Dentinal HypersensitivityPhase 2NCT01831817
Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
A Phase 2 study testing 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice, 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice and Sodium monofluorophosphate dentifrice in people with Dentinal Hypersensitivity, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentinal Hypersensitivity
- What is being tested?
- 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice, 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice and Sodium monofluorophosphate dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study.
- Participants will be required to have at least four teeth with facial/cervical erosion, abrasion and/or gingival recession which respond to qualifying evaporative (air) assessment at the Screening visit and have at least two teeth (incisors, canines or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile threshold (Yeaple ≤ 20 gram (g)) and evaporative (air) (Schiff Sensitivity Score ≥ 2) assessments at the Baseline visit.
Who cannot join
- Specific Dentition Exclusions for Test teeth
- Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of Screening.
- Tooth with exposed dentin but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentin.
- Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
- Use of a sensitivity dentifrice within 8 weeks of screening
- Individuals who require antibiotic prophylaxis for dental procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity
The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.
Read the detailed description
This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arms, parallel design study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at baseline, four and eight weeks to monitor clinical efficacy and safety.
- Conditions
- Dentinal Hypersensitivity
- Being tested
- 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice, 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice, Sodium monofluorophosphate dentifrice, Sodium Fluoride dentifrice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifriceDrug
Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate
0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifriceDrug
No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate
Sodium monofluorophosphate dentifriceDrug
Sodium monofluorophospate dentifrice (1000 ppm F)
Sodium Fluoride dentifriceDrug
Dentifrice containing 1100ppm F as sodium fluoride
| Study group | Role | What they receive |
|---|---|---|
| 5% calcium sodium phosphosilicate/ sodium monofluorophosphate | Experimental | Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate Receives: Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice |
| 0% calcium sodium phosphosilicate/sodium monofluorophosphate | Active comparator | Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate Receives: Drug: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice |
| Sodium monofluorophosphate | Active comparator | Dentifrice containing 1000 ppmF as sodium monofluorophosphate Receives: Drug: Sodium monofluorophosphate dentifrice |
| Sodium fluoride | Active comparator | Dentifrice containing 1100 ppmF as sodium fluoride Receives: Drug: Sodium Fluoride dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Schiff Sensitivity Score at Week 4
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 did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
Measured: Baseline and 4 weeks post administration of study treatment
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
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 did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
Measured: Baseline and 8 weeks post administration of study treatment
Median Change From Baseline in Tactile Sensitivity at Week 4
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Measured: Baseline and 4 weeks post administration of study treatment
Median Change From Baseline in Tactile Sensitivity at Week 8
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Measured: Baseline and 8 weeks post administration of study treatment
Mean Change From Baseline in Visual Rating Scale Score at Week 4
The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".
Measured: Baseline and 4 weeks post administration of study treatment
Mean Change From Baseline in Visual Rating Scale Score at Week 8
The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".
Measured: Baseline and 8 weeks post administration of study treatment
Secondary outcomes (2)
Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4
DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.
Measured: Baseline and 4 weeks post administration of study treatment
Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8
DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.
Measured: Baseline and 8 weeks post administration of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dentinal HypersensitivityStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831817
- Sponsor's protocol ID
- RH01591
- Status last verified
- Feb 2015
- First submitted
- 11 Apr 2013
- Last updated
- 26 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in the Relief of Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT01831817
- Acronym / sponsor ID
- RH01591
- Conditions
- Dentinal Hypersensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Posted 26 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.
Detailed description
This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arms, parallel design study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at baseline, four and eight weeks to monitor clinical efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5% calcium sodium phosphosilicate/ sodium monofluorophosphate | Experimental | Drug: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifriceDentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate |
| 0% calcium sodium phosphosilicate/sodium monofluorophosphate | Active comparator | Drug: 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifriceDentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate |
| Sodium monofluorophosphate | Active comparator | Drug: Sodium monofluorophosphate dentifriceDentifrice containing 1000 ppmF as sodium monofluorophosphate |
| Sodium fluoride | Active comparator | Drug: Sodium Fluoride dentifriceDentifrice containing 1100 ppmF as sodium fluoride |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study.
- Participants will be required to have at least four teeth with facial/cervical erosion, abrasion and/or gingival recession which respond to qualifying evaporative (air) assessment at the Screening visit and have at least two teeth (incisors, canines or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile threshold (Yeaple ≤ 20 gram (g)) and evaporative (air) (Schiff Sensitivity Score ≥ 2) assessments at the Baseline visit.
Key exclusion criteria (6 listed)
- Specific Dentition Exclusions for Test teeth
- Use of a sensitivity dentifrice within 8 weeks of screening
- Individuals who require antibiotic prophylaxis for dental procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifriceCalcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate | Drug | 5% calcium sodium phosphosilicate/ sodium monofluorophosphate |
| 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifriceNo calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate | Drug | 0% calcium sodium phosphosilicate/sodium monofluorophosphate |
| Sodium monofluorophosphate dentifriceSodium monofluorophospate dentifrice (1000 ppm F) | Drug | Sodium monofluorophosphate |
| Sodium Fluoride dentifriceDentifrice containing 1100ppm F as sodium fluoride | Drug | Sodium fluoride |
Primary outcome
Mean Change From Baseline in Schiff Sensitivity Score at Week 4
Time frame: Baseline and 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 did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
Time frame: Baseline and 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 did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
Median Change From Baseline in Tactile Sensitivity at Week 4
Time frame: Baseline and 4 weeks post administration of study treatment
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Median Change From Baseline in Tactile Sensitivity at Week 8
Time frame: Baseline and 8 weeks post administration of study treatment
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Mean Change From Baseline in Visual Rating Scale Score at Week 4
Time frame: Baseline and 4 weeks post administration of study treatment
The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".
Mean Change From Baseline in Visual Rating Scale Score at Week 8
Time frame: Baseline and 8 weeks post administration of study treatment
The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".
2 secondary outcomes
Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4
Time frame: Baseline and 4 weeks post administration of study treatment
Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8
Time frame: Baseline and 8 weeks post administration of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice, 0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice and Sodium monofluorophosphate dentifrice in people with Dentinal Hypersensitivity, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Schiff Sensitivity Score at Week 4 (time frame: Baseline and 4 weeks post administration of study treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.