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Effect of Two Toothpastes on Bacteria in Saliva

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ClinicalTrials.gov Identifier: NCT03587428
Recruitment Status : Completed
First Posted : July 16, 2018
Results First Posted : July 15, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Oral Health
Interventions Drug: Zinc-A toothpaste
Drug: Zinc-B toothpaste
Other: Mineral water
Enrollment 15
Recruitment Details All the participants were recruited from one center in United Kingdom.
Pre-assignment Details 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.
Arm/Group Title B-C-A C-B-A A-B-C C-A-B B-A-C A-C-B
Hide Arm/Group Description 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. 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. 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. 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. 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. 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 Title: Period 1
Started 3 2 3 3 2 2
Completed 3 2 3 3 2 2
Not Completed 0 0 0 0 0 0
Period Title: Period 2
Started 3 2 3 3 2 2
Completed 3 2 3 3 2 2
Not Completed 0 0 0 0 0 0
Period Title: Period 3
Started 3 2 3 3 2 2
Completed 3 2 3 3 2 2
Not Completed 0 0 0 0 0 0
Arm/Group Title Overall
Hide Arm/Group Description Includes participants that were given interventions: Zinc-A toothpaste or Zinc-B toothpaste or Mineral Water
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
37.1  (10.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Change from baseline in log10-transformed AUC 0-2hr
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis was performed on Intent to Treat (ITT) population.
Arm/Group Title Zinc-A Toothpaste Zinc-B Toothpaste Mineral Water
Hide Arm/Group Description:
In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.
In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.
In this arm, participants received mineral water.
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: Log10 (cells/ml)
At Baseline 8.818  (1.3909) 8.785  (1.3643) 8.845  (0.7271)
Change from Baseline in AUC at 120 minutes -0.037  (2.4945) -0.348  (2.8109) 0.193  (1.6106)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zinc-A Toothpaste, Mineral Water
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1787
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3252
Confidence Interval (2-Sided) 95%
-0.8101 to 0.1596
Estimation Comments Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zinc-B Toothpaste, Mineral Water
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7037
Confidence Interval (2-Sided) 95%
-1.1886 to -0.2187
Estimation Comments Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.
2.Secondary Outcome
Title Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique
Hide Description 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.
Time Frame Baseline up to 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis was performed on ITT population.
Arm/Group Title Zinc-A Toothpaste Zinc-B Toothpaste Mineral Water
Hide Arm/Group Description:
In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.
In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.
In this arm, participants received mineral water.
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: Ratio (unitless)
At Baseline 0.758  (0.3961) 0.946  (0.1495) 0.906  (0.1856)
Change from Baseline in AUC at 120 minutes -7.612  (5.5419) -10.927  (4.6267) -1.024  (3.7681)
3.Secondary Outcome
Title Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique
Hide Description 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.
Time Frame At Baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour and 2 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis was performed on ITT population.
Arm/Group Title Zinc-A Toothpaste Zinc-B Toothpaste Mineral Water
Hide Arm/Group Description:
In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.
In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.
In this arm, participants received mineral water.
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: Log10 (cells/ml)
At 5 minutes -0.364  (1.3410) -0.474  (1.4832) 0.144  (0.5679)
At 15 minutes -0.030  (1.2444) -0.214  (1.5142) 0.161  (0.9736)
At 30 minutes 0.092  (1.4285) -0.130  (1.5997) -0.177  (1.0780)
At 1 hour -0.032  (1.2486) -0.175  (1.4857) 0.193  (0.7781)
At 2 hour 0.009  (1.4097) -0.129  (1.5035) 0.127  (0.8379)
4.Secondary Outcome
Title Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique
Hide Description Anaerobic bacteria were counted using live:dead staining technique. Change from baseline was calculated for the ratio of live to dead bacteria.
Time Frame At Baseline, 30 minutes, 1 hour and 2 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis was performed on ITT population.
Arm/Group Title Zinc-A Toothpaste Zinc-B Toothpaste Mineral Water
Hide Arm/Group Description:
In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.
In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.
In this arm, participants received mineral water.
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: Ratio (unitless)
At 30 minutes -4.701  (3.3349) -6.728  (2.7295) -0.049  (1.8977)
At 1 hour -4.259  (3.1983) -6.153  (2.6444) -0.820  (2.4004)
At 2 hour -3.236  (3.1452) -5.419  (2.6849) -0.769  (2.7484)
Time Frame approximately 28 days
Adverse Event Reporting Description All subjects who received treatment were included in the safety population. Adverse Events (AEs) were summarized by treatment group.
 
Arm/Group Title Zinc-A Toothpaste Zinc-B Toothpaste Mineral Water
Hide Arm/Group Description In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry. In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry. In this arm, participants received mineral water.
All-Cause Mortality
Zinc-A Toothpaste Zinc-B Toothpaste Mineral Water
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Zinc-A Toothpaste Zinc-B Toothpaste Mineral Water
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Zinc-A Toothpaste Zinc-B Toothpaste Mineral Water
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03587428     History of Changes
Other Study ID Numbers: 202287
First Submitted: July 3, 2018
First Posted: July 16, 2018
Results First Submitted: October 15, 2018
Results First Posted: July 15, 2019
Last Update Posted: July 15, 2019