Trial Outcomes & Findings for The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (NCT NCT02612064)

NCT ID: NCT02612064

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

488 participants

Primary outcome timeframe

Baseline to 3 days

Results posted on

2017-05-17

Participant Flow

Participants were recruited at the clinical site in United Kingdom (UK).

In total, 488 participants were screened, out of which 230 participants were randomized.

Participant milestones

Participant milestones
Measure	Stannous Fluoride Test: 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. For at home use, 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. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
Overall Study STARTED	115	115
Overall Study COMPLETED	114	112
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Stannous Fluoride Test: 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. For at home use, 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. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
Overall Study Withdrawal by Subject	1	1
Overall Study Other	0	2

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stannous Fluoride n=115 Participants Test: 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. For at home use, 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=115 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. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.	Total n=230 Participants Total of all reporting groups
Age, Continuous	40.7 Years STANDARD_DEVIATION 8.62 • n=99 Participants	39.9 Years STANDARD_DEVIATION 9.18 • n=107 Participants	40.3 Years STANDARD_DEVIATION 8.89 • n=206 Participants
Sex: Female, Male Female	91 Participants n=99 Participants	92 Participants n=107 Participants	183 Participants n=206 Participants
Sex: Female, Male Male	24 Participants n=99 Participants	23 Participants n=107 Participants	47 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	115 Participants n=99 Participants	115 Participants n=107 Participants	230 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) White	112 Participants n=99 Participants	112 Participants n=107 Participants	224 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Schiff Sensitivity Score at Baseline	2.82 score on a scale STANDARD_DEVIATION 0.333 • n=99 Participants • 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.	2.80 score on a scale STANDARD_DEVIATION 0.330 • n=107 Participants • 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.	2.81 score on a scale STANDARD_DEVIATION 0.331 • n=206 Participants • 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.
Tactile Sensitivity - Tactile Threshold at Baseline	12.26 gram (g) STANDARD_DEVIATION 2.905 • n=99 Participants • 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.	12.52 gram (g) STANDARD_DEVIATION 3.202 • n=107 Participants • 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.	12.39 gram (g) STANDARD_DEVIATION 3.053 • n=206 Participants • 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.

PRIMARY outcome

Timeframe: Baseline to 3 days

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.

Outcome measures

Outcome measures
Measure	Stannous Fluoride n=115 Participants Test: 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. For at home use, 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=115 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. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
Change From Baseline in Schiff Sensitivity Score on Day 3	-0.96 Score on a scale Standard Deviation 1.003	-0.77 Score on a scale Standard Deviation 0.947

SECONDARY outcome

Timeframe: Baseline to 60 seconds post first treatment

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.

Outcome measures

Outcome measures
Measure	Stannous Fluoride n=115 Participants Test: 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. For at home use, 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=115 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. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application	-0.41 score on a scale Standard Deviation 0.760	-0.31 score on a scale Standard Deviation 0.690

SECONDARY outcome

Timeframe: Baseline, 60 seconds post first treatment, Day 3

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=115 Participants Test: 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. For at home use, 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=115 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. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3 Change from Baseline to Day 3	15.09 g Standard Deviation 20.642	12.77 g Standard Deviation 19.543
Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3 Change from Baseline to Day 0, Post-Treatment	8.83 g Standard Deviation 16.254	4.74 g Standard Deviation 9.975

Adverse Events

Stannous Fluoride

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Sodium Monofluorophosphate

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Stannous Fluoride n=115 participants at risk Test: 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. For at home use, 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=115 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. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
Gastrointestinal disorders Chapped Lips	0.87% 1/115 • Number of events 1	0.00% 0/115
Gastrointestinal disorders Glossodynia	0.87% 1/115 • Number of events 1	0.00% 0/115
Gastrointestinal disorders Mouth Ulceration	0.00% 0/115	0.87% 1/115 • Number of events 1
Injury, poisoning and procedural complications Mouth Injury	0.87% 1/115 • Number of events 1	0.00% 0/115
Nervous system disorders Headache	0.87% 1/115 • Number of events 1	0.87% 1/115 • Number of events 1
Nervous system disorders Migraine	0.00% 0/115	0.87% 1/115 • Number of events 1
Infections and infestations Rhinitis	0.00% 0/115	0.87% 1/115 • Number of events 1
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/115	0.87% 1/115 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/115	0.87% 1/115 • Number of events 1

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