Trial Outcomes & Findings for The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH) (NCT NCT02924350)

Last Updated: 2018-08-20

Results Overview

The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale 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. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.

Recruitment status

COMPLETED

Study phase

Target enrollment

205 participants

Primary outcome timeframe

Baseline, Day 3

Results posted on

2018-08-20

Participant Flow

Participants were recruited at one center in the United Kingdom.

A total of 246 participants were screened, out of which 205 participants enrolled in the study. 41 of screened participants were not enrolled because of screening failure. Of 205 enrolled participants, 204 were randomized in study, one participant was not randomized due to lost to follow up.

Participant milestones

Participant milestones
Measure	Test Dentifrice Containing Stannous Fluoride All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).	Control Dentifrice Containing Sodium Monofluorophosphate All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
Overall Study STARTED	102	102
Overall Study COMPLETED	102	100
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Dentifrice Containing Stannous Fluoride n=102 Participants All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).	Control Dentifrice Containing Sodium Monofluorophosphate n=102 Participants All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).	Total n=204 Participants Total of all reporting groups
Age, Continuous	22.8 years STANDARD_DEVIATION 6.61 • n=5 Participants	22.2 years STANDARD_DEVIATION 5.12 • n=7 Participants	22.5 years STANDARD_DEVIATION 5.91 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	74 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	28 Participants n=7 Participants	65 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	11 Participants n=5 Participants	5 Participants n=7 Participants	16 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	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants	90 Participants n=7 Participants	175 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	4 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 3

Population: 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. Number of participants analyzed is from ITT population evaluated at specific time points for each treatment arms respectively.

Outcome measures

Outcome measures
Measure	Test Dentifrice Containing Stannous Fluoride n=102 Participants All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).	Control Dentifrice Containing Sodium Monofluorophosphate n=100 Participants All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
Change From Baseline in Schiff Sensitivity Score on Day 3	-1.37 score on a scale Standard Deviation 0.520	-0.45 score on a scale Standard Deviation 0.443

SECONDARY outcome

Timeframe: At Baseline (Day 0 pre-treatment) and after 60 seconds of single direct application on Day 0

Population: 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 the ITT population evaluated at specific time points for each treatment arms respectively.

Outcome measures

Outcome measures
Measure	Test Dentifrice Containing Stannous Fluoride n=102 Participants All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).	Control Dentifrice Containing Sodium Monofluorophosphate n=102 Participants All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
Change From Baseline (Day 0 Pre-treatment) in Schiff Sensitivity Score on Day 0 (After 60 Seconds of Single Direct Application)	-0.63 score on a scale Standard Deviation 0.536	-0.38 score on a scale Standard Deviation 0.413

SECONDARY outcome

Timeframe: At Baseline (Day 0 pre-treatment), after 60 seconds of single direct application on Day 0 and Day 3

Population: 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 from ITT population evaluated at specific time points for each treatment arms respectively.

The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10gram (g) and raised 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 gave two consecutive 'yes' responses were recorded as the tactile threshold. Higher tactile threshold means less sensitive tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.

Outcome measures

Outcome measures
Measure	Test Dentifrice Containing Stannous Fluoride n=102 Participants All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).	Control Dentifrice Containing Sodium Monofluorophosphate n=102 Participants All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
Change From Baseline (Day 0 Pre-treatment) in Tactile Threshold on Day 0 (After 60 Seconds of Single Direct Application) and Day 3 Change from baseline on Day 3	32.79 g Standard Deviation 17.257	10.45 g Standard Deviation 11.149
Change From Baseline (Day 0 Pre-treatment) in Tactile Threshold on Day 0 (After 60 Seconds of Single Direct Application) and Day 3 Change from baseline on Day 0	15.10 g Standard Deviation 14.229	8.14 g Standard Deviation 9.823

Adverse Events

Test Dentifrice Containing Stannous Fluoride

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Control Dentifrice Containing Sodium Monofluorophosphate

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Test Dentifrice Containing Stannous Fluoride n=102 participants at risk All the participants in the test arm applied test dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using test dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).	Control Dentifrice Containing Sodium Monofluorophosphate n=102 participants at risk All the participants in the control arm applied control dentifrice on their two test teeth using their finger, followed by brushing these test teeth, followed by brushing the whole mouth using control dentifrice. Participants brushed their teeth for 3 days twice daily (morning /evening).
Nervous system disorders Headache	2.0% 2/102 • Number of events 2 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.	5.9% 6/102 • Number of events 6 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.
Nervous system disorders Dizzines	0.98% 1/102 • Number of events 1 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.	0.00% 0/102 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.
Nervous system disorders Migraine	0.98% 1/102 • Number of events 1 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.	0.00% 0/102 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.
Ear and labyrinth disorders Ear Pain	0.98% 1/102 • Number of events 1 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.	0.00% 0/102 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.
Gastrointestinal disorders Toothache	0.98% 1/102 • Number of events 1 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.	0.00% 0/102 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/102 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.	0.98% 1/102 • Number of events 1 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.
Gastrointestinal disorders Dyspepsia	0.00% 0/102 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.	0.98% 1/102 • Number of events 1 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.
Immune system disorders Seasonal Allergy	0.98% 1/102 • Number of events 1 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.	0.00% 0/102 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.
Musculoskeletal and connective tissue disorders Pain in extremity	0.98% 1/102 • Number of events 1 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.	0.00% 0/102 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/102 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.	0.98% 1/102 • Number of events 1 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.
Reproductive system and breast disorders Dysmenorrhoea	0.98% 1/102 • Number of events 1 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.	0.00% 0/102 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.
Infections and infestations Nasopharyngitis	0.00% 0/102 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.	2.0% 2/102 • Number of events 2 • up to 64 days (from completion of the first use of acclimatisation dentifrice until 5 days following last administration of study product on Visit 3) The time frame for adverse event (AE) reporting was calculated as 64 days including maximum (max.) 56 days of acclimatization period (minimum 28 days and max of 56 days of regular fluoride dentifrice use in acclimatization period, in between of screening and baseline visit), followed by 3 study days and 5 follow up days.

Additional Information

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