Trial · NCT01691560
Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
NCT01691560, Phase 2, Completed, GlaxoSmithKline; results first posted 2014-05-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity. Trials, record NCT01691560. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01691560
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
- NCT number
- NCT01691560
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 140 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Dentine Hypersensitivity
- Interventions
5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice, 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice, Sodium monofluorophosphate dentifrice, Sodium fluoride dentifrice
- First posted
- 2012-09-24
- Last updated
- 2014-05-29
- Results first posted
- 2014-05-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 | Baseline to 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 does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. |
| Primary | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | Baseline to 4 weeks post administration of study treatment | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached. |
| Primary | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8 | Baseline to 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 does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. |
| Primary | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8 | Baseline to 8 weeks post administration of study treatment | Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached. |
| Primary | Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4 | Baseline to 4 weeks post administration of study treatment | Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain). |
| Primary | Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8 | Baseline to 8 weeks post administration of study treatment | Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 | Baseline to 4 weeks post administration of study treatment | Intent to Treat (ITT) population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy. | Score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | Baseline to 4 weeks post administration of study treatment | ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy. | grams | MEAN |
| PRIMARY | Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8 | Baseline to 8 weeks post administration of study treatment | ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy. | Score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8 | Baseline to 8 weeks post administration of study treatment | ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy. | grams | MEAN |
| PRIMARY | Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4 | Baseline to 4 weeks post administration of study treatment | ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy. | Score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8 | Baseline to 8 weeks post administration of study treatment | ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy. | Score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | -0.36 | 95% Confidence Interval -0.53 to -0.20 | Score on a scale | |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 | Sodium Monofluorophosphate | -0.43 | 95% Confidence Interval -0.59 to -0.27 | Score on a scale | |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 | Sodium Fluoride | -0.40 | 95% Confidence Interval -0.57 to -0.23 | Score on a scale | |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | -0.45 | 95% Confidence Interval -0.62 to -0.28 | Score on a scale | |
| Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 7.31 | Standard Deviation 11.227 | grams | |
| Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | Sodium Monofluorophosphate | 6.32 | Standard Deviation 13.045 | grams | |
| Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | Sodium Fluoride | 4.09 | Standard Deviation 4.752 | grams | |
| Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4 | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 3.64 | Standard Deviation 6.030 | grams | |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8 | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | -0.55 | 95% Confidence Interval -0.78 to -0.33 | Score on a scale | |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8 | Sodium Monofluorophosphate | -0.43 | 95% Confidence Interval -0.66 to -0.20 | Score on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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 | 34 | |
| Overall Study | STARTED | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 33 | |
| Overall Study | STARTED | Sodium Monofluorophosphate | 34 | |
| Overall Study | STARTED | Sodium Fluoride | 33 | |
| Overall Study | COMPLETED | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 34 | |
| Overall Study | COMPLETED | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 33 | |
| Overall Study | COMPLETED | Sodium Monofluorophosphate | 34 | |
| Overall Study | COMPLETED | Sodium Fluoride | 33 | |
| Overall Study | NOT COMPLETED | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 0 | |
| Overall Study | NOT COMPLETED | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse 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 | 0 | 34 |
| Total, other adverse events | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 0 | 33 |
| Total, other adverse events | Sodium Monofluorophosphate | 0 | 34 |
| Total, other adverse events | Sodium Fluoride | 0 | 33 |
| Total, serious adverse events | 5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 0 | 34 |
| Total, serious adverse events | 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate | 0 | 33 |
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/NCT01691560
GET https://conductscience.org/api/trials/v1/NCT01691560/results?page=2