Denture Cleansers
Conditions
Brief summary
This method development study will be a two treatment arm, randomized, cross over study in a population with edentulous upper arch restored with a maxillary complete denture. The lower may be a partial or full edentulous mandibular arch that may be restored with a stable complete, partial or implant supported denture.
Detailed description
This is a single-center, 2 treatment periods, examiner-blind, randomized, 7 day crossover study in adult participants with a complete maxillary denture. This is a method development study to investigate the changes in the level of denture plaque, microbial counts, microbial composition and stain on the maxillary dentures after daily denture cleanser use versus dentures that are cleaned weekly.
Interventions
DEVICEDenture Cleanser Daily Use Period
One denture cleansing tablet will be soaked in a cup of very warm water (150 ml) with dentures for Day 0 to Day 7 for 15 mins. Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds.
DEVICEDenture Cleanser Weekly Use Period
One denture cleansing tablet will be soaked in cup of very warm water (150 ml) from Day 0 to Day 6 for 15 mins; and in cup of very warm water (150 ml) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds.
OTHERWater
A cup of very warm water will be used to soak one denture cleansing tablet and dentures for per day (Day 0 to Day 7) or weekly (Day 0 and Day 7) treatment regimen.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Aged between 18 and 84 years inclusive. * Good general and mental health with, in the opinion of the Investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon oral examination; Absence of any condition that could affect the participant's safety or wellbeing or their ability to understand and follow study procedures and requirements. * Maxillary Arch: Completely edentulous maxillary arch restored with a conventional full acrylic based upper complete denture. * Mandibular Arch: Dentate, partial or full edentulous mandibular arch. Partial or full edentulous arch may be restored with a stable complete, partial or implant supported denture. (Mandibular dentures are not used for assessments or measures). * Maxillary dentures must be considered to be moderately well-fitting at the screening visit. (Kapur Index, Olshan Modification: retention score \>2, stability score \>2). * Maxillary dentures must be considered to be well-made based on design and construction criteria specified in the protocol.
Exclusion criteria
* Women who are breast-feeding, are known to be pregnant or who are intending to become pregnant over the duration of the study. * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * Previous participation in this study or in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit. * Recent history (within the last year) of alcohol or other substance abuse. * Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participant or undermines the data validity. * Implanted with a cardiac pacemaker. * Daily doses of medication (example Antibiotics, Inhaled steroids etc.) that might interfere with ability to perform the study according to protocol or might affect the efficacy assessments (as determined by the Investigator/ Examiner). * Any clinically significant or relevant oral abnormality that, in the opinion of the Investigator, could affect the participant's participation in the study. * Any pre-existing oral irritations. * Any recent (within 30 days) gingival /oral surgery. * Participants who are unwilling to refrain from smoking, including e-cigarettes and the use of chewing tobacco or other tobacco products for the duration of the study. * An employee of the sponsor or the study site or members of their immediate family. * An employee of any toothpaste manufacturer or their immediate family.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Aerobic Bacteria Microbial Count on Day 7 | Baseline (Day 0 pre-treatment), Day 7 (post-treatment) | 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. |
| Change From Baseline in Anaerobic Bacteria Microbial Count on Day 7 | 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 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. |
| Change From Baseline in Candidal Microbial Count on Day 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Aerobic Bacteria Microbial Count on Day 3 | 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. |
| Change From Baseline in Anaerobic Bacteria Microbial Count on Day 3 | 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 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 3. |
| Change From Baseline in Candidal Microbial Count on Day 3 | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
All participants were recruited at a single center in United Kingdom.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants were included for baseline evaluation. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Continuous | 68.7 years STANDARD_DEVIATION 5.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 19 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 8 / 19 | 8 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Change From Baseline in Aerobic Bacteria Microbial Count on Day 7
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denture Cleanser Tablet: Daily Use Period | Change From Baseline in Aerobic Bacteria Microbial Count on Day 7 | -1.78 log10(CFU[colony forming unit]/disc+1) | Standard Deviation 2.248 |
| Denture Cleanser Tablet: Weekly Use | Change From Baseline in Aerobic Bacteria Microbial Count on Day 7 | -1.20 log10(CFU[colony forming unit]/disc+1) | Standard Deviation 2.636 |
Comparison: H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.p-value: 0.014495% CI: [-1.53, -0.196]ANCOVA
Primary
Change From Baseline in Anaerobic Bacteria Microbial Count on Day 7
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denture Cleanser Tablet: Daily Use Period | Change From Baseline in Anaerobic Bacteria Microbial Count on Day 7 | -1.57 log10(CFU/disc+1) | Standard Deviation 2.478 |
| Denture Cleanser Tablet: Weekly Use | Change From Baseline in Anaerobic Bacteria Microbial Count on Day 7 | -1.54 log10(CFU/disc+1) | Standard Deviation 2.586 |
Comparison: H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.p-value: 0.187995% CI: [-1.23, 0.261]ANCOVA
Primary
Change From Baseline in Candidal Microbial Count on Day 7
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denture Cleanser Tablet: Daily Use Period | Change From Baseline in Candidal Microbial Count on Day 7 | 0.0 log10(CFU/disc+1) | Standard Deviation 0 |
| Denture Cleanser Tablet: Weekly Use | Change From Baseline in Candidal Microbial Count on Day 7 | 0.0 log10(CFU/disc+1) | Standard Deviation 0 |
Secondary
Change From Baseline in Aerobic Bacteria Microbial Count on Day 3
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.
Time frame: Baseline (Day 0 pre-treatment), Day 3 (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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denture Cleanser Tablet: Daily Use Period | Change From Baseline in Aerobic Bacteria Microbial Count on Day 3 | -1.74 log10(CFU/disc+1) | Standard Deviation 1.917 |
| Denture Cleanser Tablet: Weekly Use | Change From Baseline in Aerobic Bacteria Microbial Count on Day 3 | 0.36 log10(CFU/disc+1) | Standard Deviation 3.019 |
Secondary
Change From Baseline in Anaerobic Bacteria Microbial Count on Day 3
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 3.
Time frame: Baseline (Day 0 pre-treatment), Day 3 (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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denture Cleanser Tablet: Daily Use Period | Change From Baseline in Anaerobic Bacteria Microbial Count on Day 3 | -1.74 log10(CFU/disc+1) | Standard Deviation 2.134 |
| Denture Cleanser Tablet: Weekly Use | Change From Baseline in Anaerobic Bacteria Microbial Count on Day 3 | 1.08 log10(CFU/disc+1) | Standard Deviation 2.753 |
Secondary
Change From Baseline in Candidal Microbial Count on Day 3
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.
Time frame: Baseline (Day 0 pre-treatment), Day 3 (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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Denture Cleanser Tablet: Daily Use Period | Change From Baseline in Candidal Microbial Count on Day 3 | 0.0 log10(CFU/disc+1) | Standard Deviation 0 |
| Denture Cleanser Tablet: Weekly Use | Change From Baseline in Candidal Microbial Count on Day 3 | 0.0 log10(CFU/disc+1) | Standard Deviation 0 |