Dentinal HypersensitivityPhase 1NCT01587950

The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity

A Phase 1 study testing Potassium Nitrate in people with Dentinal Hypersensitivity and Dental Pain, 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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Dentinal Hypersensitivity, Dental Pain
What is being tested?: Potassium Nitrate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Feb 2009to Apr 2009
Phase: Phase 1
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

General Health and Oral Heath: Good general health and oral health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.
Teeth: Presence of teeth in various locations in the mouth to determine stent success. Required teeth include: at least three first molars; a maxillary incisor, cuspid and bicuspid; and a mandibular incisor, cuspid and bicuspid.
Dental Sensitivity: a) Self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth. b) A minimum of three accessible teeth that can be isolated that meet all of the following criteria at the screening visit: i. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. Study teeth must exhibit greater than or equal to 3mm recession at the facial surface midpoint. ii. Teeth must be visually stain and calculus free. iii. Teeth having a gingival index score less than or equal to 2. iv. Teeth with a clinical mobility of less than or equal to 1. v. Teeth that show signs of sensitivity, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm visual analogue scale (VAS). c) A minimum of three eligible teeth identified at the screening visit that continue to show signs of sensitivity at the baseline assessment at treatment visit 1, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm VAS.

Who cannot join

Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the stent materials (or closely related compounds) or any of their stated ingredients.
Condition of the Dentition: a) Sensitive teeth not expected to respond to treatment with an over-the-counter (OTC) 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 aetiologies other than erosion, abrasion or recession of exposed dentine.

Trial locations and contacts

1 site in 1 country.

United States1 site

University Park Research Center (UPRC)
Fort Wayne, Indiana, 46825

Other trials in United States

About this study

Official title: An Exploratory Study Investigating the Effects of a Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity

A randomized, controlled, double blind exploratory study to explore the effects of two different potassium nitrate concentrations and water on exposed dentine in reducing dentinal hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by visual analogue scale (VAS) scores following evaporative (air) stimulus.

Conditions: Dentinal Hypersensitivity, Dental Pain
Being tested: Potassium Nitrate, Placebo
Keywords: dentinal sensitivity, potassium nitrate, dental pain
Medical subject headings: Toothache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Potassium NitrateDrug
250 μL of Potassium nitrate solution (either 5% or 2.5%)
PlaceboDrug
Sterile Water

Study groups in NCT01587950
Study group	Role	What they receive
Sterile water	Placebo comparator	Participants to receive 250 microlitres (μL) of sterile water. Receives: Drug: Placebo
Potassium nitrate 5% solution	Experimental	Participants to receive 250 μL of potassium nitrate 5% solution. Receives: Drug: Potassium Nitrate
Potassium nitrate 2.5% solution	Experimental	Participants to receive 250 μL of potassium nitrate 2.5% solution. Receives: Drug: Potassium Nitrate

What is being measured

The primary outcome is the main question the study is designed to answer.

Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment.
Measured: Baseline, immediately post administration of treatment
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment.
Measured: Baseline, 10 minutes post administration of treatment
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment.
Measured: Baseline, 20 minutes post administration of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Apr 2009

First posted30 Apr 2012 (estimated)
Study startFeb 2009
Primary completionApr 2009
Study completionApr 2009

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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01587950
Sponsor's protocol ID: Z3770631
Status last verified: Mar 2013
First submitted: 17 Nov 2011
Last updated: 28 Apr 2015
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

