Dentin Sensitivity
Conditions
Brief summary
This study will investigate the efficacy of an experimental dentifrice containing 0.454% weight/weight (w/w) stannous fluoride in relieving dentine hypersensitivity (DH) after twice daily brushing, over a 2 week treatment period compared with a standard fluoride dentifrice.
Interventions
OTHER0.454% w/w stannous fluoride (1100ppm fluoride)
Dentifrice containing 0.454% w/w stannous fluoride (1100ppm fluoride)
OTHER0.76% sodium monofluorophosphate (1000ppm fluoride)
Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Participant is male or female aged between 18 and 65 years inclusive. * Good general and mental health with, in the opinion of the investigator or medically qualified designee. * No clinically significant and relevant abnormalities in medical history or upon oral examination. * Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures and requirements. * Self-reported history of dentinal hypersensitivity (DH) lasting more than(\>) six months but not \> 10 years. * Good general oral health, with a minimum of 20 natural teeth. * Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants at screening and minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) at baseline.
Exclusion criteria
* Women who are pregnant or breast-feeding . * Daily doses of medication/treatments which, in the opinion of the Investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs. * Currently taking antibiotics or has taken antibiotics within two weeks of Baseline. * Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia. * Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts. * 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. * 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 (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit. * Previous participation in this study. * Recent history (within the last year) of alcohol or other substance abuse. * Dental prophylaxis within four weeks of Screening, tongue or lip piercing or presence of dental implants. * Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments). * 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 eight weeks of Screening. * Tooth with evidence of current or recent caries, or reported treatment of decay within 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 toothpaste in the opinion of the Investigator. * Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening. * 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 Day 7 | Baseline, Day 7 | 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. |
| Change From Baseline in Tactile Threshold on Day 7 and 14 | Baseline, Day 7 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
United Kingdom
Participant flow
Recruitment details
Participants were recruited at one center (2 sites) in United Kingdom.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Test Dentifrice 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. | 70 |
| Control Dentifrice 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. | 69 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Protocol Violation | 3 | 0 |
| Overall Study | Withdrawal of Consent | 1 | 1 |
Baseline characteristics
| Characteristic | Test Dentifrice | Total | Control Dentifrice |
|---|---|---|---|
| Age, Continuous | 39.9 Years STANDARD_DEVIATION 10.72 | 39.9 Years STANDARD_DEVIATION 10.11 | 39.9 Years STANDARD_DEVIATION 9.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 137 Participants | 69 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 | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 14 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 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 | 57 Participants | 116 Participants | 59 Participants |
| Schiff Sensitivity Score at Baseline | 2.80 score on a scale STANDARD_DEVIATION 0.323 | 2.81 score on a scale STANDARD_DEVIATION 0.314 | 2.83 score on a scale STANDARD_DEVIATION 0.307 |
| Sex: Female, Male Female | 53 Participants | 110 Participants | 57 Participants |
| Sex: Female, Male Male | 17 Participants | 29 Participants | 12 Participants |
| Tactile Threshold at Baseline | 11.50 gram (g) STANDARD_DEVIATION 2.739 | 11.76 gram (g) STANDARD_DEVIATION 2.878 | 12.03 gram (g) STANDARD_DEVIATION 3.01 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 70 |
| other Total, other adverse events | 15 / 72 | 10 / 70 |
| serious Total, serious adverse events | 0 / 72 | 0 / 70 |
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 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice | Change From Baseline in Schiff Sensitivity Score on Day 14 | -1.01 score on a scale | Standard Deviation 1.093 |
| Control Dentifrice | Change From Baseline in Schiff Sensitivity Score on Day 14 | -0.88 score on a scale | Standard Deviation 1.11 |
p-value: 0.519195% CI: [-0.497, 0.252]ANCOVA
Secondary
Change From Baseline in Schiff Sensitivity Score on Day 7
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 7
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 7.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Dentifrice | Change From Baseline in Schiff Sensitivity Score on Day 7 | -0.49 score on a scale | Standard Deviation 0.807 |
| Control Dentifrice | Change From Baseline in Schiff Sensitivity Score on Day 7 | -0.54 score on a scale | Standard Deviation 0.785 |
Secondary
Change From Baseline in Tactile Threshold on Day 7 and 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, 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Dentifrice | 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 |
| Test Dentifrice | 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 |
| Control Dentifrice | Change From Baseline in Tactile Threshold on Day 7 and 14 | Change from baseline on Day 7(n=70,69) | 10.29 g | Standard Deviation 17.634 |
| Control Dentifrice | Change From Baseline in Tactile Threshold on Day 7 and 14 | Change from baseline on Day 14(n=68,68) | 18.90 g | Standard Deviation 23.081 |