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The purpose of this study is to determine the ability of a marketed denture adhesive to restrict food ingress underneath dentures during eating.
This is a single center, controlled, single-blind, randomized, two-treatment, two-period, cross-over design in participants with full upper and lower dentures. The study hypothesis is that this methodology will enable comparisons between denture adhesives and no adhesive to demonstrate the effectiveness of denture adhesives in restricting food ingress under dentures during eating. This study will consist of three visits: Visit 1 - Screening Visit; Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit. Participants will use test product which is a marketed denture adhesive (Super Poligrip Max Seal [SPMS]) (application will be controlled by weight) to the dentures in a pattern of continuous strips which will be applied to upper and lower denture and will be then placed in mouth and participants will also use no adhesive as a control. Participants will cross-over between treatments so that all participants will participate in all 2 treatment arms. An hour after the participant has worn their denture, they will chew a portion of peanuts in a controlled manner. After a rinsing procedure with water, the dentures will be removed, and any peanuts that have been migrated under each denture will be collected and weighed after a drying process. Participants will also answer a short questionnaire on the procedure and record the number of times their denture dislodged during the chewing procedure. The number of denture dislodgments reported by the participants during the chewing of the peanuts will also be collected and analyzed and this, and the questionnaire data, will be used to support the findings of the peanuts mass measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Denture Adhesive | Experimental | Test denture adhesive will be applied directly from the tubes using a continuous strip pattern to the upper and lower denture which will then be placed in mouth of the participants. |
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| Control | Other | Participants will not apply any denture adhesive in this treatment arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed Denture Adhesive (Super Poligrip Max Seal) | Combination Product | The denture adhesive will be applied directly from the tubes. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.1 g for the maxillary and 0.6±0.1g for the mandibular dentures. |
| Measure | Description | Time Frame |
|---|---|---|
| Food Occlusion Analysis of Combined Mass of Peanuts Under Combined Maxillary (Upper) and Mandibular (Lower) Dentures | On each test day(Visit2,3)participants underwent an Oral Soft Tissue (OST) exam,dentures cleaned using denture cleanser.Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After60+/-5minutes(min) of replacing denture in the mouth,participants consumed 30-32g of non-salted peanuts, divided into smaller portions of approximately(app) 8nut halves. Each portion was chewed for app20 seconds(sec). After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed,any nuts remaining in mouth were collected using gauze.Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min,water was strained by sieve.Collected nuts washed,air-dried and transferred to pre-weighed aluminium weighing pans,dried at 40-degree Celsius (deg C)for 5 hours(h). Pans removed,cooled to room temperature,weighed to determine mass of nuts collected from each denture. | Upto 16 days |
| Measure | Description | Time Frame |
|---|---|---|
| Food Occlusion Analysis of Mass of Peanuts Under Maxillary Denture | On each test day (Visit2,3) participants underwent an OST exam, dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5 min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app 8nut halves. Each portion was chewed for app20 sec. After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed, any nuts remaining in mouth were collected using gauze. Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min, water was strained by sieve. Collected nuts washed, air-dried and transferred to pre-weighed aluminium weighing pans, dried at 40-deg C for 5h. Pans removed, cooled to room temperature, weighed to determine mass of nuts collected from each denture. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fort Wayne | Indiana | 46825 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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Participants allocated to either intervention A(experimental test adhesive)or B(no adhesive)in period1. In period2,alternative sequence was assigned(B or A)in a crossover manner.Each period consisted of 1day testing(single use of experimental test product)with at least2days between adjacent treatment visits to recover from mastication procedures.
