Trial Outcomes & Findings for A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes (NCT NCT02856880)
NCT ID: NCT02856880
Last Updated: 2017-08-30
Results Overview
AUCgly(0-90) of Test zinc-IPMP and non-SLS negative control was calculated using trapezoidal method.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Baseline up to 90 minutes (min)
Results posted on
2017-08-30
Participant Flow
A total of 150 participants were screened, of which 45 participants were randomized and 44 completed the study.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
Received Test Zinc-IPMP
|
44
|
|
Overall Study
Received Test Zinc Non-IPMP
|
44
|
|
Overall Study
Received Positive Control
|
45
|
|
Overall Study
Received Non-SLS Negative Control
|
44
|
|
Overall Study
Received SLS Negative Control
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Withdrawal of consent
|
1
|
Baseline Characteristics
A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=45 Participants
All randomized participants were included for baseline evaluation.
|
|---|---|
|
Age, Continuous
|
39.4 Years
STANDARD_DEVIATION 12.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 90 minutes (min)Population: 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.
AUCgly(0-90) of Test zinc-IPMP and non-SLS negative control was calculated using trapezoidal method.
Outcome measures
| Measure |
Test Zinc-IPMP
n=14 Participants
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
|
Non-SLS Negative Control
n=15 Participants
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
|
Positive Control
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100ppm F as stannous fluoride) in 10mL water for 60 sec followed by rinse with 10mL water
|
Non-SLS Negative Control
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
|
SLS Negative Control
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150ppm fluoride as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
|
|---|---|---|---|---|---|
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Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control
|
42.64 plaque incubation pH*min
Standard Error 3.437
|
2.46 plaque incubation pH*min
Standard Error 3.303
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 90 minPopulation: PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.
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.
Outcome measures
| Measure |
Test Zinc-IPMP
n=14 Participants
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
|
Non-SLS Negative Control
n=14 Participants
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
|
Positive Control
n=14 Participants
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100ppm F as stannous fluoride) in 10mL water for 60 sec followed by rinse with 10mL water
|
Non-SLS Negative Control
n=15 Participants
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
|
SLS Negative Control
n=14 Participants
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150ppm fluoride as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
|
|---|---|---|---|---|---|
|
AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control
|
42.64 plaque incubation pH*min
Standard Error 3.437
|
34.20 plaque incubation pH*min
Standard Error 3.354
|
28.88 plaque incubation pH*min
Standard Error 3.384
|
2.46 plaque incubation pH*min
Standard Error 3.303
|
31.78 plaque incubation pH*min
Standard Error 3.512
|
SECONDARY outcome
Timeframe: Baseline up to 90 minPopulation: PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.
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.
Outcome measures
| Measure |
Test Zinc-IPMP
n=14 Participants
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
|
Non-SLS Negative Control
n=14 Participants
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
|
Positive Control
n=14 Participants
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100ppm F as stannous fluoride) in 10mL water for 60 sec followed by rinse with 10mL water
|
Non-SLS Negative Control
n=15 Participants
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
|
SLS Negative Control
n=14 Participants
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150ppm fluoride as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
|
|---|---|---|---|---|---|
|
AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control
|
-239.81 regrowth ratio*min
Standard Error 40.122
|
-240.86 regrowth ratio*min
Standard Error 39.118
|
-179.55 regrowth ratio*min
Standard Error 39.415
|
53.66 regrowth ratio*min
Standard Error 38.443
|
-215.08 regrowth ratio*min
Standard Error 40.350
|
SECONDARY outcome
Timeframe: Baseline up to 90 minPopulation: PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.
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.
