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
Detailed description
This will be a single centre, three day, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participants with at least two sensitive teeth that meet all the criteria at the screening and baseline (pre-treatment) visits. Dentinal hypersensitivity will be assessed at baseline (pre-treatment), post-treatment and after 3 days twice daily brushing
Interventions
0.76% w/w sodium monofluorophosphate containing 1000ppm fluoride
OTHERstannous fluoride
0.454% weight by weight (w/w) stannous fluoride containing 1100ppm 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 * Aged 18-65 years inclusive * Understands and is willing, able and likely to comply with all study procedures and restrictions * Good general and mental health with, in the opinion of the investigator or medically qualified designee: a) No clinically significant and relevant abnormalities of medical history or 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 * Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years * Minimum of 20 natural teeth * 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 MGI score =0 adjacent to the test area (exposed dentine) only \[Lobene, 1986\] and a clinical mobility of ≤1, Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response) * 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
* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study * Women who are breast-feeding * 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 * 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 or Any condition which, in the opinion of the investigator, causes xerostomia * Dental prophylaxis within 4 weeks of Screening or Tongue or lip piercing or presence of dental implants * Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening and teeth bleaching within 8 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 dentifrice in the opinion of the investigator * Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening (participants will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients) * 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 2 weeks of Baseline
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 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. |
| 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. |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited at single clinical site in Canada.
Pre-assignment details
A total of 229 participants were screened. Out of which 222 participants were randomized. 7 participants were not randomized because these participants did not meet study criteria.
Participants by arm
| Arm | Count |
|---|---|
| Stannous Fluoride Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental 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. | 111 |
| Sodium Monofluorophosphate Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing. | 111 |
| Total | 222 |
Baseline characteristics
| Characteristic | Stannous Fluoride | Total | Sodium Monofluorophosphate |
|---|---|---|---|
| Age, Continuous | 46.4 Years STANDARD_DEVIATION 10.77 | 47.0 Years STANDARD_DEVIATION 10.85 | 47.6 Years STANDARD_DEVIATION 10.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 109 Participants | 219 Participants | 110 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 | 18 Participants | 33 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 56 Participants | 23 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 | 60 Participants | 133 Participants | 73 Participants |
| Schiff Sensitivity Score at Baseline | 2.50 Score on a Scale STANDARD_DEVIATION 0.484 | 2.48 Score on a Scale STANDARD_DEVIATION 0.472 | 2.46 Score on a Scale STANDARD_DEVIATION 0.461 |
| Sex: Female, Male Female | 82 Participants | 163 Participants | 81 Participants |
| Sex: Female, Male Male | 29 Participants | 59 Participants | 30 Participants |
| Tactile Sensitivity - Tactile Threshold at Baseline | 12.66 gram (g) STANDARD_DEVIATION 4.201 | 13.04 gram (g) STANDARD_DEVIATION 4.24 | 13.42 gram (g) STANDARD_DEVIATION 4.263 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 111 | 0 / 111 |
| serious Total, serious adverse events | 0 / 111 | 0 / 111 |
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 | -0.40 Score on a scale | Standard Deviation 0.485 |
| Sodium Monofluorophosphate | Change From Baseline in Schiff Sensitivity Score on Day 3 | 0.00 Score on a scale | Standard Deviation 0.257 |
Comparison: Statistical analyses was 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: [-0.505, -0.3]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 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 | -0.17 Score on a scale | Standard Deviation 0.34 |
| Sodium Monofluorophosphate | Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application | -0.02 Score on a scale | Standard Deviation 0.269 |
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.
Time frame: Baseline to Day 3
Population: Analysis for this outcome was performed 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stannous Fluoride | Change From Baseline in Tactile Threshold on Day 3 | 3.69 g | Standard Deviation 4.941 |
| Sodium Monofluorophosphate | Change From Baseline in Tactile Threshold on Day 3 | 0.09 g | Standard Deviation 2.521 |
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.
Time frame: Baseline to 60 seconds post first treatment
Population: Analysis for this outcome was performed 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stannous Fluoride | Change From Baseline in Tactile Threshold Post First Treatment by Direct Application | 1.71 g | Standard Deviation 3.268 |
| Sodium Monofluorophosphate | Change From Baseline in Tactile Threshold Post First Treatment by Direct Application | 0.18 g | Standard Deviation 2.328 |