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CompletedNCT02928380Updated Aug 27, 2018Results posted

Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress

An interventional study of Experimental Denture Adhesive and Reference (Marketed) Denture Adhesive in Denture Retention, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-27.

Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Denture Retention
03

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
83 participants (actual)

Study arms

  • Active comparator
    Reference Denture Adhesive

    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.

    Device: Reference (Marketed) Denture Adhesive

  • Experimental
    Test Denture Adhesive

    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.

    Device: Experimental Denture Adhesive

  • No intervention
    No Adhesive (Negative Control)

    Participants did not apply any denture adhesive in this treatment arm.

Interventions

  • DeviceExperimental Denture Adhesive

    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.

  • DeviceReference (Marketed) Denture Adhesive

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Up to 17 days

Secondary outcomes

  1. 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).

    Time frame: Up to 17 days

  2. 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).

    Time frame: up to 17 days

  3. 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.

    Time frame: Up to 17 days

  4. 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.

    Time frame: Up to 17 days

  5. 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.

    Time frame: Up to 17 days

07

Results

Posted Dec 6, 2017

Participant flow

Participants were recruited at a single center in the United States.

Period 1
Participant flow — Period 1
MilestoneReference Denture Adhesive/Test Denture Adhesive/No AdhesiveReference Denture Adhesive/No Adhesive/Test Denture AdhesiveTest Denture Adhesive/Reference Denture Adhesive/No AdhesiveTest Denture Adhesive/No Adhesive/Reference Denture AdhesiveNo Adhesive/Reference Denture Adhesive/Test Denture AdhesiveNo Adhesive/Test Denture Adhesive/Reference Denture Adhesive
Started131414141414
Completed131414141414
Not completed000000
Wash Out Period 1
Participant flow — Wash Out Period 1
MilestoneReference Denture Adhesive/Test Denture Adhesive/No AdhesiveReference Denture Adhesive/No Adhesive/Test Denture AdhesiveTest Denture Adhesive/Reference Denture Adhesive/No AdhesiveTest Denture Adhesive/No Adhesive/Reference Denture AdhesiveNo Adhesive/Reference Denture Adhesive/Test Denture AdhesiveNo Adhesive/Test Denture Adhesive/Reference Denture Adhesive
Started131414141414
Completed131414141414
Not completed000000
Period 2
Participant flow — Period 2
MilestoneReference Denture Adhesive/Test Denture Adhesive/No AdhesiveReference Denture Adhesive/No Adhesive/Test Denture AdhesiveTest Denture Adhesive/Reference Denture Adhesive/No AdhesiveTest Denture Adhesive/No Adhesive/Reference Denture AdhesiveNo Adhesive/Reference Denture Adhesive/Test Denture AdhesiveNo Adhesive/Test Denture Adhesive/Reference Denture Adhesive
Started131414141414
Completed131414141414
Not completed000000
Wash Out Period 2
Participant flow — Wash Out Period 2
MilestoneReference Denture Adhesive/Test Denture Adhesive/No AdhesiveReference Denture Adhesive/No Adhesive/Test Denture AdhesiveTest Denture Adhesive/Reference Denture Adhesive/No AdhesiveTest Denture Adhesive/No Adhesive/Reference Denture AdhesiveNo Adhesive/Reference Denture Adhesive/Test Denture AdhesiveNo Adhesive/Test Denture Adhesive/Reference Denture Adhesive
Started131414141414
Completed131414141414
Not completed000000
Period 3
Participant flow — Period 3
MilestoneReference Denture Adhesive/Test Denture Adhesive/No AdhesiveReference Denture Adhesive/No Adhesive/Test Denture AdhesiveTest Denture Adhesive/Reference Denture Adhesive/No AdhesiveTest Denture Adhesive/No Adhesive/Reference Denture AdhesiveNo Adhesive/Reference Denture Adhesive/Test Denture AdhesiveNo Adhesive/Test Denture Adhesive/Reference Denture Adhesive
Started131414141414
Completed131414141414
Not completed000000

Outcome measures

PrimaryCombined 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).

Time frame:
Up to 17 days
Reported as:
Mean · gram (g)
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use
gram (g)Reference Denture AdhesiveNo Adhesive (Negative Control)
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use0.06 ± 0.0570.08 ± 0.151
Statistical analysis
  • Reference Denture Adhesive vs No Adhesive (Negative Control) · ANOVA · p = 0.0987 · Least square (ls) mean difference: -0.02 · 95% CI -0.05 to 0.00Difference is first named treatment minus second named treatment is such that a negative difference favors the first named treatment.
SecondaryCombined 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).

Time frame:
Up to 17 days
Reported as:
Mean · g
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and on no Adhesive Use
gTest Denture AdhesiveNo Adhesive (Negative Control)
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and on no Adhesive Use0.07 ± 0.0920.08 ± 0.151
SecondaryCombined 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).

Time frame:
up to 17 days
Reported as:
Mean · g
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and Reference Denture Adhesive
gTest Denture AdhesiveReference Denture Adhesive
Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and Reference Denture Adhesive0.07 ± 0.0920.06 ± 0.057
SecondaryComposite 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.

Time frame:
Up to 17 days
Reported as:
Mean · scores on a scale
Composite Kapur (Olshan Modification) Index Scores for Denture Retention and Stability
scores on a scaleReference Denture AdhesiveTest Denture AdhesiveNo Adhesive (Negative Control)
For Upper Denture8.67 ± 0.8288.84 ± 0.5948.35 ± 1.224
For Lower Denture7.42 ± 1.8158.11 ± 1.5936.36 ± 1.535
SecondaryKapur (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.

Time frame:
Up to 17 days
Reported as:
Mean · scores on a scale
Kapur (Olshan Modification) Index Scores for Denture Retention
scores on a scaleReference Denture AdhesiveTest Denture AdhesiveNo Adhesive (Negative Control)
For Upper Denture4.80 ± 0.5124.90 ± 0.3354.63 ± 0.728
For Lower Denture4.05 ± 1.0704.43 ± 0.9403.46 ± 0.874
SecondaryKapur (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.

Time frame:
Up to 17 days
Reported as:
Mean · scores on a scale
Kapur (Olshan Modification) Index Scores for Denture Stability
scores on a scaleReference Denture AdhesiveTest Denture AdhesiveNo Adhesive (Negative Control)
For Upper Denture3.88 ± 0.3633.94 ± 0.2863.72 ± 0.570
For Lower Denture3.37 ± 0.8073.67 ± 0.7002.90 ± 0.775

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Reference Denture Adhesive0/83 (0%)0/83 (0%)0/83 (0%)
Test Denture Adhesive0/83 (0%)0/83 (0%)0/83 (0%)
No Adhesive (Negative Control)0/83 (0%)0/83 (0%)0/83 (0%)

Baseline characteristics

Baseline analysis was performed on Intention to treat (ITT) population which included all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.

Age, Continuous
Age, Continuous(Years)Overall Participants
Mean63.4 ± 12.99
Sex: Female, Male
Sex: Female, Male(Participants)Overall Participants
Female62
Male21
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Overall Participants
Hispanic or Latino1
Not Hispanic or Latino82
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Overall Participants
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander1
Black or African American12
White70
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • GSK Investigational Site
    Fort Wayne, Indiana 46825, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02928380
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 10, 2016
Start date
Jul 25, 2016
Primary completion
Sep 1, 2016
Completion
Sep 16, 2016
Results posted
Dec 6, 2017
Last update
Aug 27, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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