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CompletedNCT03345108Updated Mar 29, 2019Results posted

A Study to Investigate a Method to Measure Food Occlusion by Denture Adhesives in Denture Wearers

An interventional study of Denture Adhesive Cream (Conventional Application) and Denture Adhesive (Continuous Strip Application) 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 2019-03-29.

Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate a methodology to determine the ability of a denture adhesive to restrict food ingress underneath dentures during eating.

Read the detailed description

This will be a single centre, controlled, open label, randomized, three-treatment, three-period, cross-over design in participants with full upper and full lower dentures. Each treatment period will consist of one day of testing with at least two days between adjacent treatment visits. This study will consist of four visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit and Visit 4 - Treatment 3 Visit. (Participants will use Test product (denture adhesive) applied to the dentures either in a pattern consistent with standard application or applied to the dentures in a pattern of continuous strips. Participants will also use no adhesive as a control. Participants will cross-over between treatments so that all participants will participate in all 3 treatment arms. An hour after the participant has worn their denture, they will chew a portion of peanuts in a controlled manner. The peanuts that migrate under the denture during this chewing procedure will be collected, washed, dried and weighed. Participant will also answer a short questionnaire on the procedure and record the number of times their denture dislodged during the chewing procedure. The study hypothesis is that this methodology will enable comparisons between denture adhesives and no adhesive to demonstrate the effectiveness of denture adhesives at restricting food ingress under dentures during eating.

02

Conditions studied

  • Denture Retention
03

Who can participate

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

Inclusion criteria

  • Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • Male or female who, at the time of screening, are between the ages of 18 and 85 years, inclusive.
  • Willing and able to comply with scheduled visits, treatment plan, and other study procedures.
  • Healthy, defined as in general good physical health, as judged by the investigator.
  • Self-reports experience of getting food trapped under their denture.
  • Is an habitual wearer of both of their dentures defined as participants who wear both of their dentures for the majority of their time whilst awake.
  • Females of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 1 day after the last dose of assigned treatment.
  • Female participants who are not of childbearing potential must meet following requirements: a) Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle stimulating hormone (FSH) level confirming the post-menopausal state, b) Have undergone a documented hysterectomy and/or bilateral oophorectomy, and have medically confirmed ovarian failure.
  • Have denture prostheses that fulfil all of the following: a) A qualifying conventional acrylic full denture in both the upper and lower arch, b) Dentures are well fitting (Kapur (Olshan Modification) Retention and Stability Index Sum Score ≥6) (Olshan, 1992) with no individual stability or retention scores \<1, c) Dentures are well made (according to the well-made assessment), and d) Has a peanut particle migration rating >0 for each denture.

Exclusion criteria

Exclusion Criteria:

  • An investigational site staff member directly involved in the conduct of the study or their family member, site staff members otherwise supervised by the investigator, or an employee of the sponsor directly involved in the conduct of the study.
  • Participation in any other clinical study involving investigational drugs, cosmetics or medical devices within 30 days prior to study entry and/or during study participation.
  • Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Pregnant female participants.
  • Breastfeeding female participants.
  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
  • History of swallowing difficulties or choking.
  • Currently taking or have taken a bisphosphonate drug (i.e., Fosamax®, Actonel®, Boniva®) for treatment of osteoporosis.
  • Any clinically significant or relevant oral abnormality (e.g. temporomandibular joint [TMJ] problems) that, in the opinion of the investigator, could affect the participants participation in the study.
  • Known allergy to peanuts or any other nut.
  • Any condition or medication which, in the opinion of the investigator, is currently causing xerostomia.
  • Recent history (within the last year) of alcohol or other substance abuse.
  • OST examination findings such as stomatitis, open sores, lesions, redness or swelling which in the opinion of the investigator, would interfere with the conduct of the study.
  • Use of any medication that, in the opinion of the investigator, would interfere with the conduct of the study.
  • A serious chronic disease requiring intermittent hospital visits.
  • Having been previously enrolled in this study.
  • Any participant who, in the opinion of the investigator, should not participate in the study.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Test Denture Adhesive (Conventional Application)

    Test denture adhesive will be applied to participants' dentures via conventional pattern of application.

    Device: Denture Adhesive Cream (Conventional Application)

  • Experimental
    Test Denture Adhesive (Continuous strip Application)

    Test denture adhesive will be applied to participants' dentures via continuous strips pattern of application.

    Device: Denture Adhesive (Continuous Strip Application)

  • Other
    Negative Control

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

    Other: No Adhesive

Interventions

  • DeviceDenture Adhesive Cream (Conventional Application)

    The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05g for the maxillary and 0.60±0.05g for the mandibular dentures.

