Dentine Hypersensitivity, Dental Pain
Conditions
Keywords
sensitivity, occlusion
Brief summary
To evaluate the efficacy of two different concentrations of a tubule occlusion agent - calcium sodium phosphosilicate in treatment of dentine hypersensitivity
Detailed description
Dentine hypersensitivity is characterized by short, sharp pain arising from exposed dentine typically in response to chemical, thermal, tactile or osmotic stimuli. Dentine hypersensitivity may be treated by either making the nerve in the tooth less sensitive or by occluding the tubules to limit exposure of the nerve to external stimuli. Bioactive and biocompatible glasses react with oral fluid to deposit a mineral that is chemically analogous to that found in both enamel and dentine thus preventing exposure of the nerve to external stimuli. A number of controlled clinical trials have been reported indicating that a calcium sodium phosphosilicate bioactive glass, when incorporated into a toothpaste formulation, significantly reduce pain from dentine hypersensitivity. The aim of this study is to evaluate the effectiveness of two currently marketed toothpastes, containing 5% calcium sodium phosphosilicate and the other containing 7.5% calcium sodium phosphosilicate in the treatment of dentine hypersensitivity compared to a matched placebo control.
Interventions
DEVICE5% calcium sodium phosphosilicate toothpaste
Low concentration calcium sodium phosphosilicate tubule occlusion agent
DEVICE7.5% calcium sodium phosphosilicate toothpaste
High concentration calcium sodium phosphosilicate tubule occlusion agent
DEVICEPlacebo toothpaste
Placebo toothpaste
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. 2. Age: Aged between 20 - 50 years. 3. General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history. 4. Contraception: Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. 5. Erosion/Abrasion/Recession:Study teeth must show signs of facial/cervical erosion, abrasion and/or gingival recession. 6. Gingival Health / Tooth Mobility Grade:Study teeth must have Löe and Silness Gingival Index (GI) score less than or equal to 2 and clinical mobility less than or equal to grade I. 7. Current Product Use: Participants must have been using the same brand of toothpaste for at least 2 months and should not have used desensitizing toothpaste during the 4 weeks preceding screening. Participants will be required to bring in their current toothpaste(s) in order to verify the ingredients. 8. VAS Training: Successfully completes the VAS training exercise at Screening. 9. Sensitivity: Self-reported history of dentinal hypersensitivity and a primary complaint of sensitive teeth lasting a maximum of 10 years. At Screening: A minimum of 5 evaporative (air) sensitive lateral incisors, canines or pre-molars must display a response greater than 25 mm on a 100 mm VAS. At Baseline: A minimum of 3 of the 5 evaporative (air) sensitive teeth identified at screening must display a response greater than 25 mm on a 100 mm VAS. All teeth meeting the sensitivity Inclusion Criteria will be followed and assessed using both efficacy parameters. 10. Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
Exclusion criteria
1. Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. 2. Breast-feeding: Women who are breast-feeding. 3. Medical History: a) Chronic debilitating disease is present b)Chronic disease or other condition is present that is associated with intermittent episodes or constant daily pain, such as arthritis, low back pain, dysmenorrhea, etc. 4. Medications: Daily doses of medication, which in the opinion of the investigator, might interfere with the perception of pain, are being taken. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory drugs. 5. Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an over-the- counter (OTC) dentifrice in the opinion of the investigator. b) Teeth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns, orthodontic bands, extensive caries or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine. c) Dental professional hygiene (includes dental prophylaxis, irrigation, and intensive anti-microbial/anti-biotic therapy) within 14 days of the screening visit. d) Presence of dental implants. e) Lip or tongue piercings. f) Periodontal surgical history within the past 6 months or have been scaled /root planed within the past 3 months. 6. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. 7. Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.b) Previous participation in this study. 8. Xerostomia: Any condition or medication that causes xerostomia. 9. Personnel: An employee of the sponsor or the study site or members of their immediate family. 10. Other: Any subject who in the opinion of the investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15 | Baseline to Day 15 | Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment. |
| Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15 | Baseline to Day 15 | Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7 | Baseline to Day 7 | Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment. |
| Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7 | Baseline to Day 7 | Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10 | Baseline to Day 10 | Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment. |
| Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10 | Baseline to Day 10 | Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment. |
| Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3 | Baseline to Day 3 | Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment. |
| Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 3 | Baseline to Day 3 | Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
During the first 4 weeks of the study all participants brushed with an acclimatization toothpaste (sodium fluoride \[NaF\] toothpaste containing 1100 parts per million \[ppm\] fluoride \[F\]) for maintaining wash-out period and standardizing the oral conditions.