Participants were recruited from a single center in the United States. A total of 53 participants were screened, of which 49 were enrolled. 48 participants were randomized and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Participants received interventions in a crossover manner: A (experimental denture adhesive) in period 1, then intervention B (no adhesive) in period 2. |
| FG001 | Sequence 2 | Participants received interventions in a crossover manner: B (no adhesive) in period 1, then intervention A (experimental denture adhesive) in period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Visit 2) |
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| Treatment Period 2 (Visit 3) |
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Safety Population (N=48) included all randomized participants who received at least 1 dose of the study product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Included participants randomized in both the treatment arms |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Food Occlusion Analysis of Combined Mass of Peanuts Under Combined Maxillary (Upper) and Mandibular (Lower) Dentures | On each test day(Visit2,3)participants underwent an Oral Soft Tissue (OST) exam,dentures cleaned using denture cleanser.Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After60+/-5minutes(min) of replacing denture in the mouth,participants consumed 30-32g of non-salted peanuts, divided into smaller portions of approximately(app) 8nut halves. Each portion was chewed for app20 seconds(sec). After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed,any nuts remaining in mouth were collected using gauze.Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min,water was strained by sieve.Collected nuts washed,air-dried and transferred to pre-weighed aluminium weighing pans,dried at 40-degree Celsius (deg C)for 5 hours(h). Pans removed,cooled to room temperature,weighed to determine mass of nuts collected from each denture. | Efficacy analysis was performed on modified intent-to-treat (mITT) population [N=48] included all randomized participants who received at least 1 dose of the study product and had at least 1 on-therapy assessment of efficacy. | Posted | Geometric Mean | 95% Confidence Interval | Milligrams (mg) | Upto 16 days |
From signing of the informed consent form until 5 days after last administration of study drug (or last procedure)
Safety population: all randomized participants who received at least one dose of study medication. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Denture Adhesive | Participants randomized in this arm received 1.6 grams (g) of adhesive which was applied as 1.0 g (+/-0.1 g) on maxillary denture and 0.6 g (+/-0.1 g) on mandibular denture by dispensing staff. The adhesive was applied to upper and lower denture using a continuous strip pattern which was then placed in mouth for 60+/-5 min. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oral hyperkeratosis | Gastrointestinal disorders | MedDRA v21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 8, 2019 | Jan 21, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2019 | Jan 21, 2020 | SAP_001.pdf |
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| No Adhesive | Other | No adhesive will be applied. |
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| Upto 16 days |
| Food Occlusion Analysis of Mass of Peanuts Under Mandibular Denture | On each test day (Visit2,3) participants underwent an OST exam, dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5 min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app 8nut halves. Each portion was chewed for app20 sec. After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed, any nuts remaining in mouth were collected using gauze. Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min, water was strained by sieve. Collected nuts washed, air-dried and transferred to pre-weighed aluminium weighing pans, dried at 40-deg C for 5h. Pans removed, cooled to room temperature, weighed to determine mass of nuts collected from each denture. | Upto 16 days |
| Number of Denture Dislodgements During Chewing as Reported by Participants | On each test day (Visit 2,3) participants had an OST exam and their dentures were cleaned before study product was applied to the dentures. 1g (+/-) was applied to the upper denture and 0.6g (+/-) was applied to the lower dentures by dispensing staff. After insertion of the dentures into participants mouths, they were required to wait 60 mins (+/- 5mins) after which they were required to chew 30-32g of non-salted peanuts, divided into smaller portions of approximately 8 nut halves. Participants were required to chew each portion of peanuts for approximately 20 secs. Whilst consuming the peanuts, participants were required to tick a box every time they felt their denture dislodge. The total number of dislodgments were recorded by study site staff. | Upto 16 days |
| Mean Scores From Participant Completed Questionnaire | On each test day(Visit 2,3)participants underwent an OST exam,dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app8nut halves. Each portion chewed for app20 sec. After eating all,participants answered a questionnaire for chewing experience by questions (Q):Q1,were you aware of nuts pieces under your denture:yes/no.Participants answered no to Q1 were not required to answerQ2,3;they were automatically assigned 0 score for Q2,3. Participants who answered yes to Q1 were asked Q2,3;Q2,rate amount of nuts pieces under your denture on0-10scale;Q3,how bothered were you by nuts pieces went under your denture on0-10scale.Q2score:0=none,10=lots of nuts pieces;Q3score:0=not at all bothered,10=extremely bothered. Lower scores indicate better results. | Upto 16 days |
