Dentin Sensitivity
Conditions
Brief summary
The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth) study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.
Interventions
3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride
DRUGStandard fluoride dentifrice
Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants in good general health, with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years. * Participants with minimum of 20 natural teeth. * At screening, a minimum of four, non-adjacent teeth. 1. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. 2. Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1. 3. Teeth that are determined to be sensitive by the participant following a 1 second air blast to the cervical margin.
Exclusion criteria
* 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 dry mouth. * Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening. * In the 8 weeks prior to screening use of an oral care product indicated for the relief of DH.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Baseline to 8 week | The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 is indicative of an imrpovement in sensitivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Baseline to 4 week | The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 is indicative of an imrpovement in sensitivity. |
| Mean Change From Baseline in Tactile Threshold at Week 8 | Baseline to 8 week | The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. |
| Mean Change From Baseline in Tactile Threshold at Week 4 | Baseline to 4 week | The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. |
| Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8 | Baseline to 8 week | Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity. |
| Mean Change From Baseline in VRS at Week 4 | Baseline to 4 week | Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity. |
Countries
United States
Participant flow
Recruitment details
The participants were recruited at a clinical site in the USA
Participants by arm
| Arm | Count |
|---|---|
| Dentifrice Plus Oral Rinse 3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice | 95 |
| Dentifrice Alone Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP) | 96 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Dentifrice Plus Oral Rinse | Dentifrice Alone | Total |
|---|---|---|---|
| Age, Continuous | 41.7 Years STANDARD_DEVIATION 8.62 | 39.7 Years STANDARD_DEVIATION 8.14 | 40.7 Years STANDARD_DEVIATION 8.42 |
| Sex: Female, Male Female | 81 Participants | 79 Participants | 160 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 95 | 7 / 96 |
| serious Total, serious adverse events | 0 / 95 | 0 / 96 |
Outcome results
Primary
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 is indicative of an imrpovement in sensitivity.
Time frame: Baseline to 8 week
Population: The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Dentifrice Plus Oral Rinse | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | -1.47 Score on scale | Standard Error 0.065 |
| Dentifrice Alone | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | -0.37 Score on scale | Standard Error 0.065 |
p-value: 0.000195% CI: [-1.28, -0.92]ANCOVA
Secondary
Mean Change From Baseline in Schiff Sensitivity Score at Week 4
The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 is indicative of an imrpovement in sensitivity.
Time frame: Baseline to 4 week
Population: The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dentifrice Plus Oral Rinse | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | -0.94 Scores on scale | Standard Deviation 0.719 |
| Dentifrice Alone | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | -0.31 Scores on scale | Standard Deviation 0.542 |
Secondary
Mean Change From Baseline in Tactile Threshold at Week 4
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Time frame: Baseline to 4 week
Population: The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dentifrice Plus Oral Rinse | Mean Change From Baseline in Tactile Threshold at Week 4 | 14.11 Gram (g) | Standard Deviation 21.276 |
| Dentifrice Alone | Mean Change From Baseline in Tactile Threshold at Week 4 | 0.74 Gram (g) | Standard Deviation 4.434 |
Secondary
Mean Change From Baseline in Tactile Threshold at Week 8
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Time frame: Baseline to 8 week
Population: The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dentifrice Plus Oral Rinse | Mean Change From Baseline in Tactile Threshold at Week 8 | 31.32 Gram(g) | Standard Deviation 27.869 |
| Dentifrice Alone | Mean Change From Baseline in Tactile Threshold at Week 8 | 3.74 Gram(g) | Standard Deviation 13.188 |
Secondary
Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8
Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.
Time frame: Baseline to 8 week
Population: The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dentifrice Plus Oral Rinse | Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8 | -3.05 Score on scale | Standard Deviation 2.038 |
| Dentifrice Alone | Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8 | -1.05 Score on scale | Standard Deviation 1.673 |
Secondary
Mean Change From Baseline in VRS at Week 4
Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.
Time frame: Baseline to 4 week
Population: The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dentifrice Plus Oral Rinse | Mean Change From Baseline in VRS at Week 4 | -1.64 Score on scale | Standard Deviation 1.651 |
| Dentifrice Alone | Mean Change From Baseline in VRS at Week 4 | -0.86 Score on scale | Standard Deviation 1.295 |