Trial · NCT01827670
Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
NCT01827670, Phase 3, Completed, GlaxoSmithKline; results first posted 2015-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity. Trials, record NCT01827670. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01827670
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
- NCT number
- NCT01827670
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 119 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Dentine Hypersensitivity
- Interventions
- Stannous fluoride, Sodium monofluorophosphate
- First posted
- 2013-04-09
- Last updated
- 2015-01-26
- Results first posted
- 2015-01-26
Source ClinicalTrials.gov
Registered outcomes6
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 | Baseline-Week 8 | The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation |
| Secondary | Mean Change From Baseline in Schiff Sensitivity Score | Baseline-Week 4 | The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation |
| Secondary | Mean Change From Baseline in Tactile Sensitivity | Baseline-Week 8 | The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached. |
| Secondary | Mean Change From Baseline in Tactile Sensitivity | Baseline-Week 4 | The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached. |
| Secondary | Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS) | Baseline-Week 4 | The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF |
| Secondary | Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS) | Baseline - Week 8 | The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF |
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 | Mean Change From Baseline in Schiff Sensitivity Score | Baseline-Week 8 | Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2 | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Schiff Sensitivity Score | Baseline-Week 4 | Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2 | Score on a Scale | MEAN |
| SECONDARY | Mean Change From Baseline in Tactile Sensitivity | Baseline-Week 8 | Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2 | Grams | MEAN |
| SECONDARY | Mean Change From Baseline in Tactile Sensitivity | Baseline-Week 4 | Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2 | Grams | MEAN |
| SECONDARY | Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS) | Baseline-Week 4 | Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2 | Score on a Scale | MEAN |
| SECONDARY | Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS) | Baseline - Week 8 | Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2 | Score on a Scale | 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 |
|---|---|---|---|---|---|
| Mean Change From Baseline in Schiff Sensitivity Score | Control Dentrifice (0.76% Sodium Monofluorophosphate) | Schiff Sensitivity Score at Baseline | 2.26 | Standard Deviation 0.379 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score | Test Dentrifice (0.454% Stannous Fluoride) | Schiff Sensitivity Score at Baseline | 2.25 | Standard Deviation 0.355 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score | Control Dentrifice (0.76% Sodium Monofluorophosphate) | Schiff Sensitivity Score at Week 8 | 2.09 | Standard Deviation 0.628 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score | Test Dentrifice (0.454% Stannous Fluoride) | Schiff Sensitivity Score at Week 8 | 0.78 | Standard Deviation 0.687 | Score on a scale |
| Mean Change From Baseline in Schiff Sensitivity Score | Control Dentrifice (0.76% Sodium Monofluorophosphate) | Schiff Sensitivity Score at Baseline | 2.26 | Standard Deviation 0.379 | Score on a Scale |
| Mean Change From Baseline in Schiff Sensitivity Score | Test Dentrifice (0.454% Stannous Fluoride) | Schiff Sensitivity Score at Baseline | 2.25 | Standard Deviation 0.355 | Score on a Scale |
| Mean Change From Baseline in Schiff Sensitivity Score | Control Dentrifice (0.76% Sodium Monofluorophosphate) | Schiff Sensitivity Score at Week 4 | 2.10 | Standard Deviation 0.601 | Score on a Scale |
| Mean Change From Baseline in Schiff Sensitivity Score | Test Dentrifice (0.454% Stannous Fluoride) | Schiff Sensitivity Score at Week 4 | 1.27 | Standard Deviation 0.598 | Score on a Scale |
| Mean Change From Baseline in Tactile Sensitivity | Control Dentrifice (0.76% Sodium Monofluorophosphate) | Tactile Threshold at Baseline (g) | 10.1 | Standard Deviation 0.66 | Grams |
| Mean Change From Baseline in Tactile Sensitivity | Test Dentrifice (0.454% Stannous Fluoride) | Tactile Threshold at Baseline (g) | 10.4 | Standard Deviation 1.43 | Grams |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Dentifrice (0.76% Sodium Monofluorophosphate) | 60 | |
| Overall Study | STARTED | Test Dentifrice (0.454% Stannous Fluoride) | 59 | |
| Overall Study | COMPLETED | Control Dentifrice (0.76% Sodium Monofluorophosphate) | 57 | |
| Overall Study | COMPLETED | Test Dentifrice (0.454% Stannous Fluoride) | 56 | |
| Overall Study | NOT COMPLETED | Control Dentifrice (0.76% Sodium Monofluorophosphate) | 3 | |
| Overall Study | NOT COMPLETED | Test Dentifrice (0.454% Stannous Fluoride) | 3 |
Source ClinicalTrials.gov
Adverse events6
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 | Dysgeusia | General disorders | Control Dentifrice (0.76% Sodium Monofluorophosphate) | 0 | 60 | 0 |
| other | Dysgeusia | General disorders | Test Dentifrice (0.454% Stannous Fluoride) | 1 | 59 | 1 |
| other | Mouth Injury | General disorders | Control Dentifrice (0.76% Sodium Monofluorophosphate) | 1 | 60 | 1 |
| other | Mouth Injury | General disorders | Test Dentifrice (0.454% Stannous Fluoride) | 0 | 59 | 0 |
| other | Influenza | Respiratory, thoracic and mediastinal disorders | Control Dentifrice (0.76% Sodium Monofluorophosphate) | 1 | 60 | 1 |
| other | Influenza | Respiratory, thoracic and mediastinal disorders | Test Dentifrice (0.454% Stannous Fluoride) | 0 | 59 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control Dentifrice (0.76% Sodium Monofluorophosphate) | ||
| Total, all-cause mortality | Test Dentifrice (0.454% Stannous Fluoride) | ||
| Total, other adverse events | Control Dentifrice (0.76% Sodium Monofluorophosphate) | 2 | 60 |
| Total, other adverse events | Test Dentifrice (0.454% Stannous Fluoride) | 1 | 59 |
| Total, serious adverse events | Control Dentifrice (0.76% Sodium Monofluorophosphate) | 0 | 60 |
| Total, serious adverse events | Test Dentifrice (0.454% Stannous Fluoride) | 0 | 59 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26437498 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Test Dentifrice (0.454% Stannous Fluoride) vs Control Dentifrice (0.76% Sodium Monofluorophosphate): serious adverse events |
Source Trial comparisons
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.
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