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This study investigated the ability of two zinc-containing toothpaste formulations (Zinc A and Zinc B) to reduce the level of bacteria in saliva in the two-hour period after their use, compared to the effect of rinsing with water alone.
This was a single centre, three treatment, randomized, blinded, cross-over study which involved rinsing with slurries of two sodium fluoride-silica dentifrices containing zinc chloride and sodium citrate, and with water alone. The study consisted of four Visits: Visit 1 (Screening), Visit 2 (Treatment 1), Visit 3 (Treatment 2), Visit 4 (Treatment 3). There was a minimum two days wash out period before the first treatment visit and between treatment visits to avoid any treatment carry-over effect. During that time participants brushed as normal (twice-daily) at home with a washout toothpaste and a toothbrush which was provided at screening. Participants were required not to brush their teeth on the morning of the treatment visits and not to eat or drink for 2 hours prior to the treatment visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinc-A toothpaste | Experimental | In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry. |
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| Zinc-B toothpaste | Experimental | In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry. |
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| Mineral Water | Other | In this arm, participants received mineral water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc-A toothpaste | Drug | Participants received 6.0 grams (g) [± 0.3g] of the Zinc-A toothpaste in the form of slurry, one day per treatment (with at least 2 [generally 7] days between treatments. Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Area Under the Curve Between 0 and 2 Hours (AUC [0-2] Hours) for Total Viable Counts (TVCs) of Bacteria in Saliva Using Traditional Plating Technique | Area Under the Curve (AUC) between 0 and 2 hours (hr) was assessed using traditional plating technique which provides the total viable counts (TVCs) of anaerobic bacteria. This outcome measure is AUC of change from baseline in log TVC. AUC for each time-point were calculated individually for each participant for each treatment and were aggregated into an AUC measurement. The aggregated AUC measurement was calculated in the order that first the collected data is logged which is further analyzed by change in log. Then, AUC 0-2hr change in log was calculated using the trapezoidal rule. The resulted values were then divided by 2hr to take out time units and are logged to calculate bacteria count. Hence, the outcome measure calculates change from baseline in log10-transformed AUC 0-2hr over the range from pre-treatment time point (0hr) to the concentration at 120 minutes (min) i.e., 2hr. | Change from baseline in log10-transformed AUC 0-2hr |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique | Anaerobic bacteria were counted using live:dead staining technique. Change from baseline in AUC (0-2)hr was calculated for the ratio of live and dead bacteria. Viable bacterial counts for each time-point were calculated individually for each participant for each treatment and were aggregated into an AUC measurement. AUC was calculated using the trapezoidal rule and using nominal time points. The resulted values were then divided by 2hr to take out time units. The AUC was calculated over the range from pre-treatment time point (0hr) to 2hr. In this outcome measure, the change from baseline is calculated in log ratio of live: dead. |
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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 | Weybridge | KT13 0DE | United Kingdom |
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A total of 16 participants were screened, out of which 1 did not met the study criteria. Total of 15 participants were randomized to study treatments.
All the participants were recruited from one center in United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | B-C-A | In this arm, participants received toothpaste in the form of slurry. The flow of events were first product B, then product C followed by product A, where, A is Zinc-A toothpaste, B is Zinc-B toothpaste and C is water. |
| FG001 | C-B-A | In this arm, participants received toothpaste in the form of slurry. The flow of events were first product C, then product B followed by product A, where, A is Zinc-A toothpaste, B is Zinc-B toothpaste and C is water. |
| FG002 | A-B-C | In this arm, participants received toothpaste in the form of slurry. The flow of events were first product A, then product B followed by product C, where, A is Zinc-A toothpaste, B is Zinc-B toothpaste and C is water. |
| FG003 | C-A-B | In this arm, participants received toothpaste in the form of slurry. The flow of events were first product C, then product A followed by product B, where, A is Zinc-A toothpaste, B is Zinc-B toothpaste and C is water. |
| FG004 | B-A-C | In this arm, participants received toothpaste in the form of slurry. The flow of events were first product B, then product A followed by product C, where, A is Zinc-A toothpaste, B is Zinc-B toothpaste and C is water. |
| FG005 | A-C-B | In this arm, participants received toothpaste in the form of slurry. The flow of events were first product A, then product C followed by product B, where, A is Zinc-A toothpaste, B is Zinc-B toothpaste and C is water. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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All participants completed the study and were included in the safety and intent-to-treat (ITT) populations. All efficacy analyses were conducted on the ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Includes participants that were given interventions: Zinc-A toothpaste or Zinc-B toothpaste or Mineral Water |
