Dentin Sensitivity
Conditions
Brief summary
This single centre, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use compared with a standard fluoride dentifrice.
Interventions
Experimental dentifrice containing 0.454% w/w stannous fluoride (1100ppm)
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 * Good general and mental health with, in the opinion of the investigator or medically qualified designee: A. No clinically significant and relevant abnormalities in medical history or upon oral examination. B. Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements. \- Dental health At Screening: A. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years. B. Good general oral health, with a minimum of 20 natural teeth. C. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria: * Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR). * Tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1. * Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response). At Baseline: D. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria: \- Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff Sensitivity Score ≥ 2)
Exclusion criteria
* Pregnant or breast feeding women * Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. * 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 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score on Day 3 | Baseline to Day 3 | The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application | Baseline to 60 seconds post first treatment | The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity. |
| Change From Baseline in Tactile Threshold Post First Treatment by Direct Application | Baseline to 60 seconds post first treatment | 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 participant whether the sensation caused discomfort. The pressure setting at which the participant gives 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. |
| Change From Baseline in Tactile Threshold on Day 3 | Baseline to Day 3 | 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 participant whether the sensation caused discomfort. The pressure setting at which the participant gives 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited at one center in United Kingdom.
Pre-assignment details
A total of 263 participants were screened, 233 were randomized and 232 completed the study. One participant withdrew from study due to adverse event (AE).
Participants by arm
| Arm | Count |
|---|---|
| Stannous Fluoride Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing. | 117 |
| Sodium Monofluorophosphate Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing. | 116 |
| Total | 233 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Stannous Fluoride | Total | Sodium Monofluorophosphate |
|---|---|---|---|
| Age, Continuous | 34.3 Years STANDARD_DEVIATION 12.92 | 33.5 Years STANDARD_DEVIATION 12.24 | 32.8 Years STANDARD_DEVIATION 11.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 233 Participants | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 20 Participants | 28 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 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 | 93 Participants | 195 Participants | 102 Participants |
| Schiff Sensitivity Score at Baseline | 2.12 Score on a scale STANDARD_DEVIATION 0.3 | 2.12 Score on a scale STANDARD_DEVIATION 0.299 | 2.12 Score on a scale STANDARD_DEVIATION 0.299 |
| Sex: Female, Male Female | 81 Participants | 166 Participants | 85 Participants |
| Sex: Female, Male Male | 36 Participants | 67 Participants | 31 Participants |
| Tactile Sensitivity - Tactile Threshold at Baseline | 10.85 grams (g) STANDARD_DEVIATION 2.482 | 10.77 grams (g) STANDARD_DEVIATION 2.285 | 10.69 grams (g) STANDARD_DEVIATION 2.074 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 117 | 0 / 116 |
| other Total, other adverse events | 1 / 117 | 3 / 116 |
| serious Total, serious adverse events | 1 / 117 | 0 / 116 |
Outcome results
Primary
Change From Baseline in Schiff Sensitivity Score on Day 3
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.
Time frame: Baseline to Day 3
Population: Analysis for this outcome was performed on intent-to-treat (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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stannous Fluoride | Change From Baseline in Schiff Sensitivity Score on Day 3 | -1.40 Score on a scale | Standard Deviation 0.55 |
| Sodium Monofluorophosphate | Change From Baseline in Schiff Sensitivity Score on Day 3 | -0.38 Score on a scale | Standard Deviation 0.501 |
Comparison: All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.p-value: <0.000195% CI: [-1.15, -0.882]ANCOVA
Secondary
Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application
The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.
Time frame: Baseline to 60 seconds post first treatment
Population: Analysis for this outcome was performed on intent-to-treat (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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stannous Fluoride | Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application | -0.89 Score on a Scale | Standard Deviation 0.533 |
| Sodium Monofluorophosphate | Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application | -0.17 Score on a Scale | Standard Deviation 0.329 |
Secondary
Change From Baseline in Tactile Threshold on Day 3
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 participant whether the sensation caused discomfort. The pressure setting at which the participant gives 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 Day 3
Population: Analysis for this outcome was performed on intent-to-treat (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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stannous Fluoride | Change From Baseline in Tactile Threshold on Day 3 | 35.47 g | Standard Deviation 21.131 |
| Sodium Monofluorophosphate | Change From Baseline in Tactile Threshold on Day 3 | 6.55 g | Standard Deviation 11.002 |
Secondary
Change From Baseline in Tactile Threshold Post First Treatment by Direct Application
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 participant whether the sensation caused discomfort. The pressure setting at which the participant gives 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 60 seconds post first treatment
Population: Analysis for this outcome was performed on intent-to-treat (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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stannous Fluoride | Change From Baseline in Tactile Threshold Post First Treatment by Direct Application | 19.49 g | Standard Deviation 16.392 |
| Sodium Monofluorophosphate | Change From Baseline in Tactile Threshold Post First Treatment by Direct Application | 3.66 g | Standard Deviation 6.704 |