Trial Outcomes & Findings for Frequency of Denture Cleanser Use and Denture Cleanliness (NCT NCT02780661)

Last Updated: 2018-12-24

Results Overview

Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10-millimeter (mm) filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

Baseline (Day 0 pre-treatment), Day 7 (post-treatment)

Results posted on

2018-12-24

Participant Flow

All participants were recruited at a single center in United Kingdom.

A total of 25 participants were screened, out of which 19 participants were randomized to the study, 6 participants were not randomized because of screening failure.

Participant milestones

Participant milestones
Measure	Denture Cleanser Tablet: Daily Use /Weekly Use Participants were instructed to soak upper arch dentures in cup of very warm water (150 milliliter \[mL\]) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 minutes (min.) (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days) in treatment period 1. Following 7 day wash out period, same participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days); and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins in treatment period 2. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.	Denture Cleanser Tablet: Weekly Use/ Daily Use Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins in treatment period 1. Following 7 day wash out period, same participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 minutes (min.) (supervised product use at site: Day 0,3,7; home use of product in evening for rest of the days) in treatment period 1. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.
Period 1 STARTED	10	9
Period 1 COMPLETED	10	9
Period 1 NOT COMPLETED	0	0
Wash Out Period STARTED	10	9
Wash Out Period COMPLETED	10	9
Wash Out Period NOT COMPLETED	0	0
Period 2 STARTED	10	9
Period 2 COMPLETED	10	9
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Frequency of Denture Cleanser Use and Denture Cleanliness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomized Participants n=19 Participants All randomized participants were included for baseline evaluation.
Age, Continuous	68.7 years STANDARD_DEVIATION 5.10 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	19 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 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: Baseline (Day 0 pre-treatment), Day 7 (post-treatment)

Population: Analysis for this outcome was performed on intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of microbial count from disc sampling.

Outcome measures

Outcome measures
Measure	Denture Cleanser Tablet: Daily Use Period n=19 Participants Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.	Denture Cleanser Tablet: Weekly Use n=19 Participants Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.
Change From Baseline in Aerobic Bacteria Microbial Count on Day 7	-1.78 log10(CFU[colony forming unit]/disc+1) Standard Deviation 2.248	-1.20 log10(CFU[colony forming unit]/disc+1) Standard Deviation 2.636

PRIMARY outcome

Timeframe: Baseline (Day 0 pre-treatment), Day 7 (post-treatment)

Population: ITT Population defined as all participants who are randomized, received at least one dose of study treatment and have at least one post-baseline assessment of microbial count from disc sampling.

Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated anaerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.

Outcome measures

Outcome measures
Measure	Denture Cleanser Tablet: Daily Use Period n=19 Participants Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.	Denture Cleanser Tablet: Weekly Use n=19 Participants Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.
Change From Baseline in Anaerobic Bacteria Microbial Count on Day 7	-1.57 log10(CFU/disc+1) Standard Deviation 2.478	-1.54 log10(CFU/disc+1) Standard Deviation 2.586

PRIMARY outcome

Timeframe: Baseline (Day 0 pre-treatment), Day 7 (post-treatment)

Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.

Outcome measures

Outcome measures
Measure	Denture Cleanser Tablet: Daily Use Period n=19 Participants Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.	Denture Cleanser Tablet: Weekly Use n=19 Participants Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.
Change From Baseline in Candidal Microbial Count on Day 7	0.0 log10(CFU/disc+1) Standard Deviation 0.0	0.0 log10(CFU/disc+1) Standard Deviation 0.0

SECONDARY outcome

Timeframe: Baseline (Day 0 pre-treatment), Day 3 (post-treatment)

Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 3.

Outcome measures

Outcome measures
Measure	Denture Cleanser Tablet: Daily Use Period n=19 Participants Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.	Denture Cleanser Tablet: Weekly Use n=19 Participants Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.
Change From Baseline in Aerobic Bacteria Microbial Count on Day 3	-1.74 log10(CFU/disc+1) Standard Deviation 1.917	0.36 log10(CFU/disc+1) Standard Deviation 3.019

SECONDARY outcome

Timeframe: Baseline (Day 0 pre-treatment), Day 3 (post-treatment)

Outcome measures

Outcome measures
Measure	Denture Cleanser Tablet: Daily Use Period n=19 Participants Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.	Denture Cleanser Tablet: Weekly Use n=19 Participants Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.
Change From Baseline in Anaerobic Bacteria Microbial Count on Day 3	-1.74 log10(CFU/disc+1) Standard Deviation 2.134	1.08 log10(CFU/disc+1) Standard Deviation 2.753

SECONDARY outcome

Timeframe: Baseline (Day 0 pre-treatment), Day 3 (post-treatment)

Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 3.

Outcome measures

Outcome measures
Measure	Denture Cleanser Tablet: Daily Use Period n=19 Participants Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.	Denture Cleanser Tablet: Weekly Use n=19 Participants Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.
Change From Baseline in Candidal Microbial Count on Day 3	0.0 log10(CFU/disc+1) Standard Deviation 0.0	0.0 log10(CFU/disc+1) Standard Deviation 0.0

Adverse Events

Denture Cleanser Tablet: Daily Use

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Denture Cleanser Tablet: Weekly Use

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Measure	Denture Cleanser Tablet: Daily Use n=19 participants at risk Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) with 1 denture cleansing tablet from Day 0 to Day 7 for 15 min. (supervised product use at site: Day 0,3,7; home use of product in evening for rest of days). Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.	Denture Cleanser Tablet: Weekly Use n=19 participants at risk Participants were instructed to soak upper arch dentures in cup of very warm water (150 mL) from Day 0 to Day 6 for 15 mins (supervised product use at site: Day 0,3; home use of product in evening for rest of days) and in cup of very warm water (150 mL) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Participants were also instructed to brush dentures for 30 seconds using solution, rinse under running water for 10 seconds during each treatment period. Cleaning of upper arch dentures in morning was not permitted. Lower arch dentures were cleaned using participant's normal oral hygiene procedures in morning \& evening.
Gastrointestinal disorders Nausea	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Gastrointestinal disorders Oedema mouth	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Gastrointestinal disorders Oral mucosal erythema	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Gastrointestinal disorders Tongue coated	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Gastrointestinal disorders Stomatitis	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
General disorders Injury associated with device	21.1% 4/19 • Number of events 4 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	15.8% 3/19 • Number of events 4 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
General disorders Chronic fatigue syndrome	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Injury, poisoning and procedural complications Laceration	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Injury, poisoning and procedural complications Lip injury	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Injury, poisoning and procedural complications Post procedural complication	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Injury, poisoning and procedural complications Traumatic ulcer	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Injury, poisoning and procedural complications Mouth injury	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	15.8% 3/19 • Number of events 3 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Infections and infestations Diverticulitis	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Infections and infestations Oral herpes	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)
Eye disorders Eye pain	0.00% 0/19 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)	5.3% 1/19 • Number of events 1 • up to 31 days (from the start of denture and dental prophylaxis at the Screening Visit until 5 days following last administration of the study product at Visit 8)