Outcome measures
| Measure |
Test Zinc-IPMP
n=9 Participants
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
|
Non-SLS Negative Control
n=10 Participants
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
|
Positive Control
n=11 Participants
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100ppm F as stannous fluoride) in 10mL water for 60 sec followed by rinse with 10mL water
|
Non-SLS Negative Control
n=14 Participants
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
|
SLS Negative Control
n=12 Participants
Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150ppm fluoride as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
|
|---|---|---|---|---|---|
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AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control
|
75.23 live:dead stain ratio*min
Standard Error 568.834
|
-691.41 live:dead stain ratio*min
Standard Error 508.108
|
72.19 live:dead stain ratio*min
Standard Error 491.718
|
346.11 live:dead stain ratio*min
Standard Error 431.974
|
-601.87 live:dead stain ratio*min
Standard Error 499.740
|
Adverse Events
Test Zinc-IPMP Toothpaste
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Test Zinc Non- IPMP Toothpaste
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Positive Control Toothpaste
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Non-SLS Negative Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SLS Negative Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Zinc-IPMP Toothpaste
n=44 participants at risk
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
|
Test Zinc Non- IPMP Toothpaste
n=44 participants at risk
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
|
Positive Control Toothpaste
n=45 participants at risk
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
|
Non-SLS Negative Control
n=44 participants at risk
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
|
SLS Negative Control
n=44 participants at risk
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
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
LIP ULCERATION
|
4.5%
2/44
|
0.00%
0/44
|
0.00%
0/45
|
0.00%
0/44
|
0.00%
0/44
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
2.3%
1/44
|
0.00%
0/44
|
0.00%
0/45
|
0.00%
0/44
|
0.00%
0/44
|
|
Gastrointestinal disorders
NAUSEA
|
2.3%
1/44
|
0.00%
0/44
|
0.00%
0/45
|
0.00%
0/44
|
0.00%
0/44
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
2.3%
1/44
|
0.00%
0/44
|
0.00%
0/45
|
0.00%
0/44
|
2.3%
1/44
|
|
Gastrointestinal disorders
TOOTHACHE
|
2.3%
1/44
|
0.00%
0/44
|
0.00%
0/45
|
0.00%
0/44
|
0.00%
0/44
|
|
Gastrointestinal disorders
COATING IN MOUTH
|
0.00%
0/44
|
2.3%
1/44
|
0.00%
0/45
|
0.00%
0/44
|
0.00%
0/44
|
|
Gastrointestinal disorders
GINGIVAL ULCERATION
|
0.00%
0/44
|
2.3%
1/44
|
0.00%
0/45
|
0.00%
0/44
|
0.00%
0/44
|
|
Infections and infestations
RHINITIS
|
2.3%
1/44
|
2.3%
1/44
|
4.4%
2/45
|
4.5%
2/44
|
2.3%
1/44
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/44
|
2.3%
1/44
|
0.00%
0/45
|
0.00%
0/44
|
0.00%
0/44
|
|
Infections and infestations
PERICORONITIS
|
0.00%
0/44
|
2.3%
1/44
|
2.2%
1/45
|
0.00%
0/44
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
TRAUMATIC ULCER
|
2.3%
1/44
|
0.00%
0/44
|
2.2%
1/45
|
0.00%
0/44
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/44
|
2.3%
1/44
|
0.00%
0/45
|
0.00%
0/44
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/44
|
0.00%
0/44
|
2.2%
1/45
|
0.00%
0/44
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
SUPERFICIAL INJURY OF EYE
|
0.00%
0/44
|
0.00%
0/44
|
2.2%
1/45
|
0.00%
0/44
|
0.00%
0/44
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.00%
0/44
|
0.00%
0/44
|
0.00%
0/45
|
0.00%
0/44
|
2.3%
1/44
|
|
Nervous system disorders
HEADACHE
|
2.3%
1/44
|
0.00%
0/44
|
2.2%
1/45
|
2.3%
1/44
|
0.00%
0/44
|
|
General disorders
DEVICE FAILURE
|
0.00%
0/44
|
0.00%
0/44
|
0.00%
0/45
|
0.00%
0/44
|
2.3%
1/44
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/44
|
0.00%
0/44
|
4.4%
2/45
|
0.00%
0/44
|
0.00%
0/44
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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