General satisfaction (100mm visual analogue scale)
4 secondary outcomes
Moisture Objective outcomes
Time frame: day 3 of each adhesives application
masticatory function
Time frame: day 3 of each adhesives application
retentive force
Time frame: day 3 of each adhesives application
Oral related quality of life
Time frame: day 3 of adhesives application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Derived from this study: PubMed 30975019Ohwada 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.
- Derived from this study: PubMed 27756441Kimoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasuhiko Kawai, DDS MSc PhD study chair
Nihon University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Denture Adhesives: Cream, Denture Adhesives: Powder and Saline in people with Edentulous, run by Nihon University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General satisfaction Patient reported outcomes (time frame: day 3 of adhesives application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01712802, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.