Trial Outcomes & Findings for Effect of Two Toothpastes on Bacteria in Saliva (NCT NCT03587428)

NCT ID: NCT03587428

Last Updated: 2019-07-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: Change from baseline in log10-transformed AUC 0-2hr
• Results posted on: 2019-07-15

Participant Flow

All the participants were recruited from one center in United Kingdom.

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.

Participant milestones

Measure	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.	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.	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.	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.	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.	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.
Period 1 STARTED	3	2	3	3	2	2
Period 1 COMPLETED	3	2	3	3	2	2
Period 1 NOT COMPLETED	0	0	0	0	0	0
Period 2 STARTED	3	2	3	3	2	2
Period 2 COMPLETED	3	2	3	3	2	2
Period 2 NOT COMPLETED	0	0	0	0	0	0
Period 3 STARTED	3	2	3	3	2	2
Period 3 COMPLETED	3	2	3	3	2	2
Period 3 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Two Toothpastes on Bacteria in Saliva

Baseline characteristics by cohort

Measure	Overall n=15 Participants Includes participants that were given interventions: Zinc-A toothpaste or Zinc-B toothpaste or Mineral Water
Age, Continuous	37.1 Years STANDARD_DEVIATION 10.15 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline in log10-transformed AUC 0-2hr

Population: The efficacy analysis was performed on Intent to Treat (ITT) population.

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.

Outcome measures

Measure	Zinc-A Toothpaste n=15 Participants In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.	Zinc-B Toothpaste n=15 Participants In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.	Mineral Water n=15 Participants In this arm, participants received mineral water.
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 At Baseline	8.818 Log10 (cells/ml) Standard Deviation 1.3909	8.785 Log10 (cells/ml) Standard Deviation 1.3643	8.845 Log10 (cells/ml) Standard Deviation 0.7271
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 AUC at 120 minutes	-0.037 Log10 (cells/ml) Standard Deviation 2.4945	-0.348 Log10 (cells/ml) Standard Deviation 2.8109	0.193 Log10 (cells/ml) Standard Deviation 1.6106

SECONDARY outcome

Timeframe: Baseline up to 2 hours

Population: The efficacy analysis was performed on ITT population.

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.

Outcome measures

Measure	Zinc-A Toothpaste n=15 Participants In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.	Zinc-B Toothpaste n=15 Participants In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.	Mineral Water n=15 Participants In this arm, participants received mineral water.
Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique At Baseline	0.758 Ratio (unitless) Standard Deviation 0.3961	0.946 Ratio (unitless) Standard Deviation 0.1495	0.906 Ratio (unitless) Standard Deviation 0.1856
Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique Change from Baseline in AUC at 120 minutes	-7.612 Ratio (unitless) Standard Deviation 5.5419	-10.927 Ratio (unitless) Standard Deviation 4.6267	-1.024 Ratio (unitless) Standard Deviation 3.7681

SECONDARY outcome

Timeframe: At Baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour and 2 hours post-treatment

Population: The efficacy analysis was performed on ITT population.

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.

Outcome measures

Measure	Zinc-A Toothpaste n=15 Participants In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.	Zinc-B Toothpaste n=15 Participants In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.	Mineral Water n=15 Participants In this arm, participants received mineral water.
Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique At 5 minutes	-0.364 Log10 (cells/ml) Standard Deviation 1.3410	-0.474 Log10 (cells/ml) Standard Deviation 1.4832	0.144 Log10 (cells/ml) Standard Deviation 0.5679
Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique At 15 minutes	-0.030 Log10 (cells/ml) Standard Deviation 1.2444	-0.214 Log10 (cells/ml) Standard Deviation 1.5142	0.161 Log10 (cells/ml) Standard Deviation 0.9736
Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique At 30 minutes	0.092 Log10 (cells/ml) Standard Deviation 1.4285	-0.130 Log10 (cells/ml) Standard Deviation 1.5997	-0.177 Log10 (cells/ml) Standard Deviation 1.0780
Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique At 1 hour	-0.032 Log10 (cells/ml) Standard Deviation 1.2486	-0.175 Log10 (cells/ml) Standard Deviation 1.4857	0.193 Log10 (cells/ml) Standard Deviation 0.7781
Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique At 2 hour	0.009 Log10 (cells/ml) Standard Deviation 1.4097	-0.129 Log10 (cells/ml) Standard Deviation 1.5035	0.127 Log10 (cells/ml) Standard Deviation 0.8379

SECONDARY outcome

Timeframe: At Baseline, 30 minutes, 1 hour and 2 hours post-treatment

Population: The efficacy analysis was performed on ITT population.

Anaerobic bacteria were counted using live:dead staining technique. Change from baseline was calculated for the ratio of live to dead bacteria.

Outcome measures

Measure	Zinc-A Toothpaste n=15 Participants In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.	Zinc-B Toothpaste n=15 Participants In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.	Mineral Water n=15 Participants In this arm, participants received mineral water.
Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique At 30 minutes	-4.701 Ratio (unitless) Standard Deviation 3.3349	-6.728 Ratio (unitless) Standard Deviation 2.7295	-0.049 Ratio (unitless) Standard Deviation 1.8977
Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique At 1 hour	-4.259 Ratio (unitless) Standard Deviation 3.1983	-6.153 Ratio (unitless) Standard Deviation 2.6444	-0.820 Ratio (unitless) Standard Deviation 2.4004
Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique At 2 hour	-3.236 Ratio (unitless) Standard Deviation 3.1452	-5.419 Ratio (unitless) Standard Deviation 2.6849	-0.769 Ratio (unitless) Standard Deviation 2.7484

Adverse Events

Zinc-A Toothpaste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Zinc-B Toothpaste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mineral Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER