Trial Outcomes & Findings for A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population (NCT NCT04950465)

Last Updated: 2023-10-23

Results Overview

Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participants were scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.

Recruitment status

COMPLETED

Study phase

Target enrollment

271 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2023-10-23

Participant Flow

Participants were recruited from one center in China.

A total of 561 participates were screened, out of which 271 participants were enrolled and 197 participates were randomized to a treatment (66 participants in the test product group, 67 participants in the negative control dentifrice group and 64 participants in the positive control dentifrice group) and 196 participants subsequently completed the study; 1 participant did not complete the study from the test product group due to being lost to follow-up.

Participant milestones

Participant milestones
Measure	Test Dentifrice (Sensodyne Sensitivity & Gum) Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided, followed by brushing of the qualifying sensitive teeth. Following brushing they were instructed to rinse once with 10 milliliters (mL) of water from the rinsing cup provided.	Negative Control (Crest Cavity Protection Fresh Lime) Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.	Positive Control (Sensodyne Repair and Protect) Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.
Overall Study STARTED	66	67	64
Overall Study COMPLETED	65	67	64
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Dentifrice (Sensodyne Sensitivity & Gum) Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided, followed by brushing of the qualifying sensitive teeth. Following brushing they were instructed to rinse once with 10 milliliters (mL) of water from the rinsing cup provided.	Negative Control (Crest Cavity Protection Fresh Lime) Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.	Positive Control (Sensodyne Repair and Protect) Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity in a Chinese Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Dentifrice (Sensodyne Sensitivity & Gum) n=65 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided, followed by brushing of the qualifying sensitive teeth. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.	Negative Control (Crest Cavity Protection Fresh Lime) n=67 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.	Positive Control (Sensodyne Repair and Protect) n=64 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.	Total n=196 Participants Total of all reporting groups
Age, Continuous	43.9 years STANDARD_DEVIATION 8.04 • n=5 Participants	42.7 years STANDARD_DEVIATION 8.55 • n=7 Participants	42.4 years STANDARD_DEVIATION 9.68 • n=5 Participants	43.0 years STANDARD_DEVIATION 8.76 • n=4 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	64 Participants n=7 Participants	56 Participants n=5 Participants	177 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	65 Participants n=5 Participants	67 Participants n=7 Participants	64 Participants n=5 Participants	196 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: mITT population

Outcome measures

Outcome measures
Measure	Test Dentifrice (Sensodyne Sensitivity & Gum) n=65 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided, followed by brushing of the qualifying sensitive teeth. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.	Negative Control (Crest Cavity Protection Fresh Lime) n=67 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.
Change From Baseline in Schiff Sensitivity Score at Week 8 (Test Dentifrice Versus [vs.] Negative Control)	-0.98 Score on a scale Standard Error 0.099	-1.14 Score on a scale Standard Error 0.098

SECONDARY outcome

Timeframe: Baseline, Week 4 and 8

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

Constant pressure was administered using Yeaple Probe. At baseline the upper test limit was 20 gram (g) and at Week 4 and 8, the upper test limit was 80g. The tactile threshold was the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth were determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutives 'yes' responses were recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.

Outcome measures

Outcome measures
Measure	Test Dentifrice (Sensodyne Sensitivity & Gum) n=65 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided, followed by brushing of the qualifying sensitive teeth. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.	Negative Control (Crest Cavity Protection Fresh Lime) n=67 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.
Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control) Week 4	9.22 grams Standard Error 1.577	7.42 grams Standard Error 1.538
Change From Baseline in Tactile Threshold at Week 4 and 8 (Test Dentifrice vs. Negative Control) Week 8	16.63 grams Standard Error 2.393	11.82 grams Standard Error 2.353

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.

Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of 2 selected test teeth, response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. Higher score indicates worst outcome (more sensitivity). Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.

Outcome measures

Outcome measures
Measure	Test Dentifrice (Sensodyne Sensitivity & Gum) n=64 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided, followed by brushing of the qualifying sensitive teeth. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.	Negative Control (Crest Cavity Protection Fresh Lime) n=67 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.
Change From Baseline in Schiff Sensitivity Score at Week 4 (Test Dentifrice vs. Negative Control)	-0.79 Score on a scale Standard Error 0.082	-0.75 Score on a scale Standard Error 0.080

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 8

Population: mITT population

Outcome measures

Outcome measures
Measure	Test Dentifrice (Sensodyne Sensitivity & Gum) n=64 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided, followed by brushing of the qualifying sensitive teeth. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.	Negative Control (Crest Cavity Protection Fresh Lime) n=67 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.
Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control) Week 4	-0.76 score on a scale Standard Error 0.082	-0.75 score on a scale Standard Error 0.080
Change From Baseline in Schiff Sensitivity Score at Week 4 and 8 (Positive Control vs. Negative Control) Week 8	-0.99 score on a scale Standard Error 0.100	-1.14 score on a scale Standard Error 0.098

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 8

Population: mITT population

Constant pressure was administered using Yeaple Probe. At baseline the upper test limit was 20g and at Week 4 and 8, the upper test limit was 80g. The tactile threshold was the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutives 'yes' responses would be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth. Change from baseline was defined as post dose visit value minus baseline visit value. Baseline was defined as Day 1 (visit 2) value.

Outcome measures

Outcome measures
Measure	Test Dentifrice (Sensodyne Sensitivity & Gum) n=64 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided, followed by brushing of the qualifying sensitive teeth. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.	Negative Control (Crest Cavity Protection Fresh Lime) n=67 Participants Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.
Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control) Week 8	11.05 grams Standard Error 2.412	11.82 grams Standard Error 2.353
Change From Baseline in Tactile Threshold at Week 4 and 8 (Positive Control vs. Negative Control) Week 4	4.59 grams Standard Error 1.577	7.42 grams Standard Error 1.538

Adverse Events

Test Dentifrice (Sensodyne Sensitivity & Gum)

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Negative Control (Crest Cavity Protection Fresh Lime)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Positive Control (Sensodyne Repair and Protect)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test Dentifrice (Sensodyne Sensitivity & Gum) n=66 participants at risk Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided, followed by brushing of the qualifying sensitive teeth. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.	Negative Control (Crest Cavity Protection Fresh Lime) n=67 participants at risk Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.	Positive Control (Sensodyne Repair and Protect) n=64 participants at risk Participants were instructed to brush their teeth for 1 timed minute with full ribbon of toothpaste on the head of the toothbrush provided. Following brushing they were instructed to rinse once with 10 mL of water from the rinsing cup provided.
Gastrointestinal disorders Obstructive pancreatitis	1.5% 1/66 • From start of screening until end of study (up to Day 57+/-3) An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.	0.00% 0/67 • From start of screening until end of study (up to Day 57+/-3) An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.	0.00% 0/64 • From start of screening until end of study (up to Day 57+/-3) An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.
Hepatobiliary disorders Cholecystitis	1.5% 1/66 • From start of screening until end of study (up to Day 57+/-3) An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.	0.00% 0/67 • From start of screening until end of study (up to Day 57+/-3) An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.	0.00% 0/64 • From start of screening until end of study (up to Day 57+/-3) An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) is a particular category of an adverse event where the adverse outcome is serious.

Other adverse events

Additional Information

Haleon Response Center

HALEON

Phone: +44 7880 182593

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON 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