RecruitingPhase 3
Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies
Dentinal Sensitivity, Dentinal Hypersensitivity
Not yet recruitingPhase 2/3
Gluma Compared With Bonding Agent for Post-operative Sensitivity Following Composite Restorations
Post-operative Sensitivity, Dentin Hypersensitivity
Not yet recruiting
Comparative Efficacy of Laser Systems and Fluoride in Managing Dentinal Hypersensitivity: RCT
Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity
Not yet recruiting
Comparison of LASER Therapy and Desensitizing Agents in Dentinal Hypersensitivity
Dentinal Hypersensitivity
Not yet recruiting
Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity
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All Dentinal Hypersensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Study Investigating the Effects of a Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity
ClinicalTrials.gov ID: NCT01587950
Acronym / sponsor ID: Z3770631
Conditions: Dentinal Hypersensitivity, Dental Pain
Keywords: dentinal sensitivity, potassium nitrate, dental pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 30 Apr 2012 (estimated)
Results: Posted 28 Apr 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Sterile water	Placebo comparator	Drug: PlaceboParticipants to receive 250 microlitres (μL) of sterile water.
Potassium nitrate 5% solution	Experimental	Drug: Potassium NitrateParticipants to receive 250 μL of potassium nitrate 5% solution.
Potassium nitrate 2.5% solution	Experimental	Drug: Potassium NitrateParticipants to receive 250 μL of potassium nitrate 2.5% solution.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

General Health and Oral Heath: Good general health and oral health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.
Teeth: Presence of teeth in various locations in the mouth to determine stent success. Required teeth include: at least three first molars; a maxillary incisor, cuspid and bicuspid; and a mandibular incisor, cuspid and bicuspid.
Dental Sensitivity: a) Self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth. b) A minimum of three accessible teeth that can be isolated that meet all of the following criteria at the screening visit: i. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion. Study teeth must exhibit greater than or equal to 3mm recession at the facial surface midpoint. ii. Teeth must be visually stain and calculus free. iii. Teeth having a gingival index score less than or equal to 2. iv. Teeth with a clinical mobility of less than or equal to 1. v. Teeth that show signs of sensitivity, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm visual analogue scale (VAS). c) A minimum of three eligible teeth identified at the screening visit that continue to show signs of sensitivity at the baseline assessment at treatment visit 1, evaporative (air) sensitive teeth displaying a response of greater than or equal to 30 mm on a 100 mm VAS.

Key exclusion criteria (2 listed)

Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the stent materials (or closely related compounds) or any of their stated ingredients.
Condition of the Dentition: a) Sensitive teeth not expected to respond to treatment with an over-the-counter (OTC) 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 aetiologies other than erosion, abrasion or recession of exposed dentine.

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
Potassium Nitrate250 μL of Potassium nitrate solution (either 5% or 2.5%)	Drug	Potassium nitrate 2.5% solution, Potassium nitrate 5% solution
PlaceboSterile Water	Drug	Sterile water

Primary outcome

Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Time frame: Baseline, immediately post administration of treatment
Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment.
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Time frame: Baseline, 10 minutes post administration of treatment
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment.
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Time frame: Baseline, 20 minutes post administration of treatment
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment.

Results and safety

Results posted to the registry on 28 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall	12	12

Primary outcome: Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water

Time frame: Baseline, immediately post administration of treatment. Mean (95% Confidence Interval). Unit: Units on a scale

Measure	2.5% KNO3 Solution (2 Minutes) n = 8	5% KNO3 Solution (2 Minutes) n = 10	Sterile Water (2 Minutes) n = 10	2.5% KNO3 Solution (5 Minutes) n = 7	5% KNO3 Solution (5 Minutes) n = 10	Sterile Water (5 Minutes) n = 10	2.5% KNO3 Solution (10 Minutes) n = 7	5% KNO3 Solution (10 Minutes) n = 10	Sterile Water (10 Minutes) n = 10
Value	-13.48 (-24.59 to -2.38)	-12.49 (-22.34 to -2.64)	-8.59 (-18.74 to 1.55)	-14.14 (-26.13 to -2.15)	-17.51 (-27.40 to -7.62)	-11.12 (-20.88 to -1.36)	-8.38 (-20.14 to 3.37)	-17.34 (-27.15 to -7.53)	-14.62 (-24.44 to -4.81)

2.5% KNO3 Solution (2 Minutes) vs 5% KNO3 Solution (2 Minutes): Adjusted Mean Difference: -0.99 (95% CI -15.50 to 13.52), p = 0.8918, ANCOVA
2.5% KNO3 Solution (2 Minutes) vs Sterile Water (2 Minutes): Adjusted Mean Difference: -4.89 (95% CI -19.91 to 10.14), p = 0.5183, ANCOVA
5% KNO3 Solution (2 Minutes) vs Sterile Water (2 Minutes): Adjusted Mean Difference: -3.89 (95% CI -17.59 to 9.80), p = 0.5718, ANCOVA

Population analysed: Intent to treat (ITT) population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to drop outs, there was difference in number of participant analyzed.

