Dentinal Sensitivity, Hypersensitivity
Conditions
Keywords
dentinal, hypersensitivity
Brief summary
A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.
Interventions
DRUGTest Toothpaste
0.454% stannous fluoride toothpaste
0.76% sodium monofluorophosphate toothpaste
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: * Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years * Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. * Teeth having a gingival index score of less than or equal to 1 * Teeth with a clinical mobility less than or equal to 1 * sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity as measured by tactile stimulus (Yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (Schiff Sensitivity Score ≥ 2). Exclusion: * Presence of chronic debilitating disease which could affect study outcomes. * Any condition which 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, or not expected to respond to treatment with an over-the counter dentifrice. * Daily doses of a medication which could interfere with the perception of pain. * Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline. * Individuals who require antibiotic prophylaxis for dental procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment | Baseline and immediately after treatment administration | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3 | Baseline and Day 3 | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline. |
| Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14 | Baseline and Day 14 | Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline. |
| Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment | Baseline and immediately after treatment administration | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline. |
| Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3 | Baseline and Day 3 | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline. |
| Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14 | Baseline and Day 14 | Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the clinical site
Participants by arm
| Arm | Count |
|---|---|
| Test Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. | 59 |
| Negative Control Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily | 59 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Test | Negative Control | Total |
|---|---|---|---|
| Age Continuous | 35.7 Years STANDARD_DEVIATION 10.65 | 37.0 Years STANDARD_DEVIATION 9.98 | 36.3 Years STANDARD_DEVIATION 10.3 |
| Region of Enrollment USA | 59 Participants | 59 Participants | 118 Participants |
| Sex: Female, Male Female | 37 Participants | 37 Participants | 74 Participants |
| Sex: Female, Male Male | 22 Participants | 22 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 59 | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 |
Outcome results
Primary
Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.
Time frame: Baseline and immediately after treatment administration
Population: Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Test | Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment | -0.42 units on a scale |
| Negative Control | Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment | -0.32 units on a scale |
Comparison: Null hypothesis is no difference between treatments. Tests were 2-sided.p-value: 0.229495% CI: [-0.26, 0.06]ANCOVA
Secondary
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline.
Time frame: Baseline and immediately after treatment administration
Population: ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment | 3.73 units on a scale | 95% Confidence Interval 5.539 |
| Negative Control | Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment | 3.81 units on a scale | 95% Confidence Interval 7.505 |
Comparison: Null hypothesis was no difference between treatments. Tests were 2-sided.p-value: 0.944595% CI: [-2.49, 2.32]ANCOVA
Secondary
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline.
Time frame: Baseline and Day 14
Population: ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14 | 15.85 units on a scale | 95% Confidence Interval 12.6 |
| Negative Control | Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14 | 7.16 units on a scale | 95% Confidence Interval 13.249 |
Comparison: Null hypothesis was no difference between treatments. Tests were 2-sided.p-value: 0.000495% CI: [3.96, 13.43]ANCOVA
Secondary
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline.
Time frame: Baseline and Day 3
Population: ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3 | 4.83 units on a scale | 95% Confidence Interval 7.19 |
| Negative Control | Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3 | 6.90 units on a scale | 95% Confidence Interval 10.63 |
Comparison: Null hypothesis was no difference between treatments. Tests were 2-sided.p-value: 0.2295% CI: [-5.38, 1.25]ANCOVA
Secondary
Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline.
Time frame: Baseline and Day 14
Population: ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14 | -1.24 units on a scale | 95% Confidence Interval 0.604 |
| Negative Control | Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14 | -0.72 units on a scale | 95% Confidence Interval 0.622 |
Comparison: Null hypothesis was no difference between treatments. Tests were 2-sided.p-value: <0.000195% CI: [-0.74, -0.3]ANCOVA
Secondary
Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline.
Time frame: Baseline and Day 3
Population: ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3 | -0.57 units on a scale | 95% Confidence Interval 0.515 |
| Negative Control | Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3 | -0.45 units on a scale | 95% Confidence Interval 0.478 |
Comparison: Null hypothesis was no difference between treatments. Tests were 2-sided.p-value: 0.179295% CI: [-0.3, 0.06]ANCOVA