Dentine HypersensitivityPhase 4NCT01075256

Dose Response of a Tubule Occlusion Agent

A Phase 4 study testing 5% calcium sodium phosphosilicate toothpaste and 7.5% calcium sodium phosphosilicate toothpaste in people with Dentine 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

To evaluate the efficacy of two different concentrations of a tubule occlusion agent - calcium sodium phosphosilicate in treatment of dentine hypersensitivity Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Dentine Hypersensitivity, Dental Pain
What is being tested?: 5% calcium sodium phosphosilicate toothpaste and 7.5% calcium sodium phosphosilicate toothpaste
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 195 participants
Where: 1 siteUnited States
Study dates: Dec 2008to Mar 2009
Phase: Phase 4
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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Age: Aged between 20 - 50 years.
General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.
Contraception: Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
Erosion/Abrasion/Recession:Study teeth must show signs of facial/cervical erosion, abrasion and/or gingival recession.
Gingival Health / Tooth Mobility Grade:Study teeth must have Löe and Silness Gingival Index (GI) score less than or equal to 2 and clinical mobility less than or equal to grade I.

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Current Product Use: Participants must have been using the same brand of toothpaste for at least 2 months and should not have used desensitizing toothpaste during the 4 weeks preceding screening. Participants will be required to bring in their current toothpaste(s) in order to verify the ingredients.
VAS Training: Successfully completes the VAS training exercise at Screening.
Sensitivity: Self-reported history of dentinal hypersensitivity and a primary complaint of sensitive teeth lasting a maximum of 10 years. At Screening: A minimum of 5 evaporative (air) sensitive lateral incisors, canines or pre-molars must display a response greater than 25 mm on a 100 mm VAS. At Baseline: A minimum of 3 of the 5 evaporative (air) sensitive teeth identified at screening must display a response greater than 25 mm on a 100 mm VAS. All teeth meeting the sensitivity Inclusion Criteria will be followed and assessed using both efficacy parameters.
Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.

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 (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. 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.

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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.
Xerostomia: Any condition or medication that causes xerostomia.
Personnel: An employee of the sponsor or the study site or members of their immediate family.
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

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

Other trials in United States

About this study

Official title: An Exploratory Clinical Study to Evaluate the Efficacy of Two Currently Marketed Toothpastes Containing Different Concentrations of a Tubule Occlusion Agent

To evaluate the efficacy of two different concentrations of a tubule occlusion agent - calcium sodium phosphosilicate in treatment of dentine hypersensitivity

Read the detailed description

Dentine hypersensitivity is characterized by short, sharp pain arising from exposed dentine typically in response to chemical, thermal, tactile or osmotic stimuli. Dentine hypersensitivity may be treated by either making the nerve in the tooth less sensitive or by occluding the tubules to limit exposure of the nerve to external stimuli. Bioactive and biocompatible glasses react with oral fluid to deposit a mineral that is chemically analogous to that found in both enamel and dentine thus preventing exposure of the nerve to external stimuli.

A number of controlled clinical trials have been reported indicating that a calcium sodium phosphosilicate bioactive glass, when incorporated into a toothpaste formulation, significantly reduce pain from dentine hypersensitivity. The aim of this study is to evaluate the effectiveness of two currently marketed toothpastes, containing 5% calcium sodium phosphosilicate and the other containing 7.5% calcium sodium phosphosilicate in the treatment of dentine hypersensitivity compared to a matched placebo control.

Conditions: Dentine Hypersensitivity, Dental Pain
Being tested: 5% calcium sodium phosphosilicate toothpaste, 7.5% calcium sodium phosphosilicate toothpaste, Placebo toothpaste
Keywords: sensitivity, occlusion
Medical subject headings: Dentin Sensitivity, Toothache, Hypersensitivity, Bites and Stings

What participants receive

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

5% calcium sodium phosphosilicate toothpasteDevice
Low concentration calcium sodium phosphosilicate tubule occlusion agent
7.5% calcium sodium phosphosilicate toothpasteDevice
High concentration calcium sodium phosphosilicate tubule occlusion agent
Placebo toothpasteDevice
Placebo toothpaste

Study groups in NCT01075256
Study group	Role	What they receive
5% calcium sodium phosphosilicate toothpaste	Active comparator	Participants to brush their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. Receives: Device: 5% calcium sodium phosphosilicate toothpaste
7.5% calcium sodium phosphosilicate toothpaste	Active comparator	Participants to brush their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. Receives: Device: 7.5% calcium sodium phosphosilicate toothpaste
Placebo toothpaste	Placebo comparator	Participants to brush their teeth for two minutes, twice daily for 15 days with placebo toothpaste. Receives: Device: Placebo toothpaste

What is being measured

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

Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15
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 and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Measured: Baseline to Day 15
Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15
Response of exposed dentine surface to application of 1 ml freshly melted ice cold water 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 and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Measured: Baseline to Day 15

Secondary outcomes (2)

Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7
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 and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Measured: Baseline to Day 7
Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7
Response of exposed dentine surface to application of 1 ml freshly melted ice cold water 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 and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Measured: Baseline to Day 7

Timeline

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

Dec 2008Mar 2009

First posted25 Feb 2010 (estimated)
Study startDec 2008
Primary completionMar 2009
Study completionMar 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 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 195 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01075256
Sponsor's protocol ID: Z3690607
Status last verified: Apr 2013
First submitted: 23 Feb 2010
Last updated: 3 Jun 2013
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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A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
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All Dentine Hypersensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Clinical Study to Evaluate the Efficacy of Two Currently Marketed Toothpastes Containing Different Concentrations of a Tubule Occlusion Agent
ClinicalTrials.gov ID: NCT01075256
Acronym / sponsor ID: Z3690607
Conditions: Dentine Hypersensitivity, Dental Pain
Keywords: sensitivity, occlusion
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 195 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 25 Feb 2010 (estimated)
Results: Posted 3 Jun 2013

