Dentine HypersensitivityPhase 2NCT01691560

Exploratory Study to Evaluate 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 Dentine Hypersensitivity, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 years
Conditions the study is for: Dentine 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: Aug 2012to Nov 2012
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
No healthy volunteers
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

Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
Breast-feeding: Women who are breast-feeding.
Medical History: a) Chronic debilitating disease is present b) Chronic disease or other condition is present that is associated with intermittent episodes or constant daily pain, such as arthritis, low back pain, dysmenorrhea, etc.
Medications: Daily doses of medication, which in the opinion of the investigator, might interfere with the perception of pain, are being taken. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory drugs.
Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an over-the- counter dentifrice in the opinion of the investigator. b) Teeth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns, orthodontic bands, extensive caries or cracked enamel. Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentine. c) Dental professional hygiene (includes dental prophylaxis, irrigation, and intensive anti-microbial/anti-biotic therapy) within 14 days of the screening visit. d) Presence of dental implants. e) Lip or tongue piercings. f) Periodontal surgical history within the past 6 months or have been scaled /root planed within the past 3 months.
Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit b) Previous participation in this study.
Other: Any subject who in the opinion of the investigator, should not participate in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

BioSci Research America
Las Vegas, Nevada, 89121-5466

Other trials in United States

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

Read the detailed description

This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth), exploratory 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: Dentine Hypersensitivity
Being tested: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice, 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice, Sodium monofluorophosphate dentifrice, Sodium fluoride dentifrice
Medical subject headings: Dentin Sensitivity

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
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifriceDrug
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
Sodium monofluorophosphate dentifriceDrug
Dentifrice containing 1000 ppmF as sodium monofluorophosphate
Sodium fluoride dentifriceDrug
Dentifrice containing 1100 ppmF as sodium fluoride

Study groups in NCT01691560
Study group	Role	What they receive
5% calcium sodium phosphosilicate/sodium monofluorophosphate	Experimental	Dentifrice containing 5.0% w/w calcium sodium phosphosilicate with sodium monofluorophosphate containing 1500 parts per million fluoride (ppmF). 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.

Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale 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 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.
Measured: Baseline to 4 weeks post administration of study treatment
Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
Measured: Baseline to 4 weeks post administration of study treatment
Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale 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 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.
Measured: Baseline to 8 weeks post administration of study treatment
Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
Measured: Baseline to 8 weeks post administration of study treatment
Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4
Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).
Measured: Baseline to 4 weeks post administration of study treatment
Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8
Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).
Measured: Baseline to 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.

Aug 2012Nov 2012

First posted24 Sep 2012 (estimated)
Study startAug 2012
Primary completionNov 2012
Study completionNov 2012

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 Dentine 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01691560
Sponsor's protocol ID: RH01426
Status last verified: Jul 2013
First submitted: 20 Sep 2012
Last updated: 29 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruiting
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Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
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Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
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All Dentine Hypersensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2014. 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: NCT01691560
Acronym / sponsor ID: RH01426
Conditions: Dentine Hypersensitivity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: BioSci Research
Study start: Aug 2012
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 24 Sep 2012 (estimated)
Results: Posted 29 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, 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 with sodium monofluorophosphate containing 1500 parts per million fluoride (ppmF).
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: Not 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 (8 listed)

Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
Breast-feeding: Women who are breast-feeding.
Medical History: a) Chronic debilitating disease is present b) Chronic disease or other condition is present that is associated with intermittent episodes or constant daily pain, such as arthritis, low back pain, dysmenorrhea, etc.
Medications: Daily doses of medication, which in the opinion of the investigator, might interfere with the perception of pain, are being taken. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, mood-altering and anti-inflammatory drugs.
Dentition Exclusions: a) Sensitive teeth not expected to respond to treatment with an over-the- counter dentifrice in the opinion of the investigator. b) Teeth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns, orthodontic bands, extensive caries or cracked enamel. Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentine. c) Dental professional hygiene (includes dental prophylaxis, irrigation, and intensive anti-microbial/anti-biotic therapy) within 14 days of the screening visit. d) Presence of dental implants. e) Lip or tongue piercings. f) Periodontal surgical history within the past 6 months or have been scaled /root planed within the past 3 months.

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 dentifriceDentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate	Drug	5% calcium sodium phosphosilicate/sodium monofluorophosphate
0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifriceDentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate	Drug	0% calcium sodium phosphosilicate/sodium monofluorophosphate
Sodium monofluorophosphate dentifriceDentifrice containing 1000 ppmF as sodium monofluorophosphate	Drug	Sodium monofluorophosphate
Sodium fluoride dentifriceDentifrice containing 1100 ppmF as sodium fluoride	Drug	Sodium fluoride

Primary outcome

Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4
Time frame: 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.
Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4
Time frame: 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. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8
Time frame: Baseline to 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 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.
Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8
Time frame: 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. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.
Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4
Time frame: Baseline to 4 weeks post administration of study treatment
Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).
Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8
Time frame: Baseline to 8 weeks post administration of study treatment
Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).

