Trial · NCT03965039

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

NCT03965039, Not applicable, Completed, Procter and Gamble; results first posted 2020-10-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity. Trials, record NCT03965039. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03965039

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
NCT number: NCT03965039
Status: Completed
Phases: Not applicable
Enrollment: 120 participants, actual
Lead sponsor: Procter and Gamble
Conditions: Dentin Hypersensitivity
Interventions: Dipotassium oxalate toothpaste, Stannous fluoride toothpaste, Potassium nitrate toothpaste, Sodium monofluorophosphate toothpaste
First posted: 2019-05-28
Last updated: 2020-10-30
Results first posted: 2020-10-30

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Air Challenge	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.
Secondary	Baseline Air Challenge	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.
Secondary	Air Challenge	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.
Secondary	Air Challenge	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.
Secondary	Air Challenge	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.
Secondary	Air Challenge	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).
Secondary	Baseline Yeaple Probe	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.
Secondary	Tactile Threshold	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.
Secondary	Tactile Threshold	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.
Secondary	Tactile Threshold	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.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Air Challenge	4 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Baseline Air Challenge	Baseline	score on a scale	MEAN
SECONDARY	Air Challenge	3 days	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Air Challenge	2 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Air Challenge	8 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Air Challenge	11 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Baseline Yeaple Probe	Baseline	score on a scale	MEAN
SECONDARY	Tactile Threshold	3 days	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Tactile Threshold	2 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Tactile Threshold	4 weeks	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Air Challenge	Marketed Stannous Fluoride Toothpaste	1.17	Standard Error 0.141	score on a scale
Air Challenge	Marketed Potassium Nitrate Toothpaste	1.48	Standard Error 0.087	score on a scale
Air Challenge	Marketed Sodium Monofluorophosphate Toothpaste	2.26	Standard Error 0.066	score on a scale
Air Challenge	Experimental Dipotassium Oxalate Toothpaste	1.39	Standard Error 0.116	score on a scale
Baseline Air Challenge	Marketed Stannous Fluoride Toothpaste	2.45	Standard Deviation 0.379	score on a scale
Baseline Air Challenge	Marketed Potassium Nitrate Toothpaste	2.40	Standard Deviation 0.381	score on a scale
Baseline Air Challenge	Marketed Sodium Monofluorophosphate Toothpaste	2.52	Standard Deviation 0.382	score on a scale
Baseline Air Challenge	Experimental Dipotassium Oxalate Toothpaste	2.45	Standard Deviation 0.356	score on a scale
Air Challenge	Marketed Stannous Fluoride Toothpaste	1.93	Standard Error 0.081	score on a scale
Air Challenge	Marketed Potassium Nitrate Toothpaste	2.05	Standard Error 0.085	score on a scale

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Marketed Stannous Fluoride Toothpaste	30
Overall Study	STARTED	Marketed Potassium Nitrate Toothpaste	30
Overall Study	STARTED	Marketed Sodium Monofluorophosphate Toothpaste	30
Overall Study	STARTED	Experimental Dipotassium Oxalate Toothpaste	30
Overall Study	COMPLETED	Marketed Stannous Fluoride Toothpaste	30
Overall Study	COMPLETED	Marketed Potassium Nitrate Toothpaste	29
Overall Study	COMPLETED	Marketed Sodium Monofluorophosphate Toothpaste	30
Overall Study	COMPLETED	Experimental Dipotassium Oxalate Toothpaste	29
Overall Study	NOT COMPLETED	Marketed Stannous Fluoride Toothpaste	0
Overall Study	NOT COMPLETED	Marketed Potassium Nitrate Toothpaste	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Desquamation Mouth	Gastrointestinal disorders	Marketed Stannous Fluoride Toothpaste	0	30
other	Desquamation Mouth	Gastrointestinal disorders	Marketed Potassium Nitrate Toothpaste	1	30
other	Desquamation Mouth	Gastrointestinal disorders	Marketed Sodium Monofluorophosphate Toothpaste	0	30
other	Desquamation Mouth	Gastrointestinal disorders	Experimental Dipotassium Oxalate Toothpaste	1	30
other	Mouth Injury	Gastrointestinal disorders	Marketed Stannous Fluoride Toothpaste	0	30
other	Mouth Injury	Gastrointestinal disorders	Marketed Potassium Nitrate Toothpaste	4	30
other	Mouth Injury	Gastrointestinal disorders	Marketed Sodium Monofluorophosphate Toothpaste	0	30
other	Mouth Injury	Gastrointestinal disorders	Experimental Dipotassium Oxalate Toothpaste	3	30

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Marketed Stannous Fluoride Toothpaste	0	30
Total, all-cause mortality	Marketed Potassium Nitrate Toothpaste	0	30
Total, all-cause mortality	Marketed Sodium Monofluorophosphate Toothpaste	0	30
Total, all-cause mortality	Experimental Dipotassium Oxalate Toothpaste	0	30
Total, other adverse events	Marketed Stannous Fluoride Toothpaste	0	30
Total, other adverse events	Marketed Potassium Nitrate Toothpaste	5	30
Total, other adverse events	Marketed Sodium Monofluorophosphate Toothpaste	0	30
Total, other adverse events	Experimental Dipotassium Oxalate Toothpaste	3	30
Total, serious adverse events	Marketed Stannous Fluoride Toothpaste	0	30
Total, serious adverse events	Marketed Potassium Nitrate Toothpaste	0	30

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40444818	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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