Trial Outcomes & Findings for Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (NCT NCT02832375)

Last Updated: 2017-05-25

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

PHASE3

Target enrollment

242 participants

Primary outcome timeframe

Baseline, Day 3

Results posted on

2017-05-25

Participant Flow

Participants were recruited at one center in United States.

A total of 266 participants were screened, out of which 242 participants were randomized. 24 participants were not randomized because 14 participants did not met the study criteria, 1 participant was lost to follow up and 9 participants withdrew consent from the study.

Participant milestones

Participant milestones
Measure	Experimental: Stannous Fluoride(SnF) Participants were instructed to dose a dry toothbrush containing 0.454% weight by weight (w/w) of SnF (1100 parts per million \[ppm\] fluoride) with a full strip (1 inch) of toothpaste. 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: Sodium Monofluorophosphate(SMFP) Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Overall Study STARTED	121	121
Overall Study COMPLETED	119	121
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental: Stannous Fluoride(SnF) Participants were instructed to dose a dry toothbrush containing 0.454% weight by weight (w/w) of SnF (1100 parts per million \[ppm\] fluoride) with a full strip (1 inch) of toothpaste. 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: Sodium Monofluorophosphate(SMFP) Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal of Consent	1	0

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	Experimental: Stannous Fluoride(SnF) n=121 Participants Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. 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: Sodium Monofluorophosphate(SMFP) n=121 Participants Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.	Total n=242 Participants Total of all reporting groups
Age, Continuous	38.0 Years STANDARD_DEVIATION 11.32 • n=5 Participants	37.4 Years STANDARD_DEVIATION 11.01 • n=7 Participants	37.7 Years STANDARD_DEVIATION 11.15 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	78 Participants n=7 Participants	154 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	43 Participants n=7 Participants	88 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	19 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	94 Participants n=5 Participants	102 Participants n=7 Participants	196 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) White	74 Participants n=5 Participants	72 Participants n=7 Participants	146 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	8 Participants n=7 Participants	16 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
Shiff Sensitivity Score at Baseline	2.53 score on a scale STANDARD_DEVIATION 0.389 • 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.	2.55 score on a scale STANDARD_DEVIATION 0.397 • 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.	2.54 score on a scale STANDARD_DEVIATION 0.392 • 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	10.00 gram (g) STANDARD_DEVIATION 0.000 • 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.	10.00 gram (g) STANDARD_DEVIATION 0.000 • 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.	10.00 gram (g) STANDARD_DEVIATION 0.000 • 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 3

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 3.

Outcome measures

Outcome measures
Measure	Experimental: Stannous Fluoride(SnF) n=119 Participants Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. 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: Sodium Monofluorophosphate(SMFP) n=121 Participants Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their 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 3	-0.82 score on a scale Standard Deviation 0.644	-0.39 score on a scale Standard Deviation 0.426

SECONDARY outcome

Timeframe: Baseline, after single use (after 5 minutes)

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. Number of participants analyzed is the ITT Population evaluated post treatment single usage for each treatment arms.

Outcome measures

Outcome measures
Measure	Experimental: Stannous Fluoride(SnF) n=121 Participants Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. 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: Sodium Monofluorophosphate(SMFP) n=121 Participants Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their 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 After Single Use	-0.46 score on a scale Standard Deviation 0.507	-0.45 score on a scale Standard Deviation 0.465

SECONDARY outcome

Timeframe: Baseline, after single use (after 5 minutes) and on Day 3

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	Experimental: Stannous Fluoride(SnF) n=121 Participants Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. 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: Sodium Monofluorophosphate(SMFP) n=121 Participants Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Change From Baseline in Tactile Threshold Immediately After Single Use and on Day 3 Change from baseline post treatment	4.01 g Standard Deviation 7.545	3.60 g Standard Deviation 7.252
Change From Baseline in Tactile Threshold Immediately After Single Use and on Day 3 Change from baseline on Day 3	15.25 g Standard Deviation 17.766	3.88 g Standard Deviation 6.785

Adverse Events

Experimental: Stannous Fluoride(SnF)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard: Sodium Monofluorophosphate(SMFP)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental: Stannous Fluoride(SnF) n=121 participants at risk Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. 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.	Standard: Sodium Monofluorophosphate(SMFP) n=121 participants at risk Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
Gastrointestinal disorders Oral Mucosal Exfoliation	0.83% 1/121	0.00% 0/121
Gastrointestinal disorders Leukoplakia Oral	0.00% 0/121	0.83% 1/121
Gastrointestinal disorders Lip Ulceration	0.00% 0/121	0.83% 1/121

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