Trial Outcomes & Findings for The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity (NCT NCT01592864)

Results Overview

Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

Baseline to 8 weeks post administration of study treatment

Results posted on

2014-03-10

Participant Flow

Participants were recruited at the clinical site.

Of 122 participants screened, 2 participants did not meet the study criteria, and 2 withdrew consent before randomization. 118 participants were randomized to study treatments.

Participant milestones

Participant milestones
Measure	Stannous Fluoride (SnF) Dentifrice Participants brushed whole mouth with 1-inch strip of the test dentifrice 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 milliliter (mL) of water.	Sodium Monofluorophosphate (NaMFP) Dentifrice Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
Overall Study STARTED	60	58
Overall Study COMPLETED	60	57
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Stannous Fluoride (SnF) Dentifrice Participants brushed whole mouth with 1-inch strip of the test dentifrice 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 milliliter (mL) of water.	Sodium Monofluorophosphate (NaMFP) Dentifrice Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SnF Dentifrice n=60 Participants Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.	NaMFP Dentifrice n=58 Participants Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.	Total n=118 Participants Total of all reporting groups
Age, Continuous	36.9 Years STANDARD_DEVIATION 10.9 • n=93 Participants	35.5 Years STANDARD_DEVIATION 10.6 • n=4 Participants	36.2 Years STANDARD_DEVIATION 10.7 • n=27 Participants
Sex: Female, Male Female	46 Participants n=93 Participants	37 Participants n=4 Participants	83 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	21 Participants n=4 Participants	35 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to 8 weeks post administration of study treatment

Population: Intent to Treat (ITT) Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.

Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.

Outcome measures

Outcome measures
Measure	SnF Dentifrice n=60 Participants Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.	NaMFP Dentifrice n=58 Participants Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8	-0.9 Score on a scale Standard Deviation 0.68	-0.5 Score on a scale Standard Deviation 0.44

SECONDARY outcome

Timeframe: Baseline to 4 weeks post administration of study treatment

Population: ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.

Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.

Outcome measures

Outcome measures
Measure	SnF Dentifrice n=60 Participants Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.	NaMFP Dentifrice n=58 Participants Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4	-0.7 Score on a scale Standard Deviation 0.58	-0.2 Score on a scale Standard Deviation 0.43

SECONDARY outcome

Timeframe: Baseline to 8 weeks post administration of study treatment

Population: ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.

Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated. sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached.

Outcome measures

Outcome measures
Measure	SnF Dentifrice n=60 Participants Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.	NaMFP Dentifrice n=58 Participants Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8	21.3 grams Standard Deviation 21.80	4.2 grams Standard Deviation 6.18

SECONDARY outcome

Timeframe: Baseline to 4 weeks post administration of study treatment

Population: ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.

Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated

Outcome measures

Outcome measures
Measure	SnF Dentifrice n=60 Participants Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.	NaMFP Dentifrice n=58 Participants Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4	11.2 grams Standard Deviation 15.95	1.5 grams Standard Deviation 3.86

Adverse Events

SnF Dentifrice

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

NaMFP Dentifrice

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SnF Dentifrice n=60 participants at risk Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.	NaMFP Dentifrice n=58 participants at risk Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
Hepatobiliary disorders Cholecystitis	0.00% 0/60 • All adverse events encountered or spontaneously reported following administration of any investigational product, or for up to 5 days after the last administration of investigational product were recorded.	1.7% 1/58 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product, or for up to 5 days after the last administration of investigational product were recorded.

Other adverse events

Other adverse events
Measure	SnF Dentifrice n=60 participants at risk Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.	NaMFP Dentifrice n=58 participants at risk Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
Infections and infestations Oral Herpes	1.7% 1/60 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product, or for up to 5 days after the last administration of investigational product were recorded.	0.00% 0/58 • All adverse events encountered or spontaneously reported following administration of any investigational product, or for up to 5 days after the last administration of investigational product were recorded.

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