Dental Plaque
Conditions
Brief summary
The aim of this exploratory study is to assess the ability of two test toothpastes containing 0.6% w/w zinc chloride stabilised with sodium citrate in a sodium lauryl sulfate (SLS)-containing base to reduce glycolytic metabolism and viability of de novo plaque bacteria using the plaque glycolysis regrowth model (PGRM).
Interventions
OTHERTest zinc-IPMP toothpaste
Test toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm fluoride as sodium fluoride.
OTHERTest zinc non- IPMP toothpaste
Test toothpaste containing 0.6% w/w zinc chloride, 0% w/w IPMP and 1426ppm fluoride as sodium fluoride.
OTHERPositive control
Positive control toothpaste containing 0.454% w/w stannous fluoride (Fluoride Toothpaste (1100ppm Fluoride as stannous fluoride)).
OTHERSLS negative control
Negative control toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride
OTHERnon-SLS negative control
Negative control toothpaste containing 1426 ppm fluoride as sodium fluoride
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. * 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. * Plaque sample acidogenicity in the pH range 5.0 to 5.7 at Visit.
Exclusion criteria
* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. * Women who are breast-feeding. * Currently taking antibiotics or have taken antibiotics within 2 weeks of plaque assessment (Visit 2). A participant with any medical history that may prevent them from participating in the study until study conclusion (such as diabetes). * Any sign of grossly carious lesions (active), moderate or severe periodontal conditions, or severe tooth wear. * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * Current smokers, or smokers who have quit within 6 months of screening, or participants currently using smokeless forms of tobacco, e.g. Gutkha, Pan containing tobacco, Pan Masala. * Current active caries or periodontitis that may compromise, in the opinion of the investigator, study outcomes or the health of the subject. * Restorations in a poor state of repair that may, in the opinion of the investigator, compromise study outcomes or the health of the participant. * Partial dentures or orthodontic appliances that may, in the opinion of the investigator, compromise study outcomes or the health of the participant. * Recent history (within the last year) of alcohol or other substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control | Baseline up to 90 minutes (min) | AUCgly(0-90) of Test zinc-IPMP and non-SLS negative control was calculated using trapezoidal method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | Baseline up to 90 min | AUCgly(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method. |
| AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | Baseline up to 90 min | AUCregrowth(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method. |
| AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | Baseline up to 90 min | AUClive:dead(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method. |
Countries
United Kingdom
Participant flow
Pre-assignment details
A total of 150 participants were screened, of which 45 participants were randomized and 44 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants were included for baseline evaluation. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal of consent | 1 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Continuous | 39.4 Years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 44 | 6 / 44 | 6 / 45 | 3 / 44 | 2 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 | 0 / 45 | 0 / 44 | 0 / 44 |
Outcome results
Primary
Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control
AUCgly(0-90) of Test zinc-IPMP and non-SLS negative control was calculated using trapezoidal method.
Time frame: Baseline up to 90 minutes (min)
Population: The Per Protocol (PP) population defined as those participants in the intent to treat (ITT) population who had at least one assessment of efficacy considered unaffected by protocol violation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Zinc-IPMP | Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control | 42.64 plaque incubation pH*min | Standard Error 3.437 |
| Non-SLS Negative Control | Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control | 2.46 plaque incubation pH*min | Standard Error 3.303 |
p-value: <0.000195% CI: [32.37, 47.99]ANCOVA
Secondary
AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control
AUCgly(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.
Time frame: Baseline up to 90 min
Population: PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Zinc-IPMP | AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | 42.64 plaque incubation pH*min | Standard Error 3.437 |
| Non-SLS Negative Control | AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | 34.20 plaque incubation pH*min | Standard Error 3.354 |
| Positive Control | AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | 28.88 plaque incubation pH*min | Standard Error 3.384 |
| Non-SLS Negative Control | AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | 2.46 plaque incubation pH*min | Standard Error 3.303 |
| SLS Negative Control | AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | 31.78 plaque incubation pH*min | Standard Error 3.512 |
p-value: <0.000195% CI: [18.94, 33.88]ANCOVA
p-value: 0.482395% CI: [-11.18, 5.37]ANCOVA
p-value: 0.007295% CI: [3.13, 18.59]ANCOVA
p-value: 0.000995% CI: [6.01, 21.53]ANCOVA
p-value: 0.028695% CI: [0.93, 15.95]ANCOVA
p-value: 0.157395% CI: [-2.15, 12.79]ANCOVA
p-value: <0.000195% CI: [-37.2, -21.43]ANCOVA
p-value: <0.000195% CI: [24.18, 39.3]ANCOVA
p-value: 0.517495% CI: [-5.08, 9.92]ANCOVA
Secondary
AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control
AUClive:dead(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.
Time frame: Baseline up to 90 min
Population: PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Zinc-IPMP | AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | 75.23 live:dead stain ratio*min | Standard Error 568.834 |
| Non-SLS Negative Control | AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | -691.41 live:dead stain ratio*min | Standard Error 508.108 |
| Positive Control | AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | 72.19 live:dead stain ratio*min | Standard Error 491.718 |
| Non-SLS Negative Control | AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | 346.11 live:dead stain ratio*min | Standard Error 431.974 |
| SLS Negative Control | AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | -601.87 live:dead stain ratio*min | Standard Error 499.74 |
p-value: 0.666495% CI: [-1550.45, 1002.61]ANCOVA
p-value: 0.324995% CI: [-692.21, 2040.33]ANCOVA
p-value: 0.354495% CI: [-784.16, 2138.35]ANCOVA
p-value: 0.996795% CI: [-1469.45, 1475.52]ANCOVA
p-value: 0.297695% CI: [-703.26, 2236.54]ANCOVA
p-value: 0.270295% CI: [-2144.45, 617.25]ANCOVA
p-value: 0.151195% CI: [-361.95, 2257.9]ANCOVA
p-value: 0.699895% CI: [-1680.58, 1138.82]ANCOVA
p-value: 0.12195% CI: [-2361.33, 286.29]ANCOVA
p-value: 0.893595% CI: [-1439.5, 1260.41]ANCOVA
Secondary
AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control
AUCregrowth(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.
Time frame: Baseline up to 90 min
Population: PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Test Zinc-IPMP | AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | -239.81 regrowth ratio*min | Standard Error 40.122 |
| Non-SLS Negative Control | AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | -240.86 regrowth ratio*min | Standard Error 39.118 |
| Positive Control | AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | -179.55 regrowth ratio*min | Standard Error 39.415 |
| Non-SLS Negative Control | AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | 53.66 regrowth ratio*min | Standard Error 38.443 |
| SLS Negative Control | AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | -215.08 regrowth ratio*min | Standard Error 40.35 |
p-value: <0.000195% CI: [-332.88, -133.55]ANCOVA
p-value: 0.501895% CI: [-69.9, 140.96]ANCOVA
p-value: 0.632595% CI: [-128.07, 78.61]ANCOVA
p-value: 0.242795% CI: [-162.72, 42.21]ANCOVA
p-value: 0.983495% CI: [-100.5, 102.61]ANCOVA
p-value: 0.222695% CI: [-161.14, 38.52]ANCOVA
p-value: <0.000195% CI: [165.98, 371.51]ANCOVA
p-value: <0.000195% CI: [-396.03, -190.91]ANCOVA
p-value: <0.000195% CI: [-395.43, -193.62]ANCOVA
p-value: 0.608695% CI: [-126.53, 74.96]ANCOVA