Participants by arm
| Arm | Count |
|---|---|
| 5% Sodium Calcium Phosphosilicate Toothpaste Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free. | 66 |
| 7.5% Sodium Calcium Phosphosilicate Toothpaste Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free. | 63 |
| Placebo Toothpaste Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free. | 66 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 5% Sodium Calcium Phosphosilicate Toothpaste | 7.5% Sodium Calcium Phosphosilicate Toothpaste | Placebo Toothpaste | Total |
|---|---|---|---|---|
| Age Continuous | 38.30 years STANDARD_DEVIATION 8.925 | 37.63 years STANDARD_DEVIATION 8.92 | 36.61 years STANDARD_DEVIATION 9.885 | 37.51 years STANDARD_DEVIATION 9.239 |
| Sex: Female, Male Female | 51 Participants | 49 Participants | 54 Participants | 154 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 12 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 63 | 3 / 66 | 3 / 66 |
| serious Total, serious adverse events | 0 / 63 | 0 / 66 | 0 / 66 |
Outcome results
Primary
Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15
Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Time frame: Baseline to Day 15
Population: ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 7.5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15 | -32.8 Units on a scale |
| 5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15 | -32.2 Units on a scale |
| Placebo Toothpaste | Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15 | -32.3 Units on a scale |
Comparison: The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.975995% CI: [-6.34, 6.54]ANCOVA
Comparison: The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.890395% CI: [-6.97, 6.06]ANCOVA
Comparison: Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.p-value: 0.866295% CI: [-7.04, 5.93]ANCOVA
Primary
Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Time frame: Baseline to Day 15
Population: Intention to treat (ITT) population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 7.5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15 | -26.1 Units on a scale |
| 5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15 | -28.4 Units on a scale |
| Placebo Toothpaste | Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15 | -26.2 Units on a scale |
Comparison: The null hypothesis was no diference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.362895% CI: [-6.7, 2.46]ANCOVA
Comparison: The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.936195% CI: [-4.45, 4.83]ANCOVA
Comparison: The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.325795% CI: [-2.31, 6.92]ANCOVA
Secondary
Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7
Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Time frame: Baseline to Day 7
Population: ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 7.5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7 | -21.5 Units on a scale |
| 5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7 | -22.5 Units on a scale |
| Placebo Toothpaste | Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7 | -21.8 Units on a scale |
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.841995% CI: [-6.93, 5.66]ANCOVA
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.914795% CI: [-6.03, 6.72]ANCOVA
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.7695% CI: [-5.36, 7.33]ANCOVA
Secondary
Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Time frame: Baseline to Day 7
Population: ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 7.5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7 | -16.4 Units on a scale |
| 5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7 | -17.4 Units on a scale |
| Placebo Toothpaste | Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7 | -16.4 Units on a scale |
Comparison: The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.667495% CI: [-5.73, 3.68]ANCOVA
Comparison: The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.988895% CI: [-4.74, 4.81]ANCOVA
Comparison: The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.659995% CI: [-3.69, 5.81]ANCOVA
Other Pre-specified
Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10
Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Time frame: Baseline to Day 10
Population: ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 7.5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10 | -34.7 Units on a scale |
| 5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10 | -31.3 Units on a scale |
| Placebo Toothpaste | Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 10 | -34.7 Units on a scale |
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.594695% CI: [-9.32, 16.09]ANCOVA
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.994495% CI: [-12.51, 12.6]ANCOVA
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.599895% CI: [-16.06, 9.38]ANCOVA
Other Pre-specified
Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 3
Response of exposed dentine surface to application of 1 ml freshly melted ice cold water was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Time frame: Baseline to Day 3
Population: ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 7.5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 3 | -19.3 Units on a scale |
| 5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 3 | -16.9 Units on a scale |
| Placebo Toothpaste | Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 3 | -17.6 Units on a scale |
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.90695% CI: [-10.38, 11.68]ANCOVA
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.757595% CI: [-12.63, 9.25]ANCOVA
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.672795% CI: [-13.42, 8.73]ANCOVA
Other Pre-specified
Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Time frame: Baseline to Day 10
Population: ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 7.5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10 | -28.7 Units on a scale |
| 5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10 | -22.7 Units on a scale |
| Placebo Toothpaste | Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 10 | -28.2 Units on a scale |
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.912495% CI: [-8.28, 9.24]ANCOVA
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance levelp-value: 0.908395% CI: [-9.13, 8.14]ANCOVA
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.823195% CI: [-9.73, 7.77]ANCOVA
Other Pre-specified
Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Time frame: Baseline to Day 3
Population: ITT population subset: A subset of randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 7.5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3 | -13.5 Units on a scale |
| 5% Sodium Calcium Phosphosilicate Toothpaste | Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3 | -12.3 Units on a scale |
| Placebo Toothpaste | Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 3 | -11.1 Units on a scale |
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.795295% CI: [-10.51, 8.09]ANCOVA
Comparison: The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.60195% CI: [-11.56, 6.76]ANCOVA
Comparison: Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.p-value: 0.797695% CI: [-10.48, 8.1]ANCOVA