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| Secondary | Food Occlusion Analysis of Mass of Peanuts Under Maxillary Denture | On each test day (Visit2,3) participants underwent an OST exam, dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5 min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app 8nut halves. Each portion was chewed for app20 sec. After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed, any nuts remaining in mouth were collected using gauze. Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min, water was strained by sieve. Collected nuts washed, air-dried and transferred to pre-weighed aluminium weighing pans, dried at 40-deg C for 5h. Pans removed, cooled to room temperature, weighed to determine mass of nuts collected from each denture. | Efficacy analysis was performed on mITT population [N=48] included all randomized participants who received at least 1 dose of the study product and had at least 1 on-therapy assessment of efficacy. | Posted | Geometric Mean | 95% Confidence Interval | mg | Upto 16 days |
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| Secondary | Food Occlusion Analysis of Mass of Peanuts Under Mandibular Denture | On each test day (Visit2,3) participants underwent an OST exam, dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5 min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app 8nut halves. Each portion was chewed for app20 sec. After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed, any nuts remaining in mouth were collected using gauze. Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min, water was strained by sieve. Collected nuts washed, air-dried and transferred to pre-weighed aluminium weighing pans, dried at 40-deg C for 5h. Pans removed, cooled to room temperature, weighed to determine mass of nuts collected from each denture. | Efficacy analysis was performed on mITT population [N=48] included all randomized participants who received at least 1 dose of the study product and had at least 1 on-therapy assessment of efficacy. | Posted | Geometric Mean | 95% Confidence Interval | mg | Upto 16 days |
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| Secondary | Number of Denture Dislodgements During Chewing as Reported by Participants | On each test day (Visit 2,3) participants had an OST exam and their dentures were cleaned before study product was applied to the dentures. 1g (+/-) was applied to the upper denture and 0.6g (+/-) was applied to the lower dentures by dispensing staff. After insertion of the dentures into participants mouths, they were required to wait 60 mins (+/- 5mins) after which they were required to chew 30-32g of non-salted peanuts, divided into smaller portions of approximately 8 nut halves. Participants were required to chew each portion of peanuts for approximately 20 secs. Whilst consuming the peanuts, participants were required to tick a box every time they felt their denture dislodge. The total number of dislodgments were recorded by study site staff. | Efficacy analysis was performed on mITT population [N=48] included all randomized participants who received at least 1 dose of the study product and had at least 1 on-therapy assessment of efficacy. | Posted | Median | Full Range | Number of denture dislodgements | Upto 16 days |
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| Secondary | Mean Scores From Participant Completed Questionnaire | On each test day(Visit 2,3)participants underwent an OST exam,dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app8nut halves. Each portion chewed for app20 sec. After eating all,participants answered a questionnaire for chewing experience by questions (Q):Q1,were you aware of nuts pieces under your denture:yes/no.Participants answered no to Q1 were not required to answerQ2,3;they were automatically assigned 0 score for Q2,3. Participants who answered yes to Q1 were asked Q2,3;Q2,rate amount of nuts pieces under your denture on0-10scale;Q3,how bothered were you by nuts pieces went under your denture on0-10scale.Q2score:0=none,10=lots of nuts pieces;Q3score:0=not at all bothered,10=extremely bothered. Lower scores indicate better results. | Efficacy analysis was performed on mITT population [N=48] included all randomized participants who received at least 1 dose of the study product and had at least 1 on-therapy assessment of efficacy. | Posted | Mean | Standard Error | Score on scale | Upto 16 days |
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| 0 |
| 48 |
| 0 |
| 48 |
| 2 |
| 48 |
| EG001 | No Adhesive | Participants did not receive any denture adhesive treatment randomized in this arm. | 0 | 48 | 0 | 48 | 4 | 48 |
| Mouth Injury | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
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| Traumatic ulcer | Injury, poisoning and procedural complications | MedDRA v21.1 | Systematic Assessment |
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| Tongue biting | Nervous system disorders | MedDRA v21.1 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.