Trial Outcomes & Findings for Study Investigating Efficacy of an Occluding Dentifrice for Dentine Hypersensitivity (NCT NCT02705716)

Last Updated: 2017-04-25

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

Target enrollment

409 participants

Primary outcome timeframe

Baseline, Day 14

Results posted on

2017-04-25

Participant Flow

Participants were recruited at one center (2 sites) in United Kingdom.

A total of 409 participants were screened, out of which 142 participants were randomized. 267 participants were not randomized because 183 participants did not met the study criteria, 1 had adverse event, 2 were lost to follow up, 7 had protocol violation, 2 withdrew consent and 72 were not randomized for other reasons (not specified).

Participant milestones

Participant milestones
Measure	Test Dentifrice Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million \[ppm\] fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Control Dentifrice Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Overall Study STARTED	72	70
Overall Study COMPLETED	68	68
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Dentifrice Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million \[ppm\] fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Control Dentifrice Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Overall Study Adverse Event	0	1
Overall Study Protocol Violation	3	0
Overall Study Withdrawal of Consent	1	1

Baseline Characteristics

This baseline measurement was performed on intent to treat (ITT) population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Dentifrice n=70 Participants Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Control Dentifrice n=69 Participants Participants were instructed to apply a full brush head of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Total n=139 Participants Total of all reporting groups
Age, Continuous	39.9 Years STANDARD_DEVIATION 10.72 • n=5 Participants	39.9 Years STANDARD_DEVIATION 9.53 • n=7 Participants	39.9 Years STANDARD_DEVIATION 10.11 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	57 Participants n=7 Participants	110 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=5 Participants	69 Participants n=7 Participants	137 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	3 Participants n=5 Participants	3 Participants n=7 Participants	6 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	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	59 Participants n=7 Participants	116 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	3 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
Schiff Sensitivity Score at Baseline	2.80 score on a scale STANDARD_DEVIATION 0.323 • n=5 Participants • This baseline measurement was performed on intent to treat (ITT) population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.	2.83 score on a scale STANDARD_DEVIATION 0.307 • n=7 Participants • This baseline measurement was performed on intent to treat (ITT) population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.	2.81 score on a scale STANDARD_DEVIATION 0.314 • n=5 Participants • This baseline measurement was performed on intent to treat (ITT) population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.
Tactile Threshold at Baseline	11.50 gram (g) STANDARD_DEVIATION 2.739 • n=5 Participants • This baseline measurement was performed on ITT population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.	12.03 gram (g) STANDARD_DEVIATION 3.010 • n=7 Participants • This baseline measurement was performed on ITT population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.	11.76 gram (g) STANDARD_DEVIATION 2.878 • n=5 Participants • This baseline measurement was performed on ITT population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy.

PRIMARY outcome

Timeframe: Baseline, Day 14

Population: Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 14.

Outcome measures

Outcome measures
Measure	Test Dentifrice n=68 Participants Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Control Dentifrice n=68 Participants Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Change From Baseline in Schiff Sensitivity Score on Day 14	-1.01 score on a scale Standard Deviation 1.093	-0.88 score on a scale Standard Deviation 1.110

SECONDARY outcome

Timeframe: Baseline, Day 7

Outcome measures

Outcome measures
Measure	Test Dentifrice n=70 Participants Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Control Dentifrice n=69 Participants Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Change From Baseline in Schiff Sensitivity Score on Day 7	-0.49 score on a scale Standard Deviation 0.807	-0.54 score on a scale Standard Deviation 0.785

SECONDARY outcome

Timeframe: Baseline, Day 7 and Day 14

Population: Analysis for this outcome was conducted 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 of efficacy. n=number of participants evaluated at specific time points for each treatment arms respectively.

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=70 Participants Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Control Dentifrice n=69 Participants Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Change From Baseline in Tactile Threshold on Day 7 and 14 Change from baseline on Day 7(n=70,69)	11.21 g Standard Deviation 19.531	10.29 g Standard Deviation 17.634
Change From Baseline in Tactile Threshold on Day 7 and 14 Change from baseline on Day 14(n=68,68)	18.24 g Standard Deviation 24.522	18.90 g Standard Deviation 23.081

Adverse Events

Test Dentifrice

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Control Dentifrice

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Test Dentifrice n=72 participants at risk Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Control Dentifrice n=70 participants at risk Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Gastrointestinal disorders Food Poisoning	1.4% 1/72	0.00% 0/70
Gastrointestinal disorders Gingival Discomfort	1.4% 1/72	0.00% 0/70
Gastrointestinal disorders Nausea	1.4% 1/72	0.00% 0/70
Gastrointestinal disorders Noninfective Gingivitis	1.4% 1/72	0.00% 0/70
Gastrointestinal disorders Oral Mucosal Exfoliation	1.4% 1/72	0.00% 0/70
Gastrointestinal disorders Toothache	1.4% 1/72	0.00% 0/70
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/72	1.4% 1/70
Injury, poisoning and procedural complications Ligament Sprain	2.8% 2/72	0.00% 0/70
Injury, poisoning and procedural complications Traumatic Ulcer	2.8% 2/72	1.4% 1/70
Injury, poisoning and procedural complications Procedural Pain	1.4% 1/72	0.00% 0/70
Injury, poisoning and procedural complications Tooth Fracture	1.4% 1/72	0.00% 0/70
Infections and infestations Conjunctivitis	1.4% 1/72	2.9% 2/70
Infections and infestations Gastroenteritis	1.4% 1/72	0.00% 0/70
Infections and infestations Oral Herpes	1.4% 1/72	1.4% 1/70
Infections and infestations Rhinitis	1.4% 1/72	1.4% 1/70
Infections and infestations Sepsis	1.4% 1/72	0.00% 0/70
Infections and infestations Root Canal Infection	0.00% 0/72	1.4% 1/70
Product Issues Device Failure	1.4% 1/72	0.00% 0/70
Reproductive system and breast disorders Dysmenorrhoea	1.4% 1/72	0.00% 0/70
Nervous system disorders Headache	0.00% 0/72	1.4% 1/70
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/72	1.4% 1/70
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/72	1.4% 1/70
Skin and subcutaneous tissue disorders Rash Generalised	0.00% 0/72	1.4% 1/70

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