Results and safety

Results posted to the registry on 29 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate	34	34
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate	33	33
Sodium Monofluorophosphate	34	34
Sodium Fluoride	33	33

Primary outcome: Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4

Time frame: Baseline to 4 weeks post administration of study treatment. Least squares mean (95% Confidence Interval). Unit: Score on a scale

Measure	5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate n = 34	Sodium Monofluorophosphate n = 34	Sodium Fluoride n = 33	0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate n = 33
Value	-0.36 (-0.53 to -0.20)	-0.43 (-0.59 to -0.27)	-0.40 (-0.57 to -0.23)	-0.45 (-0.62 to -0.28)

5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate: Adjusted Mean Difference: 0.09 (95% CI -0.14 to 0.32), p = 0.4553, ANCOVA
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs Sodium Monofluorophosphate: Adjusted mean difference: 0.07 (95% CI -0.16 to 0.30), p = 0.5689, ANCOVA
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs Sodium Fluoride: Adjusted Mean Difference: 0.04 (95% CI -0.20 to 0.27), p = 0.7517, ANCOVA

Population analysed: Intent to Treat (ITT) population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.

Primary outcome: Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4

Time frame: Baseline to 4 weeks post administration of study treatment. Mean (Standard Deviation). Unit: grams

Measure	5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate n = 34	Sodium Monofluorophosphate n = 34	Sodium Fluoride n = 33	0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate n = 33
Value	7.31 (11.227)	6.32 (13.045)	4.09 (4.752)	3.64 (6.030)

5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate: Median Difference (Final Values): 0 (95% CI 0 to 5), p = 0.0467, Wilcoxon (Mann-Whitney)
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs Sodium Monofluorophosphate: Median Difference (Final Values): 0 (95% CI 0 to 5), p = 0.1133, Wilcoxon (Mann-Whitney)
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs Sodium Fluoride: Median Difference (Final Values): 0 (95% CI 0 to 5), p = 0.2579, Wilcoxon (Mann-Whitney)

Population analysed: ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.

Primary outcome: Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8

Time frame: Baseline to 8 weeks post administration of study treatment. Least squares mean (95% Confidence Interval). Unit: Score on a scale

Measure	5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate n = 34	Sodium Monofluorophosphate n = 34	Sodium Fluoride n = 33	0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate n = 33
Value	-0.55 (-0.78 to -0.33)	-0.43 (-0.66 to -0.20)	-0.43 (-0.66 to -0.20)	-0.92 (-1.15 to -0.68)

5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate: Adjusted Mean Difference: 0.36 (95% CI 0.04 to 0.69), p = 0.0292, ANCOVA
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs Sodium Monofluorophosphate: Adjusted Mean Difference: -0.12 (95% CI -0.44 to 0.20), p = 0.4484, ANCOVA
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs Sodium Fluoride: Adjusted Mean Difference: -0.12 (95% CI -0.45 to 0.20), p = 0.4537, ANCOVA

Population analysed: ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.

Primary outcome: Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8

Time frame: Baseline to 8 weeks post administration of study treatment. Mean (Standard Deviation). Unit: grams

Measure	5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate n = 34	Sodium Monofluorophosphate n = 34	Sodium Fluoride n = 33	0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate n = 33
Value	10.15 (15.100)	5.88 (11.512)	4.39 (5.556)	11.97 (16.486)

5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs 0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate: Median Difference (Final Values): 0 (95% CI -5 to 5), p = 0.8861, Wilcoxon (Mann-Whitney)
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs Sodium Monofluorophosphate: Median Difference (Final Values): 0 (95% CI 0 to 5), p = 0.0641, Wilcoxon (Mann-Whitney)
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate vs Sodium Fluoride: Median Difference (Final Values): 0 (95% CI 0 to 5), p = 0.1831, Wilcoxon (Mann-Whitney)

Population analysed: ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.

Adverse events

Time frame: Adverse events were collected collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate	0 of 34 (0%)	0 of 34 (0%)	Not reported
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate	0 of 33 (0%)	0 of 33 (0%)	Not reported
Sodium Monofluorophosphate	0 of 34 (0%)	0 of 34 (0%)	Not reported
Sodium Fluoride	0 of 33 (0%)	0 of 33 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
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?

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 8 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 29 May 2014. 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 29 May 2014). 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?

Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4 (time frame: Baseline to 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?

On the ClinicalTrials.gov record for NCT01691560.

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 29 May 2014.