Denture RetentionNCT02928380
Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress
A study testing Experimental Denture Adhesive and Reference (Marketed) Denture Adhesive in people with Denture Retention, run by GlaxoSmithKline at 1 site in United States.
Trial summary
In this clinical study, an experimental denture adhesive with a precision tip nozzle was tested to evaluate the relative efficacy to reduce the ingress of food under the denture compared to use of no adhesive or a standard marketed adhesive. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Denture Retention
- What is being tested?
- Experimental Denture Adhesive and Reference (Marketed) Denture Adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2016to 16 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Aged between 18 and 85 years inclusive
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general and mental health with, in the opinion of the investigator or medically qualified designee:No clinically significant and relevant abnormalities of medical or physical history; Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures
- A qualifying full denture in both the upper and lower arch
- Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability Index Sum Score ≥6)
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- Dentures are well made (according to the well-made assessment)
- Participants must report that they get food trapped under their denture
- A peanut particle migration rating >0 for both dentures at screening
Who cannot join
- Women who are known to be pregnant (participant-reported) or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Medications, which in the opinion of the investigator, would interfere with the conduct of the study
- Taking or have taken a bisphosphonate drug for treatment of osteoporosis
- A serious chronic disease requiring hospitalization
- History of swallowing difficulties or choking
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- Any condition not previously mentioned that in the investigator's opinion may impair the study evaluation
- Any condition or medication which, in the opinion of the investigator, is currently causing xerostomia
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Known allergy to peanuts or any other nut
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
- Recent history (within the last year) of alcohol or other substance abuse
- OST examination findings such as stomatitis, open sores, lesions, redness or swelling
- An employee of the sponsor or the study site or members of their immediate family
- Any participant who, in the opinion of the Investigator, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Ability of an Experimental Denture Adhesive to Prevent Food Particle Ingress Under Dentures
In this clinical study, an experimental denture adhesive with a precision tip nozzle was tested to evaluate the relative efficacy to reduce the ingress of food under the denture compared to use of no adhesive or a standard marketed adhesive.
Read the detailed description
The aim of this study is to explore the mass of food particle ingress when an adhesive is extruded through the new nozzle with directed application compared to the use of no adhesive and a marketed adhesive (extruded through a flat ribbon nozzle [FRN]) with standard application as per product label, utilizing a peanut occlusion methodology. This was a single center, controlled, single blind (to the examiner performing the safety assessments (oral soft tissue [OST] examination) and the laboratory staff weighing the peanut particles), randomized, three-treatment, three-period, cross-over design in participants with full upper and lower dentures. Each treatment period consisted of one day of testing with at least two days between treatment visits. This study consisted four visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit and Visit 4 - Treatment 3 Visit.
- Conditions
- Denture Retention
- Being tested
- Experimental Denture Adhesive, Reference (Marketed) Denture Adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Denture AdhesiveDevice
Participants received a single application of test denture adhesive with a Flat Ribbon Nozzle as 3 Continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture which were placed in the mouth.
Reference (Marketed) Denture AdhesiveDevice
Participants received a single application of marketed denture adhesive with a flat ribbon nozzle as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture, which were placed in the mouth.
| Study group | Role | What they receive |
|---|---|---|
| Reference Denture Adhesive | Active comparator | Participants applied reference denture adhesive as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth. Receives: Device: Reference (Marketed) Denture Adhesive |
| Test Denture Adhesive | Experimental | Participants applied test denture adhesive as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth. Receives: Device: Experimental Denture Adhesive |
| No Adhesive (Negative Control) | No intervention | Participants did not apply any denture adhesive in this treatment arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use
Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).
Measured: Up to 17 days
Secondary outcomes (5)
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and on no Adhesive Use
Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).
Measured: Up to 17 days
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and Reference Denture Adhesive
Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).
Measured: up to 17 days
Composite Kapur (Olshan Modification) Index Scores for Denture Retention and Stability
Kapur (Olshan modification) Index score was assessed to examine each denture (upper \& lower) for retention \& stability. Retention was measured as score of 0-5 to assess nature of resistance offered by denture to vertical pull \& lateral force: 5=Excellent;4=Very Good;3=Good;2=Fair;1= Poor;0=No retention. Stability was measured as score of 0-4 to assess nature of rocking offered by denture base on its supporting structures under pressure:4=Excellent (no rocking);3=Good (very slight rocking);2=Fair (slight rocking);1=Poor (moderate rocking);0=No stability (extreme rocking). Composite Kapur (Olshan modification) Index scores was measured as the sum score of retention \& stability for upper or lower dentures separately such that a sum score of zero represents no retention and stability and a sum score of 9 represents excellent retention and stability.
