Dentine Hypersensitivity
Conditions
Brief summary
A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.
Interventions
DRUGStannous Fluoride
Test dentifrice, participants will brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute.
Control dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion * Demonstrates understanding of the study and willingness to participate * Aged at least 18 to 65 years * Understands and is willing, able and likely to comply with all study procedures and restrictions * Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination. * Self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years * Minimum of 20 natural teeth at screening, a minimum of two accessible teeth (incisors, canines, pre-molars) * At baseline, participant has two non-adjacent sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity measured by tactile stimulus (Yeaple ≤ 20g) and evaporative (air) assessment (Schiff Sensitivity Score ≥ 2) at baseline Exclusion * Pregnant or breast-feeding women * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit * Recent history (within the last year) of alcohol or other substance abuse * An employee of the sponsor or the study site or members of their immediate family * Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes. * Any condition which, in the opinion of the investigator, causes xerostomia * Dental prophylaxis within 4 weeks of screening * Tongue or lip piercing or presence of dental implants * Professional desensitising treatment within 12 weeks of screening * Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening. * Teeth bleaching within 12 weeks of screening * Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening * Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine * Sensitive tooth not expected to respond to treatment with an over-the counter dentifrice in the opinion of the investigator. * Use of a desensitising dentifrice within six weeks of screening (participant will be required to bring their current dentifrice to the site in order to verify the lack of known anti-sensitivity ingredients) * Daily doses of a medication which, in the opinion of the investigator, could interfere with the perception of pain * Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline. * Daily doses of a medication which, in the opinion of the investigator, causes xerostomia * Individuals who require antibiotic prophylaxis for dental procedures * Any participant who, in the judgment of the investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score on Day 14 | Baseline, Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | Baseline, post first brushing (after 5 minutes) and Day 3 | 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 indicate improvement in sensitivity. |
| Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 | 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. |
Countries
Ireland
Participant flow
Recruitment details
Participants were recruited at a single center in Ireland.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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, 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. | 60 |
| 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. | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
Baseline characteristics
| Characteristic | Reference Dentifrice | Total | Experimental Dentifrice |
|---|---|---|---|
| Age, Continuous | 30.7 Years STANDARD_DEVIATION 11.66 | 29.5 Years STANDARD_DEVIATION 12.27 | 28.4 Years STANDARD_DEVIATION 12.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 118 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 59 Participants | 119 Participants | 60 Participants |
| Sex: Female, Male Female | 40 Participants | 75 Participants | 35 Participants |
| Sex: Female, Male Male | 20 Participants | 45 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 9 / 60 | 8 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Change From Baseline in Schiff Sensitivity Score on Day 14
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Dentifrice | Change From Baseline in Schiff Sensitivity Score on Day 14 | At Baseline | 2.51 score on a scale | Standard Deviation 0.437 |
| Experimental Dentifrice | Change From Baseline in Schiff Sensitivity Score on Day 14 | At Day 14 | 1.16 score on a scale | Standard Deviation 0.774 |
| Experimental Dentifrice | 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 |
| Reference Dentifrice | Change From Baseline in Schiff Sensitivity Score on Day 14 | At Baseline | 2.51 score on a scale | Standard Deviation 0.446 |
| Reference Dentifrice | Change From Baseline in Schiff Sensitivity Score on Day 14 | At Day 14 | 1.35 score on a scale | Standard Deviation 0.901 |
| Reference Dentifrice | Change From Baseline in Schiff Sensitivity Score on Day 14 | Change from Baseline on Day 14 | -1.16 score on a scale | Standard Deviation 0.762 |
Comparison: H0 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is zero.~H1 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is not zero.p-value: 0.177495% CI: [-0.46, 0.09]ANCOVA
Secondary
Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3
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 indicate improvement in sensitivity.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Dentifrice | 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 |
| Experimental Dentifrice | 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 0.66 |
| Experimental Dentifrice | 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 |
| Experimental Dentifrice | 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 |
| Reference Dentifrice | Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | Change from baseline on Day 3 | -0.74 score on a scale | Standard Deviation 0.568 |
| Reference Dentifrice | Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | After 5 minutes of brushing | 1.92 score on a scale | Standard Deviation 0.737 |
| Reference Dentifrice | Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | On Day 3 | 1.77 score on a scale | Standard Deviation 0.785 |
| Reference Dentifrice | Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | Change after 5 minutes of brushing | -0.59 score on a scale | Standard Deviation 0.571 |
Secondary
Change From Baseline in Tactile (Yeaple) Pain Threshold on 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.
Time frame: Baseline, post first brushing (after 5 minutes), Day 3 and Day 14
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Dentifrice | 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 |
| Experimental Dentifrice | 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 |
| Experimental Dentifrice | 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 |
| Experimental Dentifrice | 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 |
| Experimental Dentifrice | 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 |
| Experimental Dentifrice | 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 |
| Experimental Dentifrice | 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 |
| Reference Dentifrice | 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 | 12.3 gram (g) | Standard Deviation 21.68 |
| Reference Dentifrice | Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 | At Baseline | 11.5 gram (g) | Standard Deviation 2.65 |
| Reference Dentifrice | 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 | 16.7 gram (g) | Standard Deviation 11.19 |
| Reference Dentifrice | 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 | 5.2 gram (g) | Standard Deviation 10.93 |
| Reference Dentifrice | Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 | On Day 3 | 18.6 gram (g) | Standard Deviation 16.73 |
| Reference Dentifrice | 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 | 7.1 gram (g) | Standard Deviation 16.48 |
| Reference Dentifrice | Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 | On Day 14 | 23.8 gram (g) | Standard Deviation 22.33 |