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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test zinc-IPMP toothpaste | Experimental | Rinse with preprepared slurry of toothpaste in 10 milliliter (mL) water for 60 seconds(s) followed by rinse with 10mL water |
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| Test zinc non- IPMP toothpaste | Experimental | Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water |
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| Positive control Toothpaste | Active Comparator | Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water |
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| SLS Negative Control | Active Comparator | Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water |
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| non-SLS negative control | Active Comparator | Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test zinc-IPMP toothpaste | Other | Test toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm fluoride as sodium fluoride. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 90 minutes (min) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 90 min |
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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 | Manchester | M16 9HQ | United Kingdom |
A total of 150 participants were screened, of which 45 participants were randomized and 44 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | This was a single-centre, analyst and examiner (plaque sample collector)-blind, randomized, five-treatment, five-period, cross-over study in healthy adult participants. Each participant received each of the five interventions i.e., Test Zinc-isopropylmethylphenol (IPMP), Test Zinc non-IPMP, Positive control, non-sodium lauryl sulphate (SLS) negative control, SLS negative control. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants were included for baseline evaluation. |
| 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 | 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. | 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. | Posted | Least Squares Mean | Standard Error | plaque incubation pH*min | Baseline up to 90 minutes (min) |
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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 | Test Zinc-IPMP Toothpaste | Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LIP ULCERATION | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Test zinc non- IPMP toothpaste | Other | Test toothpaste containing 0.6% w/w zinc chloride, 0% w/w IPMP and 1426ppm fluoride as sodium fluoride. |
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| Positive control | Other | Positive control toothpaste containing 0.454% w/w stannous fluoride (Fluoride Toothpaste (1100ppm Fluoride as stannous fluoride)). |
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| SLS negative control | Other | Negative control toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride |
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| non-SLS negative control | Other | Negative control toothpaste containing 1426 ppm fluoride as sodium fluoride |
|
| 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. |
| 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 | 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. | Baseline up to 90 min |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Non-SLS Negative Control |
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water |
|
|
|
| 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. | PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation. | Posted | Least Squares Mean | Standard Error | plaque incubation pH*min | Baseline up to 90 min |
|
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|
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| 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. | PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation. | Posted | Least Squares Mean | Standard Error | regrowth ratio*min | Baseline up to 90 min |
|
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| 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. | PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation. | Posted | Least Squares Mean | Standard Error | live:dead stain ratio*min | Baseline up to 90 min |
|
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|
| 0 |
| 44 |
| 8 |
| 44 |
| EG001 | Test Zinc Non- IPMP Toothpaste | Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water | 0 | 44 | 6 | 44 |
| EG002 | Positive Control Toothpaste | Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water | 0 | 45 | 6 | 45 |
| EG003 | Non-SLS Negative Control | Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water | 0 | 44 | 3 | 44 |
| EG004 | SLS Negative Control | Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water | 0 | 44 | 2 | 44 |
| MOUTH ULCERATION | Gastrointestinal disorders |
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| NAUSEA | Gastrointestinal disorders |
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| PARAESTHESIA ORAL | Gastrointestinal disorders |
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| TOOTHACHE | Gastrointestinal disorders |
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| COATING IN MOUTH | Gastrointestinal disorders |
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| GINGIVAL ULCERATION | Gastrointestinal disorders |
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| RHINITIS | Infections and infestations |
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| ORAL HERPES | Infections and infestations |
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| PERICORONITIS | Infections and infestations |
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| TRAUMATIC ULCER | Injury, poisoning and procedural complications |
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| LACERATION | Injury, poisoning and procedural complications |
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| LIGAMENT SPRAIN | Injury, poisoning and procedural complications |
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| SUPERFICIAL INJURY OF EYE | Injury, poisoning and procedural complications |
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| TOOTH FRACTURE | Injury, poisoning and procedural complications |
|
| HEADACHE | Nervous system disorders |
|
| DEVICE FAILURE | General disorders |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders |
|
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.