  • DeviceDenture Adhesive (Continuous Strip Application)

    The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05 g for the maxillary and 0.60±0.05 g for the mandibular dentures.

  • OtherNo Adhesive

    No adhesive applied.

05

What researchers measure

Primary outcomes

  1. Mass of Peanuts Under Combined Maxillary and Mandibular Dentures (Denture Adhesive Applied Per Conventional Pattern)

    Participants received 1.6 grams (g) of test adhesive on their dentures in a conventional pattern. After 60 minutes (min), participants were provided with 30-32 g non-salted peanuts, divided into smaller portions of approximately eight peanut halves. Each portion chewed for approximately 20 seconds (s). After consumption of all peanuts, participants had rinse their mouth with water for approximately 5 s. Dentures were removed and any peanuts remaining in the mouth were collected using a gauze. Both denture and gauze were placed in a beaker with hot de-ionized water and sonicated for 30 minutes (min) after which the water was strained through a standard testing sieve. The collected particles were washed and air-dried and transferred to pre-weighed aluminium weighing pans using a spatula and then, were dried in an oven at 40-degree Celsius for 5 hours. The pans were removed, cooled to room temperature and then weighed to determine the mass of the particles collected from each denture.

    Time frame: Upto 9 weeks

06

Results

Posted Mar 29, 2019

Participant flow

All the participants were recruited from one center in United States.

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Participant flow — Period-1
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Participant flow — Period-2
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Participant flow — Period-3
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Outcome measures

PrimaryMass of Peanuts Under Combined Maxillary and Mandibular Dentures (Denture Adhesive Applied Per Conventional Pattern)

Participants received 1.6 grams (g) of test adhesive on their dentures in a conventional pattern. After 60 minutes (min), participants were provided with 30-32 g non-salted peanuts, divided into smaller portions of approximately eight peanut halves. Each portion chewed for approximately 20 seconds (s). After consumption of all peanuts, participants had rinse their mouth with water for approximately 5 s. Dentures were removed and any peanuts remaining in the mouth were collected using a gauze. Both denture and gauze were placed in a beaker with hot de-ionized water and sonicated for 30 minutes (min) after which the water was strained through a standard testing sieve. The collected particles were washed and air-dried and transferred to pre-weighed aluminium weighing pans using a spatula and then, were dried in an oven at 40-degree Celsius for 5 hours. The pans were removed, cooled to room temperature and then weighed to determine the mass of the particles collected from each denture.

Time frame:
Upto 9 weeks
Reported as:
Mean · Grams
Mass of Peanuts Under Combined Maxillary and Mandibular Dentures (Denture Adhesive Applied Per Conventional Pattern)
GramsConventional ApplicationContinuous Strip ApplicationNo Adhesive
Mass of Peanuts Under Combined Maxillary and Mandibular Dentures (Denture Adhesive Applied Per Conventional Pattern)0.01184 ± 0.0162370.00944 ± 0.0133260.07853 ± 0.158567

Adverse events

Collected over 95 days. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Conventional Application0/48 (0%)0/48 (0%)0/48 (0%)
Continuous Strip Application0/48 (0%)0/48 (0%)0/48 (0%)
No Adhesive0/47 (0%)0/47 (0%)0/47 (0%)

Baseline characteristics

47 participants started the no adhesive treatment period, since 1 participant discontinued the study after completing period 2 and therefore did not return for treatment period 3 of no adhesive. The demographic and baseline characteristics has been reported for intent-to-treat (ITT) population (N=48).

Age, Continuous
Age, Continuous(Years)Overall
Mean65.0 ± 12.6
Sex: Female, Male
Sex: Female, Male(Participants)Overall
Female34
Male14
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Overall
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American4
White44
More than one race0
Unknown or Not Reported0
Current Lower Denture Age
Current Lower Denture Age(Years)Overall
Mean11.4 ± 12.31
Current Upper Denture Age
Current Upper Denture Age(Years)Overall
Mean12.0 ± 12.25
07

Study locations

1 site
  • GSK Investigational Site
    Fort Wayne, Indiana 46825, United States
08

References and documents

Study documents

  • Study protocol · Oct 24, 2017
  • Statistical analysis plan · Dec 14, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03345108
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Nov 17, 2017
Start date
Nov 20, 2017
Primary completion
Dec 15, 2017
Completion
Dec 15, 2017
Results posted
Mar 29, 2019
Last update
Mar 29, 2019

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
GSK Clinical Trials
study director · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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