Trial Outcomes & Findings for An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining (NCT NCT01962493)
NCT ID: NCT01962493
Last Updated: 2015-03-03
Results Overview
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
160 participants
Primary outcome timeframe
Week 6 post treatment administration
Results posted on
2015-03-03
Participant Flow
The study was conducted at two sites in the UK. Participants were recruited from the site's database and by use of advertisements.
In total 314 participants were screened and 160 participants were randomised of whom 150 completed the study. Of the 10 participants that did not completed the study, 3 had adverse events; 1 had protocol violation and 6 had withdrawal of consent.
Participant milestones
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
82
|
|
Overall Study
COMPLETED
|
73
|
77
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining
Baseline characteristics by cohort
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=78 Participants
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=82 Participants
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.8 Years
STANDARD_DEVIATION 11.08 • n=99 Participants
|
39.5 Years
STANDARD_DEVIATION 10.87 • n=107 Participants
|
39.6 Years
STANDARD_DEVIATION 10.94 • n=206 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 6 post treatment administrationPopulation: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Outcome measures
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=75 Participants
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=79 Participants
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|---|---|---|
|
Modified Lobene Stain Index (MLSI) at Week 6
|
0.97 Score on a Scale
Standard Deviation 0.929
|
1.22 Score on a Scale
Standard Deviation 1.008
|
SECONDARY outcome
Timeframe: Week 3 post treatment administrationPopulation: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Outcome measures
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=75 Participants
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=79 Participants
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|---|---|---|
|
Overall MLSI at Week 3
|
0.46 Score on a Scale
Standard Deviation 0.572
|
0.59 Score on a Scale
Standard Deviation 0.563
|
SECONDARY outcome
Timeframe: Week 3 post treatment administrationPopulation: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Outcome measures
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=75 Participants
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=79 Participants
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|---|---|---|
|
Overall Facial MLSI at Week 3
|
0.27 Score on a Scale
Standard Deviation 0.557
|
0.41 Score on a Scale
Standard Deviation 0.542
|
SECONDARY outcome
Timeframe: Week 6 post treatment administrationPopulation: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Outcome measures
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=75 Participants
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=79 Participants
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|---|---|---|
|
Overall Facial MLSI at Week 6
|
0.67 Score on a Scale
Standard Deviation 0.885
|
0.96 Score on a Scale
Standard Deviation 0.992
|
SECONDARY outcome
Timeframe: Week 3 post treatment administrationPopulation: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Outcome measures
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=75 Participants
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=79 Participants
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|---|---|---|
|
Overall Interproximal MLSI at Week 3
|
0.66 Score on a Scale
Standard Deviation 0.828
|
0.87 Score on a Scale
Standard Deviation 0.820
|
SECONDARY outcome
Timeframe: Week 6 post treatment administrationPopulation: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Outcome measures
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=75 Participants
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=79 Participants
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|---|---|---|
|
Overall Interproximal MLSI at Week 6
|
1.44 Score on a Scale
Standard Deviation 1.396
|
1.87 Score on a Scale
Standard Deviation 1.525
|
SECONDARY outcome
Timeframe: Week 3 post treatment administrationPopulation: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Outcome measures
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=75 Participants
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=79 Participants
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|---|---|---|
|
Overall Gingival and Interproximal MLSI at Week 3
|
0.56 Score on a Scale
Standard Deviation 0.713
|
0.73 Score on a Scale
Standard Deviation 0.711
|
SECONDARY outcome
Timeframe: Week 6 post treatment administrationPopulation: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Outcome measures
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=75 Participants
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=79 Participants
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|---|---|---|
|
Overall Gingival and Interproximal MLSI at Week 6
|
1.18 Score on a Scale
Standard Deviation 1.134
|
1.52 Score on a Scale
Standard Deviation 1.271
|
Adverse Events
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=78 participants at risk
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=82 participants at risk
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Reproductive system and breast disorders
Ruptured Ovarian Cyst
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
Other adverse events
| Measure |
NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=78 participants at risk
Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
NaF Toothpaste + Chlorhexidine Digluconate Mouthwash
n=82 participants at risk
Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
|
|---|---|---|
|
Gastrointestinal disorders
Paraesthesia oral
|
3.8%
3/78 • Number of events 3 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
4.9%
4/82 • Number of events 4 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Glossodynia
|
2.6%
2/78 • Number of events 2 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
3.7%
3/82 • Number of events 4 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 3 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
2.6%
2/78 • Number of events 2 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
2.4%
2/82 • Number of events 2 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Tongue discolouration
|
5.1%
4/78 • Number of events 4 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
2.4%
2/82 • Number of events 3 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
2/78 • Number of events 2 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
2.4%
2/82 • Number of events 2 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Gingival pain
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Gastrointestinal disorders
Oral mucosal hypertrophy
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Nervous system disorders
Headache
|
16.7%
13/78 • Number of events 14 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
7.3%
6/82 • Number of events 9 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Nervous system disorders
Dysgeusia
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
8.5%
7/82 • Number of events 7 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Nervous system disorders
Tension headache
|
5.1%
4/78 • Number of events 6 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Nervous system disorders
Ageusia
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
2.4%
2/82 • Number of events 2 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Infections and infestations
Upper respiratory tract infection
|
11.5%
9/78 • Number of events 9 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
9.8%
8/82 • Number of events 8 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
3.7%
3/82 • Number of events 3 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Infections and infestations
Oral herpes
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
2.4%
2/82 • Number of events 2 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Infections and infestations
Appendicitis
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Infections and infestations
Influenza
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Infections and infestations
Sinusitis
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Infections and infestations
Tooth abscess
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Injury, poisoning and procedural complications
Thermal burn
|
3.8%
3/78 • Number of events 4 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
3.7%
3/82 • Number of events 3 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Injury, poisoning and procedural complications
Mouth injury
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
2.4%
2/82 • Number of events 2 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.6%
2/78 • Number of events 2 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.6%
2/78 • Number of events 2 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
General disorders
Device failure
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
General disorders
Cyst rupture
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.3%
1/78 • Number of events 2 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
1.3%
1/78 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
0.00%
0/82 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/78 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
1.2%
1/82 • Number of events 1 • Adverse events were collected from the start of the washout period, and until five days following last administration of the investigational product
|
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