Trial · NCT01592864
The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity
NCT01592864, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-03-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity. Trials, record NCT01592864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01592864
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity
- NCT number
- NCT01592864
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 120 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Dentine Hypersensitivity
- Interventions
- Stannous Fluoride, Sodium Monofluorophosphate
- First posted
- 2012-05-07
- Last updated
- 2014-03-10
- Results first posted
- 2014-03-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a 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 is 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. |
| Secondary | Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a 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. |
| Secondary | Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response 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. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated. sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. |
| Secondary | Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response 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. The constant pressure 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 subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated |
Source ClinicalTrials.gov
Outcomes4
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 Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8 | Baseline to 8 weeks post administration of study treatment | Intent to Treat (ITT) Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4 | Baseline to 4 weeks post administration of study treatment | ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed. | Score on a scale | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8 | Baseline to 8 weeks post administration of study treatment | ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed. | grams | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4 | Baseline to 4 weeks post administration of study treatment | ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed. | grams | MEAN |
Source ClinicalTrials.gov
Results by group8
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 Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8 | SnF Dentifrice | -0.9 | Standard Deviation 0.68 | Score on a scale | |
| Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8 | NaMFP Dentifrice | -0.5 | Standard Deviation 0.44 | Score on a scale | |
| Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4 | SnF Dentifrice | -0.7 | Standard Deviation 0.58 | Score on a scale | |
| Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4 | NaMFP Dentifrice | -0.2 | Standard Deviation 0.43 | Score on a scale | |
| Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8 | SnF Dentifrice | 21.3 | Standard Deviation 21.80 | grams | |
| Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8 | NaMFP Dentifrice | 4.2 | Standard Deviation 6.18 | grams | |
| Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4 | SnF Dentifrice | 11.2 | Standard Deviation 15.95 | grams | |
| Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4 | NaMFP Dentifrice | 1.5 | Standard Deviation 3.86 | grams |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stannous Fluoride (SnF) Dentifrice | 60 | |
| Overall Study | STARTED | Sodium Monofluorophosphate (NaMFP) Dentifrice | 58 | |
| Overall Study | COMPLETED | Stannous Fluoride (SnF) Dentifrice | 60 | |
| Overall Study | COMPLETED | Sodium Monofluorophosphate (NaMFP) Dentifrice | 57 | |
| Overall Study | NOT COMPLETED | Stannous Fluoride (SnF) Dentifrice | 0 | |
| Overall Study | NOT COMPLETED | Sodium Monofluorophosphate (NaMFP) Dentifrice | 1 |
Source ClinicalTrials.gov
Adverse events4
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 | Oral Herpes | Infections and infestations | SnF Dentifrice | 1 | 60 | 1 |
| other | Oral Herpes | Infections and infestations | NaMFP Dentifrice | 0 | 58 | 0 |
| serious | Cholecystitis | Hepatobiliary disorders | SnF Dentifrice | 0 | 60 | 0 |
| serious | Cholecystitis | Hepatobiliary disorders | NaMFP Dentifrice | 1 | 58 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SnF Dentifrice | ||
| Total, all-cause mortality | NaMFP Dentifrice | ||
| Total, other adverse events | SnF Dentifrice | 1 | 60 |
| Total, other adverse events | NaMFP Dentifrice | 0 | 58 |
| Total, serious adverse events | SnF Dentifrice | 0 | 60 |
| Total, serious adverse events | NaMFP Dentifrice | 1 | 58 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| SnF Dentifrice vs NaMFP Dentifrice: 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.
GET https://conductscience.org/api/trials/v1/NCT01592864
GET https://conductscience.org/api/trials/v1/NCT01592864/registered