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To evaluate the efficacy of two different concentrations of a tubule occlusion agent - calcium sodium phosphosilicate in treatment of dentine hypersensitivity
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5% calcium sodium phosphosilicate toothpaste | Active Comparator | Participants to brush their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. |
|
| 7.5% calcium sodium phosphosilicate toothpaste | Active Comparator | Participants to brush their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. |
|
| Placebo toothpaste | Placebo Comparator | Participants to brush their teeth for two minutes, twice daily for 15 days with placebo toothpaste. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% calcium sodium phosphosilicate toothpaste | Device | Low concentration calcium sodium phosphosilicate tubule occlusion agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 15 |
| 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. | Baseline to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Park Research Center (UPRC) | Fort Wayne | Indiana | 46825 | United States |
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 were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 7.5% Sodium Calcium Phosphosilicate Toothpaste |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline to Day 15 |
|
All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
An issue with study product packaging was discovered post-study completion. The nature indicated that subject response was likely to have been liable to a positive bias. Efficacy cannot be considered as valid and no reliable conclusions possible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| D014098 | Toothache |
| D006967 | Hypersensitivity |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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| 7.5% calcium sodium phosphosilicate toothpaste | Device | High concentration calcium sodium phosphosilicate tubule occlusion agent |
|
| Placebo toothpaste | Device | Placebo toothpaste |
|
| Baseline to Day 7 |
| 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. | Baseline to Day 7 |
| Baseline to Day 10 |
| 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. | Baseline to Day 10 |
| 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. | Baseline to Day 3 |
| 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. | Baseline to Day 3 |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Safety population reported as treated- one randomized participant in the High concentration group received placebo and is included in the placebo count. | Count of Participants | Participants |
|
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. |
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline to Day 7 |
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|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline to Day 15 |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline to Day 7 |
|
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|
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline to Day 10 |
|
|
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline to Day 10 |
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|
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline to Day 3 |
|
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|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline to Day 3 |
|
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|
| 0 |
| 63 |
| 3 |
| 63 |
| EG001 | 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. | 0 | 66 | 3 | 66 |
| EG002 | 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. | 0 | 66 | 3 | 66 |
| Gingival Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Mouth Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | Systematic Assessment |
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| Pharyngitis Streptococcal | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Tonsilitis | Infections and infestations | Systematic Assessment |
|
| Sinus Headache | Nervous system disorders | Systematic Assessment |
|
| Sensitivity of teeth | Gastrointestinal disorders | Systematic Assessment |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.9888 | No adjustments for multiple comparisons. | Adjusted Mean Difference | 0.0 | 2-Sided | 95 | -4.74 | 4.81 | Difference is the high concentration minus placebo such that a positive difference favors the first named treatment. | No | Superiority or Other |
| The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.6599 | No adjustments for multiple comparisons. | Adjusted Mean Difference | 1.1 | 2-Sided | 95 | -3.69 | 5.81 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.8903 | No adjustments for multiple comparisons. | Adjusted Mean Difference | -0.5 | 2-Sided | 95 | -6.97 | 6.06 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.8662 | No adjustments for multiple comparisons | Adjusted mean difference | -0.6 | 2-Sided | 95 | -7.04 | 5.93 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.9147 | No adjustments for multiple comparisons. | Adjusted Mean Difference | 0.3 | 2-Sided | 95 | -6.03 | 6.72 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.7600 | No adjustments for multiple comparisons. | Adjusted Mean Difference | 1.0 | 2-Sided | 95 | -5.36 | 7.33 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.9083 | No adjustment was made for multiple comparisons. | Adjusted Mean Difference | -0.5 | 2-Sided | 95 | -9.13 | 8.14 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.8231 | No adjustment was made for multiple comparisons. | Adjusted Mean Difference | -1.0 | 2-Sided | 95 | -9.73 | 7.77 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.9944 | No adjustment was made for multiple comparisons. | Adjusted Mean Difference | 0.0 | 2-Sided | 95 | -12.51 | 12.60 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.5998 | No adjustment was made for multiple comparisons. | Adjusted Mean Difference | -3.3 | 2-Sided | 95 | -16.06 | 9.38 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.6010 | No adjustment was made for multiple comparisons. | Adjusted Mean Difference | -2.4 | 2-Sided | 95 | -11.56 | 6.76 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.7976 | No adjustment was made for multiple comparisons. | Adjusted Mean Difference | -1.2 | 2-Sided | 95 | -10.48 | 8.10 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.7575 | No adjustment was made for multiple comparisons. | Adjusted Mean Difference | -1.7 | 2-Sided | 95 | -12.63 | 9.25 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level. | ANCOVA | ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity | 0.6727 | No adjustment was made for multiple comparisons. | Adjusted Mean Difference | -2.3 | 2-Sided | 95 | -13.42 | 8.73 | Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. | No | Superiority or Other |