Trial Outcomes & Findings for Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (NCT NCT02731833)

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

PHASE4

Target enrollment

229 participants

Primary outcome timeframe

Baseline to Day 3

Results posted on

2017-05-17

Participant Flow

Participants were recruited at single clinical site in Canada.

A total of 229 participants were screened. Out of which 222 participants were randomized. 7 participants were not randomized because these participants did not meet study criteria.

Participant milestones

Participant milestones
Measure	Stannous Fluoride Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million \[ppm\] fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Sodium Monofluorophosphate Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Overall Study STARTED	111	111
Overall Study COMPLETED	111	111
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stannous Fluoride n=111 Participants Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Sodium Monofluorophosphate n=111 Participants Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Total n=222 Participants Total of all reporting groups
Age, Continuous	46.4 Years STANDARD_DEVIATION 10.77 • n=5 Participants	47.6 Years STANDARD_DEVIATION 10.95 • n=7 Participants	47.0 Years STANDARD_DEVIATION 10.85 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	81 Participants n=7 Participants	163 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	109 Participants n=5 Participants	110 Participants n=7 Participants	219 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	18 Participants n=5 Participants	15 Participants n=7 Participants	33 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	33 Participants n=5 Participants	23 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants	73 Participants n=7 Participants	133 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	2.50 Score on a Scale STANDARD_DEVIATION 0.484 • n=5 Participants	2.46 Score on a Scale STANDARD_DEVIATION 0.461 • n=7 Participants	2.48 Score on a Scale STANDARD_DEVIATION 0.472 • n=5 Participants
Tactile Sensitivity - Tactile Threshold at Baseline	12.66 gram (g) STANDARD_DEVIATION 4.201 • n=5 Participants	13.42 gram (g) STANDARD_DEVIATION 4.263 • n=7 Participants	13.04 gram (g) STANDARD_DEVIATION 4.240 • 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=111 Participants Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Sodium Monofluorophosphate n=111 Participants Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Change From Baseline in Schiff Sensitivity Score on Day 3	-0.40 Score on a scale Standard Deviation 0.485	0.00 Score on a scale Standard Deviation 0.257

SECONDARY outcome

Timeframe: Baseline to Day 3

Population: Analysis for this outcome was performed on 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.

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.

Outcome measures

Outcome measures
Measure	Stannous Fluoride n=111 Participants Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Sodium Monofluorophosphate n=111 Participants Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Change From Baseline in Tactile Threshold on Day 3	3.69 g Standard Deviation 4.941	0.09 g Standard Deviation 2.521

SECONDARY outcome

Timeframe: Baseline to 60 seconds post first treatment

Outcome measures

Outcome measures
Measure	Stannous Fluoride n=111 Participants Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Sodium Monofluorophosphate n=111 Participants Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application	-0.17 Score on a scale Standard Deviation 0.340	-0.02 Score on a scale Standard Deviation 0.269

SECONDARY outcome

Timeframe: Baseline to 60 seconds post first treatment

Outcome measures

Outcome measures
Measure	Stannous Fluoride n=111 Participants Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Sodium Monofluorophosphate n=111 Participants Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Change From Baseline in Tactile Threshold Post First Treatment by Direct Application	1.71 g Standard Deviation 3.268	0.18 g Standard Deviation 2.328

Adverse Events

Stannous Fluoride

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sodium Monofluorophosphate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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