Trial Outcomes & Findings for Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity (NCT NCT01592851)

NCT ID: NCT01592851

Last Updated: 2014-06-03

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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 113 participants
• Primary outcome timeframe: Baseline to Day 14
• Results posted on: 2014-06-03

Participant Flow

Participants were recruited at the clinical site.

Of 126 participants screened, 9 participants did not meet the study criteria, 3 were lost to follow up and 1 withdrew consent before randomization. Remaining 113 participants were randomized to study treatments.

Participant milestones

Measure	Stannous Fluoride (SnF) Dentifrice Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.	Sodium Monofluorophosphate (NaMFP) Dentifrice Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% Sodium Monofluorophosphate \[NaMFP\]) for one timed minute, followed by rinsing with 5 mL of water.
Overall Study STARTED	56	57
Overall Study COMPLETED	56	57
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity

Baseline characteristics by cohort

Measure	SnF Dentifrice n=56 Participants Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.	NaMFP Dentifrice n=57 Participants Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.	Total n=113 Participants Total of all reporting groups
Age, Continuous	38.1 Years STANDARD_DEVIATION 10.70 • n=93 Participants	34.8 Years STANDARD_DEVIATION 9.86 • n=4 Participants	36.5 Years STANDARD_DEVIATION 10.37 • n=27 Participants
Sex: Female, Male Female	37 Participants n=93 Participants	42 Participants n=4 Participants	79 Participants n=27 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	15 Participants n=4 Participants	34 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline to Day 14

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.

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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.

Outcome measures

Measure	SnF Dentifrice n=56 Participants Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.	NaMFP Dentifrice n=57 Participants Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14	-1.20 Score on a scale Standard Deviation 0.70	-0.37 Score on a scale Standard Deviation 0.43

SECONDARY outcome

Timeframe: Baseline to immediately post treatment administration

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.

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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.

Outcome measures

Measure	SnF Dentifrice n=56 Participants Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.	NaMFP Dentifrice n=57 Participants Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment	-0.40 Score on a scale Standard Deviation 0.46	-0.14 Score on a scale Standard Deviation 0.35

SECONDARY outcome

Timeframe: Baseline to Day 3

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.

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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.

Outcome measures

Measure	SnF Dentifrice n=56 Participants Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.	NaMFP Dentifrice n=57 Participants Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3	-0.70 Score on a scale Standard Deviation 0.60	-0.25 Score on a scale Standard Deviation 0.39

SECONDARY outcome

Timeframe: Baseline to Day 14

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.

The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity

Outcome measures

Measure	SnF Dentifrice n=56 Participants Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.	NaMFP Dentifrice n=57 Participants Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
Change From Baseline in Tactile Pain Threshold Score at Day 14	22.9 Force (grams) Standard Deviation 21.14	3.5 Force (grams) Standard Deviation 5.67

SECONDARY outcome

Timeframe: Baseline to Day 3

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.

The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.

Outcome measures

Measure	SnF Dentifrice n=56 Participants Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.	NaMFP Dentifrice n=57 Participants Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
Change From Baseline in Tactile Pain Threshold Score at Day 3	9.8 Force (grams) Standard Deviation 15.52	3.0 Force (grams) Standard Deviation 4.90

SECONDARY outcome

Timeframe: Baseline to immediately post treatment administration

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.

The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.

Outcome measures

Measure	SnF Dentifrice n=56 Participants Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.	NaMFP Dentifrice n=57 Participants Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment	5.8 Force (grams) Standard Deviation 10.17	1.9 Force (grams) Standard Deviation 3.24

Adverse Events

SnF Dentifrice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NaMFP Dentifrice

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