Clinical summary

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

To evaluate the efficacy of two different concentrations of a tubule occlusion agent - calcium sodium phosphosilicate in treatment of dentine hypersensitivity

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
5% calcium sodium phosphosilicate toothpaste	Active comparator	Device: 5% calcium sodium phosphosilicate toothpasteParticipants to brush their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste.
7.5% calcium sodium phosphosilicate toothpaste	Active comparator	Device: 7.5% calcium sodium phosphosilicate toothpasteParticipants to brush their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste.
Placebo toothpaste	Placebo comparator	Device: Placebo toothpasteParticipants to brush their teeth for two minutes, twice daily for 15 days with placebo toothpaste.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Age: Aged between 20 - 50 years.
General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.
Contraception: Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
Erosion/Abrasion/Recession:Study teeth must show signs of facial/cervical erosion, abrasion and/or gingival recession.

Key exclusion criteria (10 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 (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. 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 toothpasteLow concentration calcium sodium phosphosilicate tubule occlusion agent	Device	5% calcium sodium phosphosilicate toothpaste
7.5% calcium sodium phosphosilicate toothpasteHigh concentration calcium sodium phosphosilicate tubule occlusion agent	Device	7.5% calcium sodium phosphosilicate toothpaste
Placebo toothpastePlacebo toothpaste	Device	Placebo toothpaste

Primary outcome

Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15
Time frame: Baseline to Day 15
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 and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.
Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15
Time frame: Baseline to Day 15
Response of exposed dentine surface to application of 1 ml freshly melted ice cold water 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 and a change of greater than 25 mm in VAS indicates potential relevant clinical significance of treatment.

2 secondary outcomes

Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a VAS at Day 7
Time frame: Baseline to Day 7
Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 7
Time frame: Baseline to Day 7

Results and safety

Results posted to the registry on 3 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
7.5% Sodium Calcium Phosphosilicate Toothpaste	64	63
5% Sodium Calcium Phosphosilicate Toothpaste	66	66
Placebo Toothpaste	65	65

Primary outcome: Adjusted Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15

Time frame: Baseline to Day 15. Mean (95% Confidence Interval). Unit: Units on a scale

Measure	7.5% Sodium Calcium Phosphosilicate Toothpaste n = 63	5% Sodium Calcium Phosphosilicate Toothpaste n = 66	Placebo Toothpaste n = 65
Value	-26.1 (-29.40 to -22.72)	-28.4 (-31.60 to -25.12)	-26.2 (-29.54 to -22.95)

5% Sodium Calcium Phosphosilicate Toothpaste vs Placebo Toothpaste: Adjusted Mean Difference: -2.1 (95% CI -6.70 to 2.46), p = 0.3628, ANCOVA
7.5% Sodium Calcium Phosphosilicate Toothpaste vs Placebo Toothpaste: Adjusted Mean Difference: 0.2 (95% CI -4.45 to 4.83), p = 0.9361, ANCOVA
7.5% Sodium Calcium Phosphosilicate Toothpaste vs 5% Sodium Calcium Phosphosilicate Toothpaste: Adjusted Mean difference: 2.3 (95% CI -2.31 to 6.92), p = 0.3257, ANCOVA

Population analysed: Intention to treat (ITT) population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.

Primary outcome: Adjusted Mean Change From Baseline in Cold Water Sensitivity Pain Response on a VAS at Day 15

Time frame: Baseline to Day 15. Mean (95% Confidence Interval). Unit: Units on a scale

Measure	7.5% Sodium Calcium Phosphosilicate Toothpaste n = 63	5% Sodium Calcium Phosphosilicate Toothpaste n = 66	Placebo Toothpaste n = 65
Value	-32.8 (-37.55 to -28.00)	-32.2 (-36.86 to -27.59)	-32.3 (-37.04 to -27.60)

5% Sodium Calcium Phosphosilicate Toothpaste vs Placebo Toothpaste: Adjusted Mean Difference: 0.1 (95% CI -6.34 to 6.54), p = 0.9759, ANCOVA
7.5% Sodium Calcium Phosphosilicate Toothpaste vs Placebo Toothpaste: Adjusted Mean Difference: -0.5 (95% CI -6.97 to 6.06), p = 0.8903, ANCOVA
7.5% Sodium Calcium Phosphosilicate Toothpaste vs 5% Sodium Calcium Phosphosilicate Toothpaste: Adjusted mean difference: -0.6 (95% CI -7.04 to 5.93), p = 0.8662, ANCOVA

Population analysed: ITT population: All randomized participants who received at least one dose of investigational product who have at least one post-baseline efficacy measure. Missing data was not imputed. Due to drop outs, there was difference in number of participants analyzed.

2 secondary outcomes are reported in the full results.

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 were recorded.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
7.5% Sodium Calcium Phosphosilicate Toothpaste	0 of 63 (0%)	3 of 63 (4.8%)	Not reported
5% Sodium Calcium Phosphosilicate Toothpaste	0 of 66 (0%)	3 of 66 (4.5%)	Not reported
Placebo Toothpaste	0 of 66 (0%)	3 of 66 (4.5%)	Not reported

Limitations and caveats (from the sponsor): An issue with study product packaging was discovered post-study completion. The nature indicated that subject response was likely to have been liable to a positive bias. Efficacy cannot be considered as valid and no reliable conclusions possible.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
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 10 inclusion and 10 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 3 Jun 2013. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 3 Jun 2013). 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 Air Sensitivity Pain Response on a Visual Analog Scale (VAS) at Day 15 (time frame: Baseline to Day 15). The study lists 2 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 NCT01075256.

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 3 Jun 2013.