Trial Outcomes & Findings for A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity (NCT NCT03965039)

NCT ID: NCT03965039

Last Updated: 2020-10-30

Results Overview

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2020-10-30

Participant Flow

Participant milestones

Measure	Marketed Stannous Fluoride Toothpaste Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Overall Study STARTED	30	30	30	30
Overall Study COMPLETED	30	29	30	29
Overall Study NOT COMPLETED	0	1	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity

Baseline characteristics by cohort

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=30 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=30 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=30 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste	Total n=120 Participants Total of all reporting groups
Age, Continuous	38.73 years STANDARD_DEVIATION 11.52 • n=5 Participants	42.53 years STANDARD_DEVIATION 13.28 • n=7 Participants	39.03 years STANDARD_DEVIATION 11.04 • n=5 Participants	39.87 years STANDARD_DEVIATION 10.42 • n=4 Participants	40.04 years STANDARD_DEVIATION 11.56 • n=21 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	21 Participants n=7 Participants	21 Participants n=5 Participants	22 Participants n=4 Participants	86 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	34 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	25 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	23 Participants n=7 Participants	24 Participants n=5 Participants	23 Participants n=4 Participants	95 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	19 Participants n=21 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	24 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	74 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	16 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

Outcome measures

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=30 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=30 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=28 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Air Challenge	1.17 score on a scale Standard Error 0.141	1.48 score on a scale Standard Error 0.087	2.26 score on a scale Standard Error 0.066	1.39 score on a scale Standard Error 0.116

SECONDARY outcome

Timeframe: Baseline

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth.

Outcome measures

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=30 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=30 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=30 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Baseline Air Challenge	2.45 score on a scale Standard Deviation 0.379	2.40 score on a scale Standard Deviation 0.381	2.52 score on a scale Standard Deviation 0.382	2.45 score on a scale Standard Deviation 0.356

SECONDARY outcome

Timeframe: 3 days

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

Outcome measures

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=30 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=29 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=30 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Air Challenge	1.93 score on a scale Standard Error 0.081	2.05 score on a scale Standard Error 0.085	2.36 score on a scale Standard Error 0.062	1.88 score on a scale Standard Error 0.085

SECONDARY outcome

Timeframe: 2 weeks

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

Outcome measures

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=30 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=30 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=29 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Air Challenge	1.44 score on a scale Standard Error 0.117	1.78 score on a scale Standard Error 0.092	2.24 score on a scale Standard Error 0.074	1.61 score on a scale Standard Error 0.103

SECONDARY outcome

Timeframe: 8 weeks

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

Outcome measures

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=29 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=30 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=29 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Air Challenge	0.96 score on a scale Standard Error 0.144	1.24 score on a scale Standard Error 0.094	2.22 score on a scale Standard Error 0.059	1.18 score on a scale Standard Error 0.134

SECONDARY outcome

Timeframe: 11 weeks

The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluophosphate toothpaste (from week 8 to week 11).

Outcome measures

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=29 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=30 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=29 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Air Challenge	1.32 score on a scale Standard Error 0.147	1.40 score on a scale Standard Error 0.121	2.18 score on a scale Standard Error 0.071	1.32 score on a scale Standard Error 0.145

SECONDARY outcome

Timeframe: Baseline

Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form.

Outcome measures

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=30 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=30 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=30 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Baseline Yeaple Probe	10.33 score on a scale Standard Deviation 1.826	10.50 score on a scale Standard Deviation 1.526	11.00 score on a scale Standard Deviation 2.754	10.50 score on a scale Standard Deviation 2.013

SECONDARY outcome

Timeframe: 3 days

Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

Outcome measures

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=30 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=29 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=30 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Tactile Threshold	16.70 score on a scale Standard Error 1.039	13.74 score on a scale Standard Error 0.704	12.41 score on a scale Standard Error 0.741	15.90 score on a scale Standard Error 1.240

SECONDARY outcome

Timeframe: 2 weeks

Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

Outcome measures

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=30 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=30 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=29 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Tactile Threshold	22.70 score on a scale Standard Error 1.987	18.57 score on a scale Standard Error 1.528	14.17 score on a scale Standard Error 1.022	21.61 score on a scale Standard Error 1.533

SECONDARY outcome

Timeframe: 4 weeks

Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

Outcome measures

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=30 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=30 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=28 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Tactile Threshold	26.76 score on a scale Standard Error 2.548	22.76 score on a scale Standard Error 1.710	13.93 score on a scale Standard Error 0.988	25.06 score on a scale Standard Error 1.556

SECONDARY outcome

Timeframe: 8 weeks

Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure.

Outcome measures

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=29 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=30 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=29 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Tactile Threshold	29.30 score on a scale Standard Error 2.728	27.45 score on a scale Standard Error 1.926	13.45 score on a scale Standard Error 0.824	28.49 score on a scale Standard Error 2.044

SECONDARY outcome

Timeframe: 11 weeks

Tactile Threshold will be measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form. The least square mean will be calculated for this measure. All subjects will have been on three weeks use of a marketed sodium monofluorophosphate toothpaste (from week 8 to week 11).

Outcome measures

Measure	Marketed Stannous Fluoride Toothpaste n=30 Participants Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=29 Participants Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=30 Participants Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=29 Participants Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Tactile Threshold	24.75 score on a scale Standard Error 2.631	21.92 score on a scale Standard Error 1.801	12.71 score on a scale Standard Error 0.664	24.85 score on a scale Standard Error 1.863

Adverse Events

Marketed Stannous Fluoride Toothpaste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Marketed Potassium Nitrate Toothpaste

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Marketed Sodium Monofluorophosphate Toothpaste

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental Dipotassium Oxalate Toothpaste

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Marketed Stannous Fluoride Toothpaste n=30 participants at risk Brush twice daily Stannous fluoride toothpaste: Marketed stannous fluoride (0.454%) toothpaste	Marketed Potassium Nitrate Toothpaste n=30 participants at risk Brush Twice Daily Potassium nitrate toothpaste: Marketed potassium nitrate (5%) toothpaste	Marketed Sodium Monofluorophosphate Toothpaste n=30 participants at risk Brush Twice Daily Sodium monofluorophosphate toothpaste: Marketed sodium monofluorophosphate (0.76%) toothpaste	Experimental Dipotassium Oxalate Toothpaste n=30 participants at risk Brush Twice Daily Dipotassium oxalate toothpaste: Experimental dipotassium oxalate (3%) toothpaste
Gastrointestinal disorders Desquamation Mouth	0.00% 0/30 • Adverse event data were collected for all 11 weeks of the study for each intervention.	3.3% 1/30 • Adverse event data were collected for all 11 weeks of the study for each intervention.	0.00% 0/30 • Adverse event data were collected for all 11 weeks of the study for each intervention.	3.3% 1/30 • Adverse event data were collected for all 11 weeks of the study for each intervention.
Gastrointestinal disorders Mouth Injury	0.00% 0/30 • Adverse event data were collected for all 11 weeks of the study for each intervention.	13.3% 4/30 • Adverse event data were collected for all 11 weeks of the study for each intervention.	0.00% 0/30 • Adverse event data were collected for all 11 weeks of the study for each intervention.	10.0% 3/30 • Adverse event data were collected for all 11 weeks of the study for each intervention.

Additional Information

Clinical Trial Manager

Procter and Gamble

Phone: 513-622-2489

Email: peters.j.2@pg.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI should disclose plans to sponsor prior to public release.
• Publication restrictions are in place

Restriction type: OTHER