Trial · NCT03587428
Effect of Two Toothpastes on Bacteria in Saliva
NCT03587428, Not applicable, Completed, GlaxoSmithKline; results first posted 2019-07-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Two Toothpastes on Bacteria in Saliva. Trials, record NCT03587428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03587428
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Two Toothpastes on Bacteria in Saliva
- NCT number
- NCT03587428
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 15 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Oral Health
- Interventions
- Zinc-A toothpaste, Zinc-B toothpaste, Mineral water
- First posted
- 2018-07-16
- Last updated
- 2019-07-15
- Results first posted
- 2019-07-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Change from baseline in log10-transformed AUC 0-2hr | 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. |
| Secondary | Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique | Baseline up to 2 hours | 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. |
| Secondary | Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique | At Baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour and 2 hours post-treatment | 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. |
| Secondary | Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique | At Baseline, 30 minutes, 1 hour and 2 hours post-treatment | Anaerobic bacteria were counted using live:dead staining technique. Change from baseline was calculated for the ratio of live to dead bacteria. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Change from baseline in log10-transformed AUC 0-2hr | The efficacy analysis was performed on Intent to Treat (ITT) population. | Log10 (cells/ml) | MEAN |
| SECONDARY | Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique | Baseline up to 2 hours | The efficacy analysis was performed on ITT population. | Ratio (unitless) | MEAN |
| SECONDARY | Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique | At Baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour and 2 hours post-treatment | The efficacy analysis was performed on ITT population. | Log10 (cells/ml) | MEAN |
| SECONDARY | Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique | At Baseline, 30 minutes, 1 hour and 2 hours post-treatment | The efficacy analysis was performed on ITT population. | Ratio (unitless) | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Zinc-A Toothpaste | At Baseline | 8.818 | Standard Deviation 1.3909 | Log10 (cells/ml) |
| 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 | Zinc-B Toothpaste | At Baseline | 8.785 | Standard Deviation 1.3643 | Log10 (cells/ml) |
| 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 | Mineral Water | At Baseline | 8.845 | Standard Deviation 0.7271 | Log10 (cells/ml) |
| 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 | Zinc-A Toothpaste | Change from Baseline in AUC at 120 minutes | -0.037 | Standard Deviation 2.4945 | Log10 (cells/ml) |
| 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 | Zinc-B Toothpaste | Change from Baseline in AUC at 120 minutes | -0.348 | Standard Deviation 2.8109 | Log10 (cells/ml) |
| 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 | Mineral Water | Change from Baseline in AUC at 120 minutes | 0.193 | Standard Deviation 1.6106 | Log10 (cells/ml) |
| Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique | Zinc-A Toothpaste | At Baseline | 0.758 | Standard Deviation 0.3961 | Ratio (unitless) |
| Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique | Zinc-B Toothpaste | At Baseline | 0.946 | Standard Deviation 0.1495 | Ratio (unitless) |
| Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique | Mineral Water | At Baseline | 0.906 | Standard Deviation 0.1856 | Ratio (unitless) |
| Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique | Zinc-A Toothpaste | Change from Baseline in AUC at 120 minutes | -7.612 | Standard Deviation 5.5419 | Ratio (unitless) |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | B-C-A | 3 | |
| Period 1 | STARTED | C-B-A | 2 | |
| Period 1 | STARTED | A-B-C | 3 | |
| Period 1 | STARTED | C-A-B | 3 | |
| Period 1 | STARTED | B-A-C | 2 | |
| Period 1 | STARTED | A-C-B | 2 | |
| Period 1 | COMPLETED | B-C-A | 3 | |
| Period 1 | COMPLETED | C-B-A | 2 | |
| Period 1 | COMPLETED | A-B-C | 3 | |
| Period 1 | COMPLETED | C-A-B | 3 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zinc-A Toothpaste | 0 | 15 |
| Total, all-cause mortality | Zinc-B Toothpaste | 0 | 15 |
| Total, all-cause mortality | Mineral Water | 0 | 15 |
| Total, other adverse events | Zinc-A Toothpaste | 0 | 15 |
| Total, other adverse events | Zinc-B Toothpaste | 0 | 15 |
| Total, other adverse events | Mineral Water | 0 | 15 |
| Total, serious adverse events | Zinc-A Toothpaste | 0 | 15 |
| Total, serious adverse events | Zinc-B Toothpaste | 0 | 15 |
| Total, serious adverse events | Mineral Water | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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