Primary outcome: Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water

Time frame: Baseline, 10 minutes post administration of treatment. Mean (95% Confidence Interval). Unit: Units on a scale

Measure	2.5% KNO3 Solution (2 Minutes) n = 8	5% KNO3 Solution (2 Minutes) n = 10	Sterile Water (2 Minutes) n = 10	2.5% KNO3 Solution (5 Minutes) n = 7	5% KNO3 Solution (5 Minutes) n = 10	Sterile Water (5 Minutes) n = 10	2.5% KNO3 Solution (10 Minutes) n = 7	5% KNO3 Solution (10 Minutes) n = 10	Sterile Water (10 Minutes) n = 10
Value	-20.23 (-31.58 to -8.88)	-13.84 (-23.92 to -3.76)	-9.01 (-19.39 to 1.38)	-22.67 (-34.92 to -10.42)	-12.80 (-22.92 to -2.67)	-11.55 (-21.55 to -1.55)	-9.80 (-21.83 to 2.23)	-20.81 (-30.88 to -10.74)	-15.25 (-25.31 to -5.19)

2.5% KNO3 Solution (2 Minutes) vs 5% KNO3 Solution (2 Minutes): Adjusted Mean Difference: -6.39 (95% CI -21.04 to 8.26), p = 0.3867, ANCOVA
2.5% KNO3 Solution (2 Minutes) vs Sterile Water (2 Minutes): Adjusted Mean Difference: -11.22 (95% CI -26.41 to 3.96), p = 0.1448, ANCOVA
5% KNO3 Solution (2 Minutes) vs Sterile Water (2 Minutes): Adjusted Mean Difference: -4.83 (95% CI -18.66 to 8.99), p = 0.4874, ANCOVA

Population analysed: ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group.

Primary outcome: Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water

Time frame: Baseline, 20 minutes post administration of treatment. Mean (95% Confidence Interval). Unit: Units on a scale

Measure	2.5% KNO3 Solution (2 Minutes) n = 8	5% KNO3 Solution (2 Minutes) n = 10	Sterile Water (2 Minutes) n = 10	2.5% KNO3 Solution (5 Minutes) n = 7	5% KNO3 Solution (5 Minutes) n = 10	Sterile Water (5 Minutes) n = 10	2.5% KNO3 Solution (10 Minutes) n = 7	5% KNO3 Solution (10 Minutes) n = 10	Sterile Water (10 Minutes) n = 10
Value	-22.54 (-33.96 to -11.12)	-20.58 (-30.88 to -10.29)	-16.22 (-26.78 to -5.67)	-22.25 (-34.52 to -9.98)	-16.57 (-26.88 to -6.26)	-18.23 (-28.46 to -8.00)	-12.21 (-24.38 to -0.05)	-19.97 (-30.33 to -9.61)	-18.90 (-29.21 to -8.59)

2.5% KNO3 Solution (2 Minutes) vs 5% KNO3 Solution (2 Minutes): Adjusted Mean Difference: -1.96 (95% CI -15.71 to 11.80), p = 0.7769, ANCOVA
2.5% KNO3 Solution (2 Minutes) vs Sterile Water (2 Minutes): Adjusted Mean Difference: -6.32 (95% CI -20.64 to 8.00), p = 0.3811, ANCOVA
5% KNO3 Solution (2 Minutes) vs Sterile Water (2 Minutes): Adjusted Mean Difference: -4.36 (95% CI -17.35 to 8.63), p = 0.5044, ANCOVA

Adverse events

Time frame: All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall	0 of 12 (0%)	0 of 12 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 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 1 study testing Potassium Nitrate in people with Dentinal Hypersensitivity and Dental Pain, 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 3 inclusion and 2 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 28 Apr 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 28 Apr 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?

Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water (time frame: Baseline, immediately post administration of treatment). The study lists 3 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 NCT01587950.

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 28 Apr 2015.