Trial Outcomes & Findings for To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH) (NCT NCT02923895)

Last Updated: 2018-10-29

Results Overview

The examiner assessed the participant's response to an evaporative air stimulus for each of the two test tooth using the Schiff Sensitivity Scale which was scored as follows: 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 requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. The Schiff sensitivity score was calculated as the average of individual test teeth score. Change from baseline in Schiff sensitivity was calculated as participant level mean change from baseline of the 2 test teeth. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

197 participants

Primary outcome timeframe

Baseline and Day 3

Results posted on

2018-10-29

Participant Flow

Participants were recruited at a single clinical site in Canada.

A total of 197 participants were screened and enrolled in the study, out of which 192 participants were randomized to the study treatments. Five participants were not randomized: 1 participant was screening failure, and 4 participants withdrew their consent.

Participant milestones

Participant milestones
Measure	Test Dentifrice Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily.	Control Dentifrice Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants brushed the whole mouth thoroughly for at least 1 minute twice daily.
Overall Study STARTED	97	95
Overall Study COMPLETED	97	95
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Dentifrice n=97 Participants Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily.	Control Dentifrice n=95 Participants Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants brushed the whole mouth thoroughly for at least 1 minute twice daily.	Total n=192 Participants Total of all reporting groups
Age, Continuous	46.8 Years STANDARD_DEVIATION 12.95 • n=5 Participants	46.9 Years STANDARD_DEVIATION 10.53 • n=7 Participants	46.9 Years STANDARD_DEVIATION 11.79 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	72 Participants n=7 Participants	140 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	23 Participants n=7 Participants	52 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	16 Participants n=5 Participants	12 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	18 Participants n=5 Participants	31 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants	51 Participants n=7 Participants	113 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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

PRIMARY outcome

Timeframe: Baseline and 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	Test Dentifrice n=97 Participants Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily.	Control Dentifrice n=95 Participants Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants brushed the whole mouth thoroughly for at least 1 minute twice daily.
Change From Baseline in Schiff Sensitivity Score on Day 3 At Baseline (Day 0, Pre-treatment)	2.44 Score on a scale Standard Deviation 0.450	2.49 Score on a scale Standard Deviation 0.475
Change From Baseline in Schiff Sensitivity Score on Day 3 At Day 3	1.01 Score on a scale Standard Deviation 0.956	2.37 Score on a scale Standard Deviation 0.571
Change From Baseline in Schiff Sensitivity Score on Day 3 Change from Baseline	-1.44 Score on a scale Standard Deviation 0.811	-0.13 Score on a scale Standard Deviation 0.431

SECONDARY outcome

Timeframe: Baseline and 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.

Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 gram\[g\] to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave 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	Test Dentifrice n=97 Participants Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily.	Control Dentifrice n=95 Participants Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants brushed the whole mouth thoroughly for at least 1 minute twice daily.
Change From Baseline in Tactile Threshold on Day 3 At Baseline	13.40 g Standard Deviation 4.242	13.58 g Standard Deviation 4.416
Change From Baseline in Tactile Threshold on Day 3 At Day 3	39.28 g Standard Deviation 20.979	14.89 g Standard Deviation 6.357
Change From Baseline in Tactile Threshold on Day 3 Change from Baseline	25.88 g Standard Deviation 19.804	1.32 g Standard Deviation 6.111

SECONDARY outcome

Timeframe: Baseline to 60 seconds post first treatment

Outcome measures

Outcome measures
Measure	Test Dentifrice n=97 Participants Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily.	Control Dentifrice n=95 Participants Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants brushed the whole mouth thoroughly for at least 1 minute twice daily.
Change From Baseline in Schiff Sensitivity Score After a Single Use At Baseline (Day 0, Pre-treatment)	2.44 Score on a scale Standard Deviation 0.450	2.49 Score on a scale Standard Deviation 0.475
Change From Baseline in Schiff Sensitivity Score After a Single Use Day 0 (Post-treatment)	1.76 Score on a scale Standard Deviation 0.781	2.40 Score on a scale Standard Deviation 0.534
Change From Baseline in Schiff Sensitivity Score After a Single Use Change from Baseline	-0.68 Score on a scale Standard Deviation 0.704	-0.09 Score on a scale Standard Deviation 0.401

SECONDARY outcome

Timeframe: Baseline to 60 seconds post first treatment

Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave 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	Test Dentifrice n=97 Participants Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily.	Control Dentifrice n=95 Participants Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants brushed the whole mouth thoroughly for at least 1 minute twice daily.
Change From Baseline in Tactile Threshold After a Single Use Day 0, Post-treatment	22.47 g Standard Deviation 11.839	14.63 g Standard Deviation 6.069
Change From Baseline in Tactile Threshold After a Single Use Change from Baseline	9.07 g Standard Deviation 11.418	1.05 g Standard Deviation 5.644
Change From Baseline in Tactile Threshold After a Single Use At Baseline (Day 0, Pre-treatment)	13.40 g Standard Deviation 4.242	13.58 g Standard Deviation 4.416

Adverse Events

Test Dentifrice

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control 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

Other adverse events
Measure	Test Dentifrice n=97 participants at risk Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then first brushed each of the qualifying test teeth for 30 seconds each followed by the whole mouth thoroughly for at least 1 timed minute twice daily.	Control Dentifrice n=95 participants at risk Participants were instructed to dose a dry toothbrush with a full strip of toothpaste. Participants then brushed the whole mouth thoroughly for at least 1 minute twice daily.
Nervous system disorders Headache	1.0% 1/97 • Approximately 64 days (from Screening Visit to till 5 days following last administration of study product on Visit 3)	0.00% 0/95 • Approximately 64 days (from Screening Visit to till 5 days following last administration of study product on Visit 3)

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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