Trial Outcomes & Findings for To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms (NCT NCT02207400)
NCT ID: NCT02207400
Last Updated: 2018-07-31
Results Overview
The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
COMPLETED
PHASE2
246 participants
24 weeks
2018-07-31
Participant Flow
The participants were recruited at a clinical site in the USA.
Participant milestones
| Measure |
Sodium Bicarbonate and Sodium Fluoride Dentifrice
Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
Sodium Fluoride Dentifrice
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
123
|
|
Overall Study
COMPLETED
|
107
|
109
|
|
Overall Study
NOT COMPLETED
|
16
|
14
|
Reasons for withdrawal
| Measure |
Sodium Bicarbonate and Sodium Fluoride Dentifrice
Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
Sodium Fluoride Dentifrice
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
|
Overall Study
Positive Urine Pregnancy Test
|
0
|
1
|
Baseline Characteristics
To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
Baseline characteristics by cohort
| Measure |
Sodium Bicarbonate and Sodium Fluoride Dentifrice
n=123 Participants
Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
Sodium Fluoride Dentifrice
n=123 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.39 Years
STANDARD_DEVIATION 14.284 • n=5 Participants
|
37.77 Years
STANDARD_DEVIATION 12.615 • n=7 Participants
|
38.58 Years
STANDARD_DEVIATION 13.473 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
Outcome measures
| Measure |
Sodium Bicarbonate and Sodium Fluoride Dentifrice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
Sodium Fluoride Dentifrice
n=117 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Number of Gingival Bleeding Sites at 24 Weeks
|
13.24 Number of bleeding sites
Standard Deviation 7.663
|
24.90 Number of bleeding sites
Standard Deviation 9.044
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
Outcome measures
| Measure |
Sodium Bicarbonate and Sodium Fluoride Dentifrice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
Sodium Fluoride Dentifrice
n=117 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Modified Gingival Index (MGI) at 24 Weeks
|
1.26 Units on a scale
Standard Deviation 0.505
|
1.93 Units on a scale
Standard Deviation 0.408
|
SECONDARY outcome
Timeframe: Baseline, 6 and 12 weeksPopulation: ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
Outcome measures
| Measure |
Sodium Bicarbonate and Sodium Fluoride Dentifrice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
Sodium Fluoride Dentifrice
n=117 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Number of Gingival Bleeding Sites at 6 and 12 Weeks
Number of Bleeding Sites at 6 weeks
|
12.26 Number of bleeding sites
Standard Deviation 9.339
|
23.23 Number of bleeding sites
Standard Deviation 10.993
|
|
Number of Gingival Bleeding Sites at 6 and 12 Weeks
Number of Bleeding Sites at 12 weeks
|
15.73 Number of bleeding sites
Standard Deviation 7.632
|
23.86 Number of bleeding sites
Standard Deviation 9.265
|
|
Number of Gingival Bleeding Sites at 6 and 12 Weeks
Number of Bleeding Sites at Baseline
|
29.76 Number of bleeding sites
Standard Deviation 8.238
|
29.05 Number of bleeding sites
Standard Deviation 8.390
|
SECONDARY outcome
Timeframe: 6 and 12 weeksPopulation: ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
Outcome measures
| Measure |
Sodium Bicarbonate and Sodium Fluoride Dentifrice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
Sodium Fluoride Dentifrice
n=117 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Modified Gingival Index (MGI)) at 6 and 12 Weeks.
MGI at 12 weeks
|
1.50 Units on a scale
Standard Deviation 0.536
|
1.94 Units on a scale
Standard Deviation 0.464
|
|
Modified Gingival Index (MGI)) at 6 and 12 Weeks.
MGI at 6 weeks
|
1.50 Units on a scale
Standard Deviation 0.567
|
1.96 Units on a scale
Standard Deviation 0.427
|
SECONDARY outcome
Timeframe: 6, 12 and 24 weeksPopulation: ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
Outcome measures
| Measure |
Sodium Bicarbonate and Sodium Fluoride Dentifrice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
Sodium Fluoride Dentifrice
n=117 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Bleeding Index (BI) at 6, 12 and 24 Weeks
BI Score Score at 12 weeks
|
0.19 Units on a Scale
Standard Deviation 0.112
|
0.28 Units on a Scale
Standard Deviation 0.135
|
|
Bleeding Index (BI) at 6, 12 and 24 Weeks
BI Score Score at 24 weeks
|
0.17 Units on a Scale
Standard Deviation 0.116
|
0.31 Units on a Scale
Standard Deviation 0.159
|
|
Bleeding Index (BI) at 6, 12 and 24 Weeks
BI Score Score at 6 weeks
|
0.15 Units on a Scale
Standard Deviation 0.133
|
0.30 Units on a Scale
Standard Deviation 0.172
|
SECONDARY outcome
Timeframe: 6, 12 and 24 weeksPopulation: ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.
Outcome measures
| Measure |
Sodium Bicarbonate and Sodium Fluoride Dentifrice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
Sodium Fluoride Dentifrice
n=112 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.
Overall Plaque Score at 6 weeks
|
2.56 Units on a scale
Standard Deviation 0.536
|
3.01 Units on a scale
Standard Deviation 0.411
|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.
Interproximal Plaque Score at 12 weeks
|
2.76 Units on a scale
Standard Deviation 0.437
|
3.10 Units on a scale
Standard Deviation 0.311
|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.
Interproximal Plaque Score at 24 weeks
|
2.71 Units on a scale
Standard Deviation 0.390
|
3.11 Units on a scale
Standard Deviation 0.336
|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.
Overall Plaque Score at 12 weeks
|
2.54 Units on a scale
Standard Deviation 0.495
|
2.90 Units on a scale
Standard Deviation 0.374
|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.