| ANCOVA | 0.4823 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | -2.91 | 2-Sided | 95 | -11.18 | 5.37 | Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of glycolysis for the first named treatment. | Superiority or Other |
| ANCOVA | 0.0072 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 10.86 | 2-Sided | 95 | 3.13 | 18.59 | Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment. | Superiority or Other |
| ANCOVA | 0.0009 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 13.77 | 2-Sided | 95 | 6.01 | 21.53 | Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment. | Superiority or Other |
| ANCOVA | 0.0286 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 8.44 | 2-Sided | 95 | 0.93 | 15.95 | Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment. | Superiority or Other |
| ANCOVA | 0.1573 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 5.32 | 2-Sided | 95 | -2.15 | 12.79 | Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment. | Superiority or Other |
| ANCOVA | <0.0001 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | -29.32 | 2-Sided | 95 | -37.20 | -21.43 | Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment. | Superiority or Other |
| ANCOVA | <0.0001 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 31.74 | 2-Sided | 95.0 | 24.18 | 39.30 | Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment. | Superiority or Other |
| ANCOVA | 0.5174 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 2.42 | 2-Sided | 95 | -5.08 | 9.92 | Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment. | Superiority or Other |
| ANCOVA | 0.5018 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 35.53 | 2-Sided | 95 | -69.90 | 140.96 | Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment. | Superiority or Other |
| ANCOVA | 0.6325 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | -24.73 | 2-Sided | 95 | -128.07 | 78.61 | Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment. | Superiority or Other |
| ANCOVA | 0.2427 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | -60.26 | 2-Sided | 95 | -162.72 | 42.21 | Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment. | Superiority or Other |
| ANCOVA | 0.9834 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 1.05 | 2-Sided | 95 | -100.50 | 102.61 | Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment. | Superiority or Other |
| ANCOVA | 0.2226 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | -61.31 | 2-Sided | 95 | -161.14 | 38.52 | Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment. | Superiority or Other |
| ANCOVA | <0.0001 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 268.74 | 2-Sided | 95 | 165.98 | 371.51 | Difference is second named treatment(non-SLS negative control) minus first named treatment (SLS negative control) such that a negative difference indicates a greater inhibition of plaque | Superiority or Other |
| ANCOVA | <0.0001 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | -293.47 | 2-Sided | 95 | -396.03 | -190.91 | Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment. | Superiority or Other |
| ANCOVA | <0.0001 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | -294.53 | 2-Sided | 95 | -395.43 | -193.62 | Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment. | Superiority or Other |
| ANCOVA | 0.6086 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | -25.78 | 2-Sided | 95 | -126.53 | 74.96 | Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment. | Superiority or Other |
| ANCOVA | 0.3249 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 674.06 | 2-Sided | 95 | -692.21 | 2040.33 | Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment. | Superiority or Other |
| ANCOVA | 0.3544 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 677.09 | 2-Sided | 95 | -784.16 | 2138.35 | Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment. | Superiority or Other |
| ANCOVA | 0.9967 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 3.04 | 2-Sided | 95 | -1469.45 | 1475.52 | Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment. | Superiority or Other |
| ANCOVA | 0.2976 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 766.64 | 2-Sided | 95 | -703.26 | 2236.54 | Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment. | Superiority or Other |
| ANCOVA | 0.2702 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | -763.60 | 2-Sided | 95 | -2144.45 | 617.25 | Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment. | Superiority or Other |
| ANCOVA | 0.1511 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | 947.97 | 2-Sided | 95 | -361.95 | 2257.90 | Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment. | Superiority or Other |
| ANCOVA | 0.6998 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | -270.88 | 2-Sided | 95 | -1680.58 | 1138.82 | Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment. | Superiority or Other |
| ANCOVA | 0.1210 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant -level pre-treatment values and period minus participant -level pre-treatment values as covariates in the model. | LS mean difference | -1037.52 | 2-Sided | 95 | -2361.33 | 286.29 | Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment. | Superiority or Other |
| ANCOVA | 0.8935 | Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model. | LS mean difference | -89.54 | 2-Sided | 95 | -1439.50 | 1260.41 | Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment. | Superiority or Other |