Trial Outcomes & Findings for The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity(DH) (NCT NCT02751450)

Last Updated: 2017-05-17

Results Overview

The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.

Recruitment status

COMPLETED

Study phase

Target enrollment

263 participants

Primary outcome timeframe

Baseline to Day 3

Results posted on

2017-05-17

Participant Flow

Participants were recruited at one center in United Kingdom.

A total of 263 participants were screened, 233 were randomized and 232 completed the study. One participant withdrew from study due to adverse event (AE).

Participant milestones

Participant milestones
Measure	Stannous Fluoride Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million, ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.	Sodium Monofluorophosphate Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
Overall Study STARTED	117	116
Overall Study COMPLETED	116	116
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Stannous Fluoride Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million, ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.	Sodium Monofluorophosphate Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
Overall Study Adverse Event	1	0

Baseline Characteristics

The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity(DH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stannous Fluoride n=117 Participants Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.	Sodium Monofluorophosphate n=116 Participants Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.	Total n=233 Participants Total of all reporting groups
Age, Continuous	34.3 Years STANDARD_DEVIATION 12.92 • n=5 Participants	32.8 Years STANDARD_DEVIATION 11.52 • n=7 Participants	33.5 Years STANDARD_DEVIATION 12.24 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	85 Participants n=7 Participants	166 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	31 Participants n=7 Participants	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	117 Participants n=5 Participants	116 Participants n=7 Participants	233 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants	8 Participants n=7 Participants	28 Participants n=5 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
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	93 Participants n=5 Participants	102 Participants n=7 Participants	195 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Schiff Sensitivity Score at Baseline	2.12 Score on a scale STANDARD_DEVIATION 0.300 • n=5 Participants	2.12 Score on a scale STANDARD_DEVIATION 0.299 • n=7 Participants	2.12 Score on a scale STANDARD_DEVIATION 0.299 • n=5 Participants
Tactile Sensitivity - Tactile Threshold at Baseline	10.85 grams (g) STANDARD_DEVIATION 2.482 • n=5 Participants	10.69 grams (g) STANDARD_DEVIATION 2.074 • n=7 Participants	10.77 grams (g) STANDARD_DEVIATION 2.285 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 3

Population: Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.

Outcome measures

Outcome measures
Measure	Stannous Fluoride n=117 Participants Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.	Sodium Monofluorophosphate n=116 Participants Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
Change From Baseline in Schiff Sensitivity Score on Day 3	-1.40 Score on a scale Standard Deviation 0.550	-0.38 Score on a scale Standard Deviation 0.501

SECONDARY outcome

Timeframe: Baseline to 60 seconds post first treatment

Outcome measures

Outcome measures
Measure	Stannous Fluoride n=117 Participants Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.	Sodium Monofluorophosphate n=116 Participants Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application	-0.89 Score on a Scale Standard Deviation 0.533	-0.17 Score on a Scale Standard Deviation 0.329

SECONDARY outcome

Timeframe: Baseline to 60 seconds post first treatment

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.

Outcome measures

Outcome measures
Measure	Stannous Fluoride n=117 Participants Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.	Sodium Monofluorophosphate n=116 Participants Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
Change From Baseline in Tactile Threshold Post First Treatment by Direct Application	19.49 g Standard Deviation 16.392	3.66 g Standard Deviation 6.704

SECONDARY outcome

Timeframe: Baseline to Day 3

Outcome measures

Outcome measures
Measure	Stannous Fluoride n=117 Participants Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.	Sodium Monofluorophosphate n=116 Participants Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
Change From Baseline in Tactile Threshold on Day 3	35.47 g Standard Deviation 21.131	6.55 g Standard Deviation 11.002

Adverse Events

Stannous Fluoride

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Sodium Monofluorophosphate

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stannous Fluoride n=117 participants at risk Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.	Sodium Monofluorophosphate n=116 participants at risk Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.85% 1/117	0.00% 0/116

Other adverse events

Other adverse events
Measure	Stannous Fluoride n=117 participants at risk Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.	Sodium Monofluorophosphate n=116 participants at risk Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
Musculoskeletal and connective tissue disorders BACK PAIN	0.85% 1/117 • Number of events 1	0.00% 0/116
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/117	0.86% 1/116 • Number of events 1
Nervous system disorders HEADACHE	0.00% 0/117	1.7% 2/116 • Number of events 2

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