Trial Outcomes & Findings for A Study to Investigate Food Occlusion Efficacy of a Denture Adhesive in Denture Wearers (NCT NCT03709810)

Last Updated: 2020-03-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

49 participants

Primary outcome timeframe

Upto 16 days

Results posted on

2020-03-02

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Sequence 1 Participants received interventions in a crossover manner: A (experimental denture adhesive) in period 1, then intervention B (no adhesive) in period 2.	Sequence 2 Participants received interventions in a crossover manner: B (no adhesive) in period 1, then intervention A (experimental denture adhesive) in period 2.
Treatment Period 1 (Visit 2) STARTED	24	24
Treatment Period 1 (Visit 2) COMPLETED	24	24
Treatment Period 1 (Visit 2) NOT COMPLETED	0	0
Treatment Period 2 (Visit 3) STARTED	24	24
Treatment Period 2 (Visit 3) COMPLETED	24	24
Treatment Period 2 (Visit 3) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Investigate Food Occlusion Efficacy of a Denture Adhesive in Denture Wearers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=48 Participants Included participants randomized in both the treatment arms
Age, Continuous	65.1 Years STANDARD_DEVIATION 10.77 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Upto 16 days

Population: 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.

Outcome measures

Outcome measures
Measure	Experimental Denture Adhesive n=48 Participants 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.	No Adhesive n=48 Participants Participants did not receive any denture adhesive treatment randomized in this arm.
Food Occlusion Analysis of Combined Mass of Peanuts Under Combined Maxillary (Upper) and Mandibular (Lower) Dentures	5.56 Milligrams (mg) Interval 3.72 to 8.31	29.13 Milligrams (mg) Interval 19.48 to 43.56

SECONDARY outcome

Timeframe: Upto 16 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Experimental Denture Adhesive n=48 Participants 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.	No Adhesive n=48 Participants Participants did not receive any denture adhesive treatment randomized in this arm.
Food Occlusion Analysis of Mass of Peanuts Under Maxillary Denture	1.39 mg Interval 0.92 to 2.11	8.17 mg Interval 5.39 to 12.38

SECONDARY outcome

Timeframe: Upto 16 days

Outcome measures

Outcome measures
Measure	Experimental Denture Adhesive n=48 Participants 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.	No Adhesive n=48 Participants Participants did not receive any denture adhesive treatment randomized in this arm.
Food Occlusion Analysis of Mass of Peanuts Under Mandibular Denture	2.75 mg Interval 1.63 to 4.64	13.07 mg Interval 7.75 to 22.02

SECONDARY outcome

Timeframe: Upto 16 days

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.

Outcome measures

Outcome measures
Measure	Experimental Denture Adhesive n=48 Participants 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.	No Adhesive n=48 Participants Participants did not receive any denture adhesive treatment randomized in this arm.
Number of Denture Dislodgements During Chewing as Reported by Participants	0.0 Number of denture dislodgements Interval 0.0 to 10.0	4.0 Number of denture dislodgements Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: Upto 16 days

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.

Outcome measures

Outcome measures
Measure	Experimental Denture Adhesive n=48 Participants 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.	No Adhesive n=48 Participants Participants did not receive any denture adhesive treatment randomized in this arm.
Mean Scores From Participant Completed Questionnaire Amount of peanut pieces under denture	0.8 Score on scale Standard Error 0.29	3.8 Score on scale Standard Error 0.52
Mean Scores From Participant Completed Questionnaire Bothered by peanut pieces under denture	0.7 Score on scale Standard Error 0.28	4.0 Score on scale Standard Error 0.57

Adverse Events

Experimental Denture Adhesive

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

No Adhesive

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental Denture Adhesive n=48 participants at risk 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.	No Adhesive n=48 participants at risk Participants did not receive any denture adhesive treatment randomized in this arm.
Gastrointestinal disorders Oral hyperkeratosis	2.1% 1/48 • Number of events 1 • 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.	4.2% 2/48 • Number of events 2 • 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.
Injury, poisoning and procedural complications Mouth Injury	0.00% 0/48 • 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.	2.1% 1/48 • Number of events 1 • 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.
Injury, poisoning and procedural complications Traumatic ulcer	0.00% 0/48 • 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.	2.1% 1/48 • Number of events 1 • 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.
Nervous system disorders Tongue biting	2.1% 1/48 • Number of events 1 • 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.	0.00% 0/48 • 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.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER