Trial · NCT03072719
The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity
NCT03072719, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity. Trials, record NCT03072719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03072719
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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 Immediate and Short Term Relief From Dentinal Hypersensitivity
- NCT number
- NCT03072719
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 120 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Dentine Hypersensitivity
- Interventions
- Stannous Fluoride, Sodium Monofluorophosphate
- First posted
- 2017-03-07
- Last updated
- 2018-03-06
- Results first posted
- 2017-04-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Schiff Sensitivity Score on Day 14 | Baseline, Day 14 | Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity. |
| Secondary | Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | Baseline, post first brushing (after 5 minutes) and Day 3 | Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. |
| Secondary | Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 | Baseline, post first brushing (after 5 minutes), Day 3 and Day 14 | Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. |
Source ClinicalTrials.gov
Outcomes3
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 Schiff Sensitivity Score on Day 14 | Baseline, Day 14 | Analysis for this outcome was conducted on intent-to-treat (ITT) population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time point for treatment arms respectively. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | Baseline, post first brushing (after 5 minutes) and Day 3 | Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 | Baseline, post first brushing (after 5 minutes), Day 3 and Day 14 | Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively. | gram (g) | MEAN |
Source ClinicalTrials.gov
Results by group28
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 Schiff Sensitivity Score on Day 14 | Experimental Dentifrice | At Baseline | 2.51 | Standard Deviation 0.437 | score on a scale |
| Change From Baseline in Schiff Sensitivity Score on Day 14 | Reference Dentifrice | At Baseline | 2.51 | Standard Deviation 0.446 | score on a scale |
| Change From Baseline in Schiff Sensitivity Score on Day 14 | Experimental Dentifrice | At Day 14 | 1.16 | Standard Deviation 0.774 | score on a scale |
| Change From Baseline in Schiff Sensitivity Score on Day 14 | Reference Dentifrice | At Day 14 | 1.35 | Standard Deviation 0.901 | score on a scale |
| Change From Baseline in Schiff Sensitivity Score on Day 14 | Experimental Dentifrice | Change from Baseline on Day 14 | -1.35 | Standard Deviation 0.727 | score on a scale |
| Change From Baseline in Schiff Sensitivity Score on Day 14 | Reference Dentifrice | Change from Baseline on Day 14 | -1.16 | Standard Deviation 0.762 | score on a scale |
| Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | Experimental Dentifrice | After 5 minutes of brushing | 1.73 | Standard Deviation 0.826 | score on a scale |
| Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | Reference Dentifrice | After 5 minutes of brushing | 1.92 | Standard Deviation 0.737 | score on a scale |
| Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | Experimental Dentifrice | Change after 5 minutes of brushing | -0.78 | Standard Deviation 0.660 | score on a scale |
| Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 | Reference Dentifrice | Change after 5 minutes of brushing | -0.59 | Standard Deviation 0.571 | score on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental Dentifrice | 60 | |
| Overall Study | STARTED | Reference Dentifrice | 60 | |
| Overall Study | COMPLETED | Experimental Dentifrice | 59 | |
| Overall Study | COMPLETED | Reference Dentifrice | 59 | |
| Overall Study | NOT COMPLETED | Experimental Dentifrice | 1 | |
| Overall Study | NOT COMPLETED | Reference Dentifrice | 1 |
Source ClinicalTrials.gov
Adverse events30
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 | Sensitivity of Teeth | Gastrointestinal disorders | Experimental Dentifrice | 5 | 60 | |
| other | Sensitivity of Teeth | Gastrointestinal disorders | Reference Dentifrice | 0 | 60 | |
| other | Dry Mouth | Gastrointestinal disorders | Experimental Dentifrice | 0 | 60 | |
| other | Dry Mouth | Gastrointestinal disorders | Reference Dentifrice | 2 | 60 | |
| other | Gingival Bleeding | Gastrointestinal disorders | Experimental Dentifrice | 0 | 60 | |
| other | Gingival Bleeding | Gastrointestinal disorders | Reference Dentifrice | 1 | 60 | |
| other | Gingivitis | Gastrointestinal disorders | Experimental Dentifrice | 1 | 60 | |
| other | Gingivitis | Gastrointestinal disorders | Reference Dentifrice | 0 | 60 | |
| other | Mouth Ulceration | Gastrointestinal disorders | Experimental Dentifrice | 0 | 60 | |
| other | Mouth Ulceration | Gastrointestinal disorders | Reference Dentifrice | 1 | 60 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental Dentifrice | 0 | 60 |
| Total, all-cause mortality | Reference Dentifrice | 0 | 60 |
| Total, other adverse events | Experimental Dentifrice | 9 | 60 |
| Total, other adverse events | Reference Dentifrice | 8 | 60 |
| Total, serious adverse events | Experimental Dentifrice | 0 | 60 |
| Total, serious adverse events | Reference Dentifrice | 0 | 60 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental Dentifrice vs Reference Dentifrice: deaths from any cause | Trial comparisons |
| Experimental Dentifrice vs Reference Dentifrice: serious adverse events | 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/NCT03072719
GET https://conductscience.org/api/trials/v1/NCT03072719/results?page=2