Partial DentureNCT05908890
A Study to Determine the Efficacy of a Denture Adhesive to Seal Out Food Particles From Under the Mandibular Partial Denture
A study testing Experimental Denture Adhesive and Fixodent True Feel Denture Adhesive in people with Partial Denture, run by Procter and Gamble at 1 site in United States.
Trial summary
The objective of this study is to evaluate the effectiveness of two denture adhesives at keeping food particles (seeds) from becoming trapped underneath partial denture(s). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partial Denture
- What is being tested?
- Experimental Denture Adhesive and Fixodent True Feel Denture Adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2019to 3 Oct 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- give written informed consent prior to their participation;
- be 18 years of age or older;
- have a Kennedy Class I or class II partial mandibular denture with a minimum of three consecutive teeth on the prosthesis;
- have a history of food particles getting under their partial, mandibular denture;
- agree not to use any denture adhesive on the day of their study visits, prior to the visit;
- agree to not participate in any other oral/dental product studies during the study;
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- be willing to use or not use denture adhesive as instructed during the treatment periods;
- be willing to eat a poppy seed muffin;
- be in good general health as determined by the Investigator/designee based on a review of the medical history/update; and
- have a minimum of 4 total poppy seeds on their mandibular denture base and gingiva after eating the muffin.
Who cannot join
- present with any disease or conditions that could be expected to interfere with examination procedures or the subject's safe completion of the study;
- self-report that they are allergic to denture adhesives or to the test food (gluten intolerance to muffin or intolerance to poppy seeds); or
- have appliances with intracorneal attachments, crowns with precision attachments or implant overdentures:
- have any condition or medication which, in the opinion of the investigator, is currently causing xerostomia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Determine the Efficacy of a Denture Adhesive Formulation to Seal Out Food Particles From Under the Mandibular Partial Denture
The objective of this study is to evaluate the effectiveness of two denture adhesives at keeping food particles (seeds) from becoming trapped underneath partial denture(s).
- Conditions
- Partial Denture
- Being tested
- Experimental Denture Adhesive, Fixodent True Feel Denture Adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Denture AdhesiveDevice
Adhesive will be applied to the partial denture(s) by a dental professional separate from the examiner and subject.
Fixodent True Feel Denture AdhesiveDevice
Adhesive will be applied to the partial denture(s) by a dental professional separate from the examiner and subject.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Denture Adhesive | Experimental | Not described Receives: Device: Experimental Denture Adhesive |
| Marketed Denture Adhesive | Active comparator | Not described Receives: Device: Fixodent True Feel Denture Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poppy Seed Count Before Treatment Application
Subjects ate 1/2 top of a poppy seed muffin. After eating the muffin, subjects were instructed to remove their partial mandibular denture and a dental professional counted the number of poppy seeds remaining on the subject's partial denture base and gingiva.
Measured: Immediately following consumption of the muffin before treatment application
Poppy Seed Count After Treatment Application
Subjects ate 1/2 top of a poppy seed muffin. After eating the muffin, subjects were instructed to remove their partial mandibular denture and a dental professional counted the number of poppy seeds remaining on the subject's partial denture base and gingiva.
Measured: Immediately following consumption of the muffin after treatment application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start8 Jul 2019
- Primary completion3 Oct 2019
- Study completion3 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial DentureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908890
- Sponsor's protocol ID
- 2018129
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Efficacy of a Denture Adhesive Formulation to Seal Out Food Particles From Under the Mandibular Partial Denture
- ClinicalTrials.gov ID
- NCT05908890
- Acronym / sponsor ID
- 2018129
- Conditions
- Partial Denture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 3 Oct 2019 (actual)
- First posted
- 18 Jun 2023 (actual)
- 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.
The objective of this study is to evaluate the effectiveness of two denture adhesives at keeping food particles (seeds) from becoming trapped underneath partial denture(s).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Denture Adhesive | Experimental | Device: Experimental Denture Adhesive |
| Marketed Denture Adhesive | Active comparator | Device: Fixodent True Feel Denture Adhesive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- give written informed consent prior to their participation;
- be 18 years of age or older;
- have a Kennedy Class I or class II partial mandibular denture with a minimum of three consecutive teeth on the prosthesis;
- have a history of food particles getting under their partial, mandibular denture;
- agree not to use any denture adhesive on the day of their study visits, prior to the visit;
Key exclusion criteria (4 listed)
- present with any disease or conditions that could be expected to interfere with examination procedures or the subject's safe completion of the study;
- self-report that they are allergic to denture adhesives or to the test food (gluten intolerance to muffin or intolerance to poppy seeds); or
- have appliances with intracorneal attachments, crowns with precision attachments or implant overdentures:
- have any condition or medication which, in the opinion of the investigator, is currently causing xerostomia.
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 |
|---|---|---|
| Experimental Denture AdhesiveAdhesive will be applied to the partial denture(s) by a dental professional separate from the examiner and subject. | Device | Experimental Denture Adhesive |
| Fixodent True Feel Denture AdhesiveAdhesive will be applied to the partial denture(s) by a dental professional separate from the examiner and subject. | Device | Marketed Denture Adhesive |
Primary outcome
Poppy Seed Count Before Treatment Application
Time frame: Immediately following consumption of the muffin before treatment application
Subjects ate 1/2 top of a poppy seed muffin. After eating the muffin, subjects were instructed to remove their partial mandibular denture and a dental professional counted the number of poppy seeds remaining on the subject's partial denture base and gingiva.
Poppy Seed Count After Treatment Application
Time frame: Immediately following consumption of the muffin after treatment application
Subjects ate 1/2 top of a poppy seed muffin. After eating the muffin, subjects were instructed to remove their partial mandibular denture and a dental professional counted the number of poppy seeds remaining on the subject's partial denture base and gingiva.
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 18 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Denture Adhesive and Fixodent True Feel Denture Adhesive in people with Partial Denture, run by Procter and Gamble at 1 site in United States.
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 10 inclusion and 4 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 18 Jun 2023. 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 United States. 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. 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?
Poppy Seed Count Before Treatment Application (time frame: Immediately following consumption of the muffin before treatment application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2023.