Measured: Up to 17 days
Kapur (Olshan Modification) Index Scores for Denture Retention
Kapur (Olshan modification) Index scores were assessed to examine each denture (upper \& lower) for its retention ability. Retention was measured as score of 0-5 to assess nature of resistance offered by denture to vertical pull \& lateral force: 5=Excellent - denture offered excellent resistance to vertical pull and lateral force; 4= Very Good- denture offered very good resistance to vertical pull and lateral force; 3= Good- denture offered moderate resistance to vertical pull and lateral force; 2= Fair- denture offered moderate resistance to vertical pull and little or no resistance to lateral forces; 1= Poor- denture offers slight resistance to vertical pull and little or no resistance to lateral force; 0= No retention- when the denture was seated in place, it displaced itself. Higher the score, higher the retention ability of denture.
Measured: Up to 17 days
Kapur (Olshan Modification) Index Scores for Denture Stability
Kapur (Olshan modification) Index scores were assessed to examine each denture (upper \& lower) for its stability ability. Stability was measured using score of 0-4: 4= Excellent- when denture base offered no rocking on its supporting structures under pressure; 3= Good- when denture base had very slight rocking on its supporting structures under pressure; 2= Fair- when denture base had slight rocking on its supporting structures under pressure; 1= Poor- when denture base had moderate rocking on its supporting structures under pressure; 0= No stability- when denture base had extreme rocking under pressure. Higher the score, higher the stability ability of denture.
Measured: Up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start25 Jul 2016
- Primary completion1 Sep 2016
- Study completion16 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Denture RetentionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928380
- Sponsor's protocol ID
- 205915
- Status last verified
- Jul 2018
- First submitted
- 18 Jul 2016
- Last updated
- 27 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Ability of an Experimental Denture Adhesive to Prevent Food Particle Ingress Under Dentures
- ClinicalTrials.gov ID
- NCT02928380
- Acronym / sponsor ID
- 205915
- Conditions
- Denture Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 16 Sep 2016 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Posted 6 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this clinical study, an experimental denture adhesive with a precision tip nozzle was tested to evaluate the relative efficacy to reduce the ingress of food under the denture compared to use of no adhesive or a standard marketed adhesive.
Detailed description
The aim of this study is to explore the mass of food particle ingress when an adhesive is extruded through the new nozzle with directed application compared to the use of no adhesive and a marketed adhesive (extruded through a flat ribbon nozzle [FRN]) with standard application as per product label, utilizing a peanut occlusion methodology. This was a single center, controlled, single blind (to the examiner performing the safety assessments (oral soft tissue [OST] examination) and the laboratory staff weighing the peanut particles), randomized, three-treatment, three-period, cross-over design in participants with full upper and lower dentures. Each treatment period consisted of one day of testing with at least two days between treatment visits. This study consisted four visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit and Visit 4 - Treatment 3 Visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference Denture Adhesive | Active comparator | Device: Reference (Marketed) Denture AdhesiveParticipants applied reference denture adhesive as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture which were placed in the mouth. |
| Test Denture Adhesive | Experimental | Device: Experimental Denture AdhesiveParticipants applied test denture adhesive as 3 continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture, which were placed in the mouth. |
| No Adhesive (Negative Control) | No intervention | –Participants did not apply any denture adhesive in this treatment arm. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Aged between 18 and 85 years inclusive
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general and mental health with, in the opinion of the investigator or medically qualified designee:No clinically significant and relevant abnormalities of medical or physical history; Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures
- A qualifying full denture in both the upper and lower arch
Key exclusion criteria (16 listed)
- Women who are known to be pregnant (participant-reported) or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Medications, which in the opinion of the investigator, would interfere with the conduct of the study
- Taking or have taken a bisphosphonate drug for treatment of osteoporosis
- A serious chronic disease requiring hospitalization
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 AdhesiveParticipants received a single application of test denture adhesive with a Flat Ribbon Nozzle as 3 Continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture which were placed in the mouth. | Device | Test Denture Adhesive |
| Reference (Marketed) Denture AdhesiveParticipants received a single application of marketed denture adhesive with a flat ribbon nozzle as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture, which were placed in the mouth. | Device | Reference Denture Adhesive |
Primary outcome
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use
Time frame: Up to 17 days
Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).
5 secondary outcomes
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and on no Adhesive Use
Time frame: Up to 17 days
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and Reference Denture Adhesive
Time frame: up to 17 days
Composite Kapur (Olshan Modification) Index Scores for Denture Retention and Stability
Time frame: Up to 17 days
Kapur (Olshan Modification) Index Scores for Denture Retention
Time frame: Up to 17 days
Kapur (Olshan Modification) Index Scores for Denture Stability
Time frame: Up to 17 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Reference (Marketed) Denture Adhesive in people with Denture Retention, run by GlaxoSmithKline 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 9 inclusion and 16 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 27 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 6 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use (time frame: Up to 17 days). 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 27 Aug 2018.