| 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 | Change From Baseline in Area Under the Curve Between 0 and 2 Hours (AUC [0-2] Hours) for Total Viable Counts (TVCs) of Bacteria in Saliva Using Traditional Plating Technique | Area Under the Curve (AUC) between 0 and 2 hours (hr) was assessed using traditional plating technique which provides the total viable counts (TVCs) of anaerobic bacteria. This outcome measure is AUC of change from baseline in log TVC. AUC for each time-point were calculated individually for each participant for each treatment and were aggregated into an AUC measurement. The aggregated AUC measurement was calculated in the order that first the collected data is logged which is further analyzed by change in log. Then, AUC 0-2hr change in log was calculated using the trapezoidal rule. The resulted values were then divided by 2hr to take out time units and are logged to calculate bacteria count. Hence, the outcome measure calculates change from baseline in log10-transformed AUC 0-2hr over the range from pre-treatment time point (0hr) to the concentration at 120 minutes (min) i.e., 2hr. | The efficacy analysis was performed on Intent to Treat (ITT) population. | Posted | Mean | Standard Deviation | Log10 (cells/ml) | Change from baseline in log10-transformed AUC 0-2hr |
approximately 28 days
All subjects who received treatment were included in the safety population. Adverse Events (AEs) were summarized by treatment group.
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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 | Zinc-A Toothpaste | In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| ID | Term |
|---|---|
| D008900 | Mineral Waters |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 |
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| Zinc-B toothpaste | Drug | Participants received 6.0 grams (g) [± 0.3g] of the Zinc-B toothpaste in the form of slurry, one day per treatment (with at least 2 [generally 7] days between treatments. Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink. |
|
| Mineral water | Other | Participants received 6.0g (±0.3g) of mineral water (by weighing out), one day per treatment (with at least 2 [generally 7] days between treatments). Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink. |
|
| Baseline up to 2 hours |
| Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique | Anaerobic bacteria were counted using traditional plating technique. Total viable bacterial counts for each time-point was calculated individually for each participant for each treatment. Change from baseline in log 10 transformed total viable bacterial values was calculated. | At Baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour and 2 hours post-treatment |
| Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique | Anaerobic bacteria were counted using live:dead staining technique. Change from baseline was calculated for the ratio of live to dead bacteria. | At Baseline, 30 minutes, 1 hour and 2 hours post-treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | Zinc-A Toothpaste | In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry. |
| OG001 | Zinc-B Toothpaste | In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry. |
| OG002 | Mineral Water | In this arm, participants received mineral water. |
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| Secondary | Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique | Anaerobic bacteria were counted using live:dead staining technique. Change from baseline in AUC (0-2)hr was calculated for the ratio of live and dead bacteria. Viable bacterial counts for each time-point were calculated individually for each participant for each treatment and were aggregated into an AUC measurement. AUC was calculated using the trapezoidal rule and using nominal time points. The resulted values were then divided by 2hr to take out time units. The AUC was calculated over the range from pre-treatment time point (0hr) to 2hr. In this outcome measure, the change from baseline is calculated in log ratio of live: dead. | The efficacy analysis was performed on ITT population. | Posted | Mean | Standard Deviation | Ratio (unitless) | Baseline up to 2 hours |
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| Secondary | Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique | Anaerobic bacteria were counted using traditional plating technique. Total viable bacterial counts for each time-point was calculated individually for each participant for each treatment. Change from baseline in log 10 transformed total viable bacterial values was calculated. | The efficacy analysis was performed on ITT population. | Posted | Mean | Standard Deviation | Log10 (cells/ml) | At Baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour and 2 hours post-treatment |
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| Secondary | Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique | Anaerobic bacteria were counted using live:dead staining technique. Change from baseline was calculated for the ratio of live to dead bacteria. | The efficacy analysis was performed on ITT population. | Posted | Mean | Standard Deviation | Ratio (unitless) | At Baseline, 30 minutes, 1 hour and 2 hours post-treatment |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Zinc-B Toothpaste | In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Mineral Water | In this arm, participants received mineral water. | 0 | 15 | 0 | 15 | 0 | 15 |
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.
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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| At 30 minutes |
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| At 1 hour |
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| At 2 hour |
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| At 2 hour |
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