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
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.
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.
Exclusion Criteria:
Test denture adhesive will be applied to participants' dentures via conventional pattern of application.
Device: Denture Adhesive Cream (Conventional Application)
Test denture adhesive will be applied to participants' dentures via continuous strips pattern of application.
Device: Denture Adhesive (Continuous Strip Application)
Participants will not apply any denture adhesive in this treatment arm.
Other: No Adhesive
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.
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.
No adhesive applied.
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
All the participants were recruited from one center in United States.
| Milestone | A-B-C | A-C-B | B-A-C | B-C-A | C-A-B | C-B-A |
|---|---|---|---|---|---|---|
| Started | 8 | 8 | 8 | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | A-B-C | A-C-B | B-A-C | B-C-A | C-A-B | C-B-A |
|---|---|---|---|---|---|---|
| Started | 8 | 8 | 8 | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | A-B-C | A-C-B | B-A-C | B-C-A | C-A-B | C-B-A |
|---|---|---|---|---|---|---|
| Started | 7 | 8 | 8 | 8 | 8 | 8 |
| Completed | 7 | 8 | 8 | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Grams | Conventional Application | Continuous Strip Application | No Adhesive |
|---|---|---|---|
| Mass of Peanuts Under Combined Maxillary and Mandibular Dentures (Denture Adhesive Applied Per Conventional Pattern) | 0.01184 ± 0.016237 | 0.00944 ± 0.013326 | 0.07853 ± 0.158567 |
Collected over 95 days. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Conventional Application | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| Continuous Strip Application | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
| No Adhesive | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
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(Years) | Overall |
|---|---|
| Mean | 65.0 ± 12.6 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 34 |
| Male | 14 |
| Race (NIH/OMB)(Participants) | Overall |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 44 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Current Lower Denture Age(Years) | Overall |
|---|---|
| Mean | 11.4 ± 12.31 |
| Current Upper Denture Age(Years) | Overall |
|---|---|
| Mean | 12.0 ± 12.25 |
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GlaxoSmithKline