Trial · NCT01831817
Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
NCT01831817, Phase 2, Completed, GlaxoSmithKline; results first posted 2015-03-26
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity. Trials, record NCT01831817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01831817
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
- NCT number
- NCT01831817
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 140 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Dentinal Hypersensitivity
- Interventions
5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice, 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice, Sodium monofluorophosphate dentifrice, Sodium Fluoride dentifrice
- First posted
- 2013-04-15
- Last updated
- 2015-03-26
- Results first posted
- 2015-03-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Baseline and 4 weeks post administration of study treatment | Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus. |
| Primary | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Baseline and 8 weeks post administration of study treatment | Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus. |
| Primary | Median Change From Baseline in Tactile Sensitivity at Week 4 | Baseline and 4 weeks post administration of study treatment | 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 subject whether the sensation caused discomfort. The pressure setting at which the subject 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. |
| Primary | Median Change From Baseline in Tactile Sensitivity at Week 8 | Baseline and 8 weeks post administration of study treatment | 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 subject whether the sensation caused discomfort. The pressure setting at which the subject 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. |
| Primary | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Baseline and 4 weeks post administration of study treatment | The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain". |
| Primary | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Baseline and 8 weeks post administration of study treatment | The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain". |
| Secondary | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | Baseline and 4 weeks post administration of study treatment | DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life. |
| Secondary | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | Baseline and 8 weeks post administration of study treatment | DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Baseline and 4 weeks post administration of study treatment | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Score on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Schiff Sensitivity Score at Week 8 | Baseline and 8 weeks post administration of study treatment | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Score on a Scale | MEAN |
| PRIMARY | Median Change From Baseline in Tactile Sensitivity at Week 4 | Baseline and 4 weeks post administration of study treatment | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | grams | MEDIAN |
| PRIMARY | Median Change From Baseline in Tactile Sensitivity at Week 8 | Baseline and 8 weeks post administration of study treatment | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | grams | MEDIAN |
| PRIMARY | Mean Change From Baseline in Visual Rating Scale Score at Week 4 | Baseline and 4 weeks post administration of study treatment | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Score on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Visual Rating Scale Score at Week 8 | Baseline and 8 weeks post administration of study treatment | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4 | Baseline and 4 weeks post administration of study treatment | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8 | Baseline and 8 weeks post administration of study treatment | The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy. | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Baseline | 2.39 | Standard Deviation 0.396 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Baseline | 2.41 | Standard Deviation 0.435 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Sodium Monofluorophosphate | Baseline | 2.40 | Standard Deviation 0.417 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Sodium Fluoride | Baseline | 2.38 | Standard Deviation 0.403 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Week 4 | 1.83 | Standard Deviation 0.779 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Week 4 | 1.94 | Standard Deviation 0.547 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Sodium Monofluorophosphate | Week 4 | 2.31 | Standard Deviation 0.516 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | Sodium Fluoride | Week 4 | 2.31 | Standard Deviation 0.401 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | Mean change from baseline at Week 4 | -0.56 | Standard Deviation 0.759 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score at Week 4 | 0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate | Mean change from baseline at Week 4 | -0.47 | Standard Deviation 0.563 | Score on a scale |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 35 | |
| Overall Study | STARTED | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 34 | |
| Overall Study | STARTED | Sodium Monofluorophosphate | 35 | |
| Overall Study | STARTED | Sodium Fluoride | 36 | |
| Overall Study | COMPLETED | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 31 | |
| Overall Study | COMPLETED | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 34 | |
| Overall Study | COMPLETED | Sodium Monofluorophosphate | 35 | |
| Overall Study | COMPLETED | Sodium Fluoride | 36 | |
| Overall Study | NOT COMPLETED | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 4 | |
| Overall Study | NOT COMPLETED | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 1 | 35 | 2 |
| other | Headache | Nervous system disorders | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 2 | 34 | 2 |
| other | Headache | Nervous system disorders | Sodium Monofluorophosphate | 1 | 35 | 1 |
| other | Headache | Nervous system disorders | Sodium Fluoride | 2 | 36 | 2 |
| other | Arthralgia | Immune system disorders | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 1 | 35 | 1 |
| other | Arthralgia | Immune system disorders | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 0 | 34 | 0 |
| other | Arthralgia | Immune system disorders | Sodium Monofluorophosphate | 0 | 35 | 0 |
| other | Arthralgia | Immune system disorders | Sodium Fluoride | 0 | 36 | 0 |
| other | Constipation | Gastrointestinal disorders | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 1 | 35 | 1 |
| other | Constipation | Gastrointestinal disorders | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 0 | 34 | 0 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | ||
| Total, all-cause mortality | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | ||
| Total, all-cause mortality | Sodium Monofluorophosphate | ||
| Total, all-cause mortality | Sodium Fluoride | ||
| Total, other adverse events | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 5 | 35 |
| Total, other adverse events | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 3 | 34 |
| Total, other adverse events | Sodium Monofluorophosphate | 2 | 35 |
| Total, other adverse events | Sodium Fluoride | 2 | 36 |
| Total, serious adverse events | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 0 | 35 |
| Total, serious adverse events | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 0 | 34 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01831817
GET https://conductscience.org/api/trials/v1/NCT01831817/results?page=2