Trial · NCT01592851
Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity
NCT01592851, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity. Trials, record NCT01592851. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01592851
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity
- NCT number
- NCT01592851
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 113 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Dentine Hypersensitivity
- Interventions
- Stannous Fluoride, Sodium Monofluorophosphate
- First posted
- 2012-05-07
- Last updated
- 2014-06-03
- Results first posted
- 2014-06-03
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 a Schiff Sensitivity Scale at Day 14 | Baseline to Day 14 | 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. |
| Secondary | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment | Baseline to immediately post treatment administration | 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. |
| Secondary | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3 | Baseline to Day 3 | 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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline. |
| Secondary | Change From Baseline in Tactile Pain Threshold Score at Day 14 | Baseline to Day 14 | The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity |
| Secondary | Change From Baseline in Tactile Pain Threshold Score at Day 3 | Baseline to Day 3 | The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity. |
| Secondary | Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment | Baseline to immediately post treatment administration | The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity. |
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 a Schiff Sensitivity Scale at Day 14 | Baseline to Day 14 | 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. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment | Baseline to immediately post treatment administration | 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. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3 | Baseline to Day 3 | 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. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Tactile Pain Threshold Score at Day 14 | Baseline to Day 14 | 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. | Force (grams) | MEAN |
| SECONDARY | Change From Baseline in Tactile Pain Threshold Score at Day 3 | Baseline to Day 3 | 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. | Force (grams) | MEAN |
| SECONDARY | Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment | Baseline to immediately post treatment administration | 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. | Force (grams) | MEAN |
Source ClinicalTrials.gov
Results by group12
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 a Schiff Sensitivity Scale at Day 14 | SnF Dentifrice | -1.20 | Standard Deviation 0.70 | Score on a scale | |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14 | NaMFP Dentifrice | -0.37 | Standard Deviation 0.43 | Score on a scale | |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment | SnF Dentifrice | -0.40 | Standard Deviation 0.46 | Score on a scale | |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment | NaMFP Dentifrice | -0.14 | Standard Deviation 0.35 | Score on a scale | |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3 | SnF Dentifrice | -0.70 | Standard Deviation 0.60 | Score on a scale | |
| Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3 | NaMFP Dentifrice | -0.25 | Standard Deviation 0.39 | Score on a scale | |
| Change From Baseline in Tactile Pain Threshold Score at Day 14 | SnF Dentifrice | 22.9 | Standard Deviation 21.14 | Force (grams) | |
| Change From Baseline in Tactile Pain Threshold Score at Day 14 | NaMFP Dentifrice | 3.5 | Standard Deviation 5.67 | Force (grams) | |
| Change From Baseline in Tactile Pain Threshold Score at Day 3 | SnF Dentifrice | 9.8 | Standard Deviation 15.52 | Force (grams) | |
| Change From Baseline in Tactile Pain Threshold Score at Day 3 | NaMFP Dentifrice | 3.0 | Standard Deviation 4.90 | Force (grams) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant 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 | 56 | |
| Overall Study | STARTED | Sodium Monofluorophosphate (NaMFP) Dentifrice | 57 | |
| Overall Study | COMPLETED | Stannous Fluoride (SnF) Dentifrice | 56 | |
| 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 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
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 | 0 | 56 |
| Total, other adverse events | NaMFP Dentifrice | 0 | 57 |
| Total, serious adverse events | SnF Dentifrice | 0 | 56 |
| Total, serious adverse events | NaMFP Dentifrice | 0 | 57 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27093773 | 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 |
|---|
| 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/NCT01592851
GET https://conductscience.org/api/trials/v1/NCT01592851/registered