Trial Outcomes & Findings for The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity (NCT NCT03072719)

Last Updated: 2018-03-06

Results Overview

Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

Baseline, Day 14

Results posted on

2018-03-06

Participant Flow

Participants were recruited at a single center in Ireland.

Total 394 participants were screened, out of which 120 participants were randomized. 274 participants were not randomized because 248 participants did not meet the study criteria, 4 participants were lost to follow up, and 7 participants withdrew the consent and 15 participants for other reasons (not-specified).

Participant milestones

Participant milestones
Measure	Experimental Dentifrice Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100 parts per million \[ppm\] as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.	Reference Dentifrice Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute.
Overall Study STARTED	60	60
Overall Study COMPLETED	59	59
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Dentifrice Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100 parts per million \[ppm\] as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.	Reference Dentifrice Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute.
Overall Study Adverse Event	1	1

Baseline Characteristics

The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Dentifrice n=60 Participants Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.	Reference Dentifrice n=60 Participants Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute.	Total n=120 Participants Total of all reporting groups
Age, Continuous	28.4 Years STANDARD_DEVIATION 12.85 • n=5 Participants	30.7 Years STANDARD_DEVIATION 11.66 • n=7 Participants	29.5 Years STANDARD_DEVIATION 12.27 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	40 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=5 Participants	59 Participants n=7 Participants	118 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants	59 Participants n=7 Participants	119 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

PRIMARY outcome

Timeframe: Baseline, Day 14

Population: Analysis for this outcome was conducted on intent-to-treat (ITT) population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time point for treatment arms respectively.

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=60 Participants Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.	Reference Dentifrice n=60 Participants Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute.
Change From Baseline in Schiff Sensitivity Score on Day 14 At Baseline	2.51 score on a scale Standard Deviation 0.437	2.51 score on a scale Standard Deviation 0.446
Change From Baseline in Schiff Sensitivity Score on Day 14 At Day 14	1.16 score on a scale Standard Deviation 0.774	1.35 score on a scale Standard Deviation 0.901
Change From Baseline in Schiff Sensitivity Score on Day 14 Change from Baseline on Day 14	-1.35 score on a scale Standard Deviation 0.727	-1.16 score on a scale Standard Deviation 0.762

SECONDARY outcome

Timeframe: Baseline, post first brushing (after 5 minutes) and Day 3

Population: Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively.

Outcome measures

Outcome measures
Measure	Experimental Dentifrice n=60 Participants Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.	Reference Dentifrice n=60 Participants Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute.
Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 After 5 minutes of brushing	1.73 score on a scale Standard Deviation 0.826	1.92 score on a scale Standard Deviation 0.737
Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 Change after 5 minutes of brushing	-0.78 score on a scale Standard Deviation 0.660	-0.59 score on a scale Standard Deviation 0.571
Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 On Day 3	1.63 score on a scale Standard Deviation 0.784	1.77 score on a scale Standard Deviation 0.785
Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 Change from baseline on Day 3	-0.88 score on a scale Standard Deviation 0.658	-0.74 score on a scale Standard Deviation 0.568

SECONDARY outcome

Timeframe: Baseline, post first brushing (after 5 minutes), Day 3 and Day 14

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	Experimental Dentifrice n=60 Participants Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.	Reference Dentifrice n=60 Participants Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute.
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 Change from baseline on Day 3	7.5 gram (g) Standard Deviation 17.73	7.1 gram (g) Standard Deviation 16.48
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 On Day 3	18.4 gram (g) Standard Deviation 17.32	18.6 gram (g) Standard Deviation 16.73
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 On Day 14	25.3 gram (g) Standard Deviation 22.64	23.8 gram (g) Standard Deviation 22.33
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 At Baseline	10.8 gram (g) Standard Deviation 2.29	11.5 gram (g) Standard Deviation 2.65
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 After 5 minutes of brushing	16.5 gram (g) Standard Deviation 13.82	16.7 gram (g) Standard Deviation 11.19
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 Change after 5 minutes of brushing	5.7 gram (g) Standard Deviation 13.45	5.2 gram (g) Standard Deviation 10.93
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 Change from baseline on Day 14	14.6 gram (g) Standard Deviation 22.67	12.3 gram (g) Standard Deviation 21.68

Adverse Events

Experimental Dentifrice

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Reference Dentifrice

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental Dentifrice n=60 participants at risk Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.	Reference Dentifrice n=60 participants at risk Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer's instructions), for at least 1 minute.
Gastrointestinal disorders Sensitivity of Teeth	8.3% 5/60	0.00% 0/60
Gastrointestinal disorders Dry Mouth	0.00% 0/60	3.3% 2/60
Gastrointestinal disorders Gingival Bleeding	0.00% 0/60	1.7% 1/60
Gastrointestinal disorders Gingivitis	1.7% 1/60	0.00% 0/60
Gastrointestinal disorders Mouth Ulceration	0.00% 0/60	1.7% 1/60
Infections and infestations Oral Herpes	0.00% 0/60	1.7% 1/60
Injury, poisoning and procedural complications Tooth Injury	1.7% 1/60	0.00% 0/60
Gastrointestinal disorders Toothache	1.7% 1/60	0.00% 0/60
Infections and infestations Axillary Candidiasis	1.7% 1/60	0.00% 0/60
General disorders Axillary Pain	1.7% 1/60	0.00% 0/60
Infections and infestations Gastroenteritis Viral	1.7% 1/60	0.00% 0/60
Nervous system disorders Headache	0.00% 0/60	1.7% 1/60
General disorders Influenza Like Illness	0.00% 0/60	1.7% 1/60
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	1.7% 1/60	0.00% 0/60
Infections and infestations Viral Infection	0.00% 0/60	1.7% 1/60

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