Tooth HypersensitivityNCT01610167
NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study
A study testing NUPRO Classic Prophy Paste, NUPRO Sensodyne Prophy Paste with Novamin with fluoride. and NUPRO Sensodyne Prophy Paste with Novamin without fluoride. in people with Tooth Hypersensitivity, run by Dentsply International at 1 site in United States.
Trial summary
The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Hypersensitivity
- What is being tested?
- NUPRO Classic Prophy Paste, NUPRO Sensodyne Prophy Paste with Novamin with fluoride. and NUPRO Sensodyne Prophy Paste with Novamin without fluoride.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2011
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Availability to complete in the 28 day duration of the study.
- Two sensitive teeth which are not adjacent to each other and preferably in different quadrants and demonstrate cervical erosion, abrasion, and gingival recession.
- qualifying response to tactile stimuli as defined by a score of </= 20 grams.
- Qualifying response to air blast stimuli as defined by a score of >/= 1 on the Schiff Cold Air Sensitivity Scale.
- Good general health with no known allergies to products being tested.
- Use of a non-desensitizing dentifrice for 3 weeks prior to entry into the study.
- Able to follow study procedures and instructions.
- Must have a minimum of 10 natural evaluable teeth, excluding 3rd molars.
Who cannot join
- Individuals who exhibit gross oral pathology
- Females who may be pregnant or lactating or intending to become pregnant
- Individuals who require anesthetic during scaling
- Dental pathology which may cause pain similar to tooth sensitivity
- Individuals with large amounts of calculus
- Subjects with active infectious diseases such as hepatitis, HIV or tuberculosis
Show all 20Show fewer
- Any condition requiring antibiotic prophylaxis for dental treatment
- Excessive gingival inflammation
- Individuals who had their teeth cleaned within 30 days of the screening appointment
- Individuals who have had a desensitizing treatment or tooth bleaching within 90 days of screening appointment.
- Oral pathology, chronic disease, or history of allergy to test products
- Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
- Sensitive teeth with mobility greater than one.
- Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
- Regular use of sedatives, anti-inflammatory drugs, or analgesic
- Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past 4 weeks.
- Current participation in any other clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.
- Personnel; a) An employee of the sponsor; b) A member or relative of the study site staff directly involved with the study.
- Allergies to oral care products, personal care consumer products, or their ingredients.
- Any subject who, in the judgment of the investigator, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r) for the Treatment of Dentin Hypersensitivity.
The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days.
Read the detailed description
It is hypothesized that the prophy paste with NovaMin(r)will give patients immediate sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.
- Conditions
- Tooth Hypersensitivity
- Being tested
- NUPRO Classic Prophy Paste, NUPRO Sensodyne Prophy Paste with Novamin with fluoride., NUPRO Sensodyne Prophy Paste with Novamin without fluoride.
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUPRO Classic Prophy PasteDevice
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
NUPRO Sensodyne Prophy Paste with Novamin with fluoride.Device
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
NUPRO Sensodyne Prophy Paste with Novamin without fluoride.Device
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
| Study group | Role | What they receive |
|---|---|---|
| NUPRO(r) Classic Prophy Paste | Active comparator | Not described Receives: Device: NUPRO Classic Prophy Paste |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ fluoride. | Experimental | Not described Receives: Device: NUPRO Sensodyne Prophy Paste with Novamin with fluoride. |
| NUPRO Sensodyne Prophy Paste w/ Novamin | Experimental | Not described Receives: Device: NUPRO Sensodyne Prophy Paste with Novamin without fluoride. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Sensitivity Relief. Tactile Sensitivity.
Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a "yes" response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment.
Measured: Immediately after treatment.
Adverse Events.
Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).
Measured: Immediately after treatment to 28 days (+/- 2 days) post treatment.
Immediate Sensitivity Relief. Air Blast Sensitivity.
Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment.
Measured: Immediately after treatment.
Secondary outcomes (2)
Extended Sensitivity Relief. Tactile Sensitivity.
Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with "yes" response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination.
Measured: 28 days (+/- 2 days) post treatment.
Extended Sensitivity Relief. Air Blast Sensitivity.
Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth.
Measured: 28 days (+/- 2 days) post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
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 Tooth HypersensitivityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery L. Milleman, DDS, MPA, Principal investigator, Salus ResearchKimberly R. Milleman, ASDH, MS, Principal investigator, Salus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610167
- Sponsor's protocol ID
- CTP-001
- Status last verified
- Aug 2013
- First submitted
- 30 May 2012
- Last updated
- 14 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r) for the Treatment of Dentin Hypersensitivity.
- ClinicalTrials.gov ID
- NCT01610167
- Acronym / sponsor ID
- CTP-001
- Conditions
- Tooth Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Dentsply InternationalIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Posted 14 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days.
Detailed description
It is hypothesized that the prophy paste with NovaMin(r)will give patients immediate sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NUPRO(r) Classic Prophy Paste | Active comparator | Device: NUPRO Classic Prophy Paste |
| NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ fluoride. | Experimental | Device: NUPRO Sensodyne Prophy Paste with Novamin with fluoride. |
| NUPRO Sensodyne Prophy Paste w/ Novamin | Experimental | Device: NUPRO Sensodyne Prophy Paste with Novamin without fluoride. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Availability to complete in the 28 day duration of the study.
- Two sensitive teeth which are not adjacent to each other and preferably in different quadrants and demonstrate cervical erosion, abrasion, and gingival recession.
- qualifying response to tactile stimuli as defined by a score of </= 20 grams.
- Qualifying response to air blast stimuli as defined by a score of >/= 1 on the Schiff Cold Air Sensitivity Scale.
- Good general health with no known allergies to products being tested.
Key exclusion criteria (20 listed)
- Individuals who exhibit gross oral pathology
- Females who may be pregnant or lactating or intending to become pregnant
- Individuals who require anesthetic during scaling
- Dental pathology which may cause pain similar to tooth sensitivity
- Individuals with large amounts of calculus
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 |
|---|---|---|
| NUPRO Classic Prophy PasteAbrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. | Device | NUPRO(r) Classic Prophy Paste |
| NUPRO Sensodyne Prophy Paste with Novamin with fluoride.Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. | Device | NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ fluoride. |
| NUPRO Sensodyne Prophy Paste with Novamin without fluoride.Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. | Device | NUPRO Sensodyne Prophy Paste w/ Novamin |
Primary outcome
Immediate Sensitivity Relief. Tactile Sensitivity.
Time frame: Immediately after treatment.
Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a "yes" response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment.
Adverse Events.
Time frame: Immediately after treatment to 28 days (+/- 2 days) post treatment.
Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).
Immediate Sensitivity Relief. Air Blast Sensitivity.
Time frame: Immediately after treatment.
Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment.
2 secondary outcomes
Extended Sensitivity Relief. Tactile Sensitivity.
Time frame: 28 days (+/- 2 days) post treatment.
Extended Sensitivity Relief. Air Blast Sensitivity.
Time frame: 28 days (+/- 2 days) post treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Tooth Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity
Not yet recruiting
Nano Silver Fluoride and Photobiomodulation Therapy for Hypersensitivity and Pain in MIH-Affected Molars
Molar-Incisor Hypomineralization (MIH)
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.
Jeffery L. Milleman, DDS, MPA principal investigator
Salus Research
Kimberly R. Milleman, ASDH, MS principal investigator
Salus Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUPRO Classic Prophy Paste, NUPRO Sensodyne Prophy Paste with Novamin with fluoride. and NUPRO Sensodyne Prophy Paste with Novamin without fluoride. in people with Tooth Hypersensitivity, run by Dentsply International 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 8 inclusion and 20 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 14 Oct 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 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?
Immediate Sensitivity Relief. Tactile Sensitivity. (time frame: Immediately after 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?
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 14 Oct 2013.