Overall Plaque Score at 24 weeks
|
2.47 Units on a scale
Standard Deviation 0.437
|
2.92 Units on a scale
Standard Deviation 0.399
|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.
Interproximal Plaque Score at 6 weeks
|
2.78 Units on a scale
Standard Deviation 0.492
|
3.19 Units on a scale
Standard Deviation 0.351
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, 24 and 32 weeksPopulation: ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours).
Outcome measures
| Measure |
Sodium Bicarbonate and Sodium Fluoride Dentifrice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
Sodium Fluoride Dentifrice
n=117 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Yeast Count at Baseline (n=24, 26)
|
203.4 colony forming units per sample
Standard Deviation 842.28
|
647.8 colony forming units per sample
Standard Deviation 2958.78
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Yeast Count at 6 weeks (n=23, 26)
|
287.3 colony forming units per sample
Standard Deviation 1014.31
|
784.3 colony forming units per sample
Standard Deviation 1796.75
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Yeast Count at 12 weeks (n=24, 25)
|
668.9 colony forming units per sample
Standard Deviation 812.81
|
411.3 colony forming units per sample
Standard Deviation 906.19
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Staph Count at Baseline (n=24, 26)
|
0.2 colony forming units per sample
Standard Deviation 0.82
|
0.2 colony forming units per sample
Standard Deviation 0.86
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Steph Count at 6 weeks (n=24, 26)
|
0.1 colony forming units per sample
Standard Deviation 0.34
|
0 colony forming units per sample
Standard Deviation 0.20
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Steph Count at 12 weeks (n=24, 26)
|
1.8 colony forming units per sample
Standard Deviation 7.10
|
3.2 colony forming units per sample
Standard Deviation 15.47
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Steph Count at 24 weeks (n=23, 25)
|
0.6 colony forming units per sample
Standard Deviation 1.59
|
0.2 colony forming units per sample
Standard Deviation 0.37
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Steph Count at 32 weeks (n=21, 21)
|
0.2 colony forming units per sample
Standard Deviation 0.51
|
0.1 colony forming units per sample
Standard Deviation 0.36
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Yeast Count at 24 weeks (n=17, 22)
|
1479.6 colony forming units per sample
Standard Deviation 1165.48
|
1522.3 colony forming units per sample
Standard Deviation 1008.13
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Yeast Count at 32 weeks (n= 14, 14)
|
2743.5 colony forming units per sample
Standard Deviation 2505.75
|
1206.4 colony forming units per sample
Standard Deviation 1008.34
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Coliform count at Baseline (n= 24, 26)
|
3.9 colony forming units per sample
Standard Deviation 8.82
|
3.8 colony forming units per sample
Standard Deviation 8.27
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Coliform count at 6 weeks (n= 24, 26)
|
2.6 colony forming units per sample
Standard Deviation 6.72
|
5.7 colony forming units per sample
Standard Deviation 20.05
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Coliform count at 12 weeks (n= 24, 26)
|
10.9 colony forming units per sample
Standard Deviation 14.65
|
26.9 colony forming units per sample
Standard Deviation 78.47
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Coliform count at 24 weeks (n=23, 25)
|
8.1 colony forming units per sample
Standard Deviation 16.86
|
12.6 colony forming units per sample
Standard Deviation 19.24
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Coliform count at 32 weeks (n=21, 21)
|
10.9 colony forming units per sample
Standard Deviation 16.17
|
17.8 colony forming units per sample
Standard Deviation 29.84
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
E. Coli count at Baseline (n=24, 26)
|
0 colony forming units per sample
Standard Deviation 0
|
0 colony forming units per sample
Standard Deviation 0.20
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
E. Coli count at 6 weeks (n=24, 26)
|
0.1 colony forming units per sample
Standard Deviation 0.28
|
0 colony forming units per sample
Standard Deviation 0.20
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
E. Coli count at 12 weeks (n=24, 26)
|
0.1 colony forming units per sample
Standard Deviation 0.28
|
0 colony forming units per sample
Standard Deviation 0
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
E. Coli count at 24 weeks (n=23, 25)
|
0.3 colony forming units per sample
Standard Deviation 1.25
|
0.2 colony forming units per sample
Standard Deviation 0.55
|
|
Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
E. Coli count at 32 weeks (n=21, 21)
|
0.6 colony forming units per sample
Standard Deviation 1.29
|
0 colony forming units per sample
Standard Deviation 0.22
|
Adverse Events
Sodium Bicarbonate and Sodium Fluoride Dentifrice
Sodium Fluoride Dentifrice
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sodium Bicarbonate and Sodium Fluoride Dentifrice
n=123 participants at risk
Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride
|
Sodium Fluoride Dentifrice
n=123 participants at risk
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Infections and infestations
Cellulitis Orbital
|
1.6%
2/123 • Number of events 2 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.81%
1/123 • Number of events 2 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Infections and infestations
Pneumonia
|
1.6%
2/123 • Number of events 2 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Infections and infestations
GASTROENTERITIS
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Infections and infestations
PULPITIS DENTAL
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Injury, poisoning and procedural complications
MOUTH INJURY
|
3.3%
4/123 • Number of events 4 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Injury, poisoning and procedural complications
TRAUMATIC ULCER
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
2.4%
3/123 • Number of events 4 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Gastrointestinal disorders
CHEILITIS
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.81%
1/123 • Number of events 2 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Gastrointestinal disorders
SENSITIVITY OF TEETH
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Gastrointestinal disorders
GINGIVAL ULCERATION
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Gastrointestinal disorders
TONGUE ULCERATION
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Nervous system disorders
BURNING SENSATION
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/123 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
0.81%
1/123 • Number of events 1 • Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
|
Additional Information
GSK Response Center
GlaxoSmithKline
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