Dentin Sensitivity
Conditions
Brief summary
To investigate the efficacy of an experimental oral rinse, containing 1.5% potassium oxalate (KOX) and 0 parts per million (ppm) fluoride in relieving dentine hypersensitivity (DH) after 8 weeks use compared with a placebo oral rinse and a commercialized fluoride oral rinse.
Detailed description
This will be a single centre, eight week, randomized, examiner-blind, three treatment, parallel group, stratified study. It will be conducted in healthy participants, with at least two sensitive teeth that meet all of the study criteria at the Screening and Baseline visits. DH will be assessed at Baseline, and after 4 and 8 weeks twice daily treatment.
Interventions
DEVICEPotassium oxalate
Oral rinse containing 1.5 percent (%) KOX and 0 ppm fluoride
DRUGSodium fluoride
Oral rinse containing 0.02% weight by weight (w/w) sodium fluoride (NaF)
OTHERPlacebo
Oral rinse containing 0% KOX and 0 ppm 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 oral Examination and 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 DH lasting more than six months but not more than 10 Years, b) Minimum of 20 natural teeth, c) Minimum of 4 accessible non-adjacent teeth (incisors, canines, premolars), 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 and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Schiff sensitivity score ≥ 2). * Dental Health at Baseline: Minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), 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. * Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone or injectable progestogen or implants of levonorgestrel or estrogenic vaginal ring or percutaneous contraceptive patches or intrauterine device or intrauterine system or double barrier method (condom or occlusive cap \[diaphragm or cervical vault caps\] plus spermicidal agent \[foam, gel, film, cream, suppository\]) or male partner sterilization prior to the female participant's entry into the study, and this male is the sole partner for that participant). * Participant will be current and regular (twice daily), users of an over the counter (OTC) Monograph or cosmetic oral rinse. * Participant will be cell phone owners so that they can contactable by SMS.
Exclusion criteria
* A woman who is known to be pregnant or who is intending to become pregnant over the duration of the study. * A woman who is 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 or 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. * Any condition which, in the opinion of the investigator, causes xerostomia. * Dental prophylaxis within 4 weeks of Screening. * Tongue or lip piercing. * Desensitizing treatment within 8 weeks of Screening (professional sensitivity, treatments and non-dentifrice 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 and any teeth whitening procedures 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, dental implants, 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 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 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 | Week 8 | 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 did 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 requested 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 will be indicative of an improvement in sensitivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Tactile Threshold | Week 8 | The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) 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 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from one center in USA.
Pre-assignment details
A total of 123 participates were screened, out of which 89 participants were enrolled and randomized in the study. 34 participants were not randomized as all the 34 participants did not meet study criteria.
Participants by arm
| Arm | Count |
|---|---|
| Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (1.5% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. | 43 |
| Negative Control (0.02% w/w Sodium Fluoride) Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0.02% w/w sodium fluoride) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. | 23 |
| Placebo (0% KOX, 0 Ppm Fluoride, pH 7) Participants rinsed twice daily (morning and evening) with 10 mL of oral rinse (0% KOX, 0 ppm fluoride, pH 7) for 60 seconds using standard fluoride dentifrice and then expectorated. No further rinsing with water was allowed after use of the oral rinse. This regimen was performed twice daily for 8 weeks. | 23 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) | Negative Control (0.02% w/w Sodium Fluoride) | Placebo (0% KOX, 0 Ppm Fluoride, pH 7) | Total |
|---|---|---|---|---|
| Age, Customized | 46.0 Years STANDARD_DEVIATION 9.27 | 41.5 Years STANDARD_DEVIATION 9.76 | 43.0 Years STANDARD_DEVIATION 8.75 | 44.1 Years STANDARD_DEVIATION 9.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 23 Participants | 22 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 20 Participants | 20 Participants | 77 Participants |
| Sex: Female, Male Female | 37 Participants | 19 Participants | 23 Participants | 79 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 0 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 4 / 43 | 0 / 23 | 2 / 23 |
| serious Total, serious adverse events | 0 / 43 | 0 / 23 | 0 / 23 |
Outcome results
Primary
Change From Baseline in Schiff Sensitivity Score
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 did 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 requested 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 will be indicative of an improvement in sensitivity.
Time frame: Week 8
Population: The Intent-to-Treat (ITT) (N=85) population comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) | Change From Baseline in Schiff Sensitivity Score | Schiff score at baseline | 2.59 Score on Scale | Standard Deviation 0.382 |
| Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) | Change From Baseline in Schiff Sensitivity Score | Change from baseline in Schiff score at Week 8 | -1.94 Score on Scale | Standard Deviation 0.773 |
| Negative Control (0.02% w/w Sodium Fluoride) | Change From Baseline in Schiff Sensitivity Score | Schiff score at baseline | 2.68 Score on Scale | Standard Deviation 0.406 |
| Negative Control (0.02% w/w Sodium Fluoride) | Change From Baseline in Schiff Sensitivity Score | Change from baseline in Schiff score at Week 8 | -0.75 Score on Scale | Standard Deviation 0.866 |
| Placebo (0% KOX, 0 Ppm Fluoride, pH 7) | Change From Baseline in Schiff Sensitivity Score | Schiff score at baseline | 2.52 Score on Scale | Standard Deviation 0.361 |
| Placebo (0% KOX, 0 Ppm Fluoride, pH 7) | Change From Baseline in Schiff Sensitivity Score | Change from baseline in Schiff score at Week 8 | -0.64 Score on Scale | Standard Deviation 0.848 |
Comparison: Test Product versus Negative Control at Week 8 is a primary endpoint comparison.p-value: <0.000195% CI: [-1.657, -0.782]ANCOVA
p-value: <0.000195% CI: [-1.705, -0.858]ANCOVA
Comparison: Test Product versus Combined Control (Placebo and Negative Control) group was obtained by using estimates statement in the ANCOVA model.p-value: <0.000195% CI: [-1.6, -0.901]ANCOVA
Secondary
Change From Baseline in Tactile Threshold
The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) 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 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: Week 8
Population: The ITT (N=85) population included all participants who were randomized received at least one dose of investigational product and had at least one post-baseline efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) | Change From Baseline in Tactile Threshold | Tactile threshold at baseline | 10.35 Grams | Standard Deviation 1.289 |
| Test Product (1.5% KOX, 0 Ppm Fluoride, pH 7) | Change From Baseline in Tactile Threshold | Change from baseline at Week 8 | 61.28 Grams | Standard Deviation 22.095 |
| Negative Control (0.02% w/w Sodium Fluoride) | Change From Baseline in Tactile Threshold | Tactile threshold at baseline | 10.25 Grams | Standard Deviation 1.118 |
| Negative Control (0.02% w/w Sodium Fluoride) | Change From Baseline in Tactile Threshold | Change from baseline at Week 8 | 23.75 Grams | Standard Deviation 35.499 |
| Placebo (0% KOX, 0 Ppm Fluoride, pH 7) | Change From Baseline in Tactile Threshold | Tactile threshold at baseline | 10.23 Grams | Standard Deviation 1.066 |
| Placebo (0% KOX, 0 Ppm Fluoride, pH 7) | Change From Baseline in Tactile Threshold | Change from baseline at Week 8 | 11.59 Grams | Standard Deviation 26.788 |
p-value: <0.000495% CI: [22.916, 51.995]ANCOVA
p-value: <0.000195% CI: [35.791, 63.966]ANCOVA
Comparison: Test Product versus Combined Control (Placebo and Negative Control) group is obtained by using estimates statement in the ANCOVA modelp-value: <0.000195% CI: [32.001, 55.334]ANCOVA