Tooth HypersensitivityNCT01669785
NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study
A study testing Group C, Group A and Group B 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?
- Group C, Group A and Group B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to May 2012
- 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.
- Two sensitive teeth, which are not adjacent to each other and preferably in different quadrants, which 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.
- Subjects need to satisfy the qualifying response to stimuli for both parameters assesses (Tactile or Air Blast) on at least two teeth (non-adjacent) to be entered into the study.
- Good general health with no known allergies to products being tested.
- Use of a non-desensitizing dentifrice for 2 weeks prior to entry into the study.
- Subjects must have a minimum of 10 natural 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 18Show 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 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; b0 A member or relative of teh study site staff directly involved with the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NUPRO Sensodyne Prophylaxis Paste With NovaMin 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 will give patients immediate sensitivity relief, as well as sensitivity relief up to 4 weeks (28 days) after measurement.
- Conditions
- Tooth Hypersensitivity
- Being tested
- Group C, Group A, Group B
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CDevice
Also called NUPRO Classic Prophy Paste
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Group ADevice
Also called NUPRO Sensodyne Prophy Paste with NovaMin with Fluoride.
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
Group BDevice
Also called NUPRO Sensodyne Prophy Paste with NovaMin without Fluoride.
Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | NUPRO Classic Prophy Paste
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..
Leave in contact for 60 seconds, rinse with water and expectorate. Receives: Device: Group C |
| Group A | Experimental | NUPRO Sensodyne Prophy Paste w/ Novamin
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.
Leave in contact for 60 seconds, rinse with water and expectorate Receives: Device: Group B |
| Group B | Experimental | NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride
Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.
Leave in contact for 60 seconds, rinse with water and expectorate. Receives: Device: Group A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Pre-Prophy Assessment (Tactile Sensitivity)
Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Measured: Pre-treatment measurement
Immediate Sensitivity Relief (Tactile Sensitivity)
Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Measured: Immediately after treatment .
Long-term Sensitivity Relief (Tactile Sensitivity)
Assessment of sensitivity score via tactile measurements long term after treatment.
Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Measured: 28 days (+/- 2 days) post treatment.
Baseline Pre-Prophy Assessment (Air Blast Sensitivity)
Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Measured: Pre-treatment measurement
Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)
Assessment of sensitivity score via air blast measurements immediately after treatment.
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Measured: Immediately after treatment .
Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)
Assessment of sensitivity score Schiff air blast measurements long term after treatment.
Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:
0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Measured: 28 days (+/- 2 days) post treatment.
Secondary outcomes (4)
Sensitivity Relief (Self-Assessment)
All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity prior to the baseline assessments.
The questionnaire contained a 4-item verbal descriptor scale as follows:
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Measured: Pre-Treatment
Post- Scaling Sensitivity Relief (Self-Assessment)
All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.
The questionnaire contained a 4-item verbal descriptor scale as follows:
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Measured: Post-scaling procedure,immediate
Post-prophylaxis Sensitivity Relief (Self-Assessment)
All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.
The questionnaire contained a 4-item verbal descriptor scale as follows:
Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Measured: Immediately following post-prophylaxis treatment.
Long-term Sensitivity Relief (Self-Assessment)
All subjects completed a questionnaire titled "How sensitive are your teeth?" to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.
The questionnaire contained a 4-item verbal descriptor scale as follows:
Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.
The higher the score, the higher the hypersensitivity.
Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Measured: 28 days post-prophylaxis treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionMay 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 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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey L Milleman, DDS, MPA, Principal investigator, Salus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669785
- Sponsor's protocol ID
- CTP-002
- Status last verified
- Aug 2014
- First submitted
- 8 Jun 2012
- Last updated
- 21 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUPRO Sensodyne Prophylaxis Paste With NovaMin for the Treatment of Dentin Hypersensitivity.
- ClinicalTrials.gov ID
- NCT01669785
- Acronym / sponsor ID
- CTP-002
- Conditions
- Tooth Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Dentsply InternationalIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Posted 21 Aug 2014
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 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 |
|---|---|---|
| Group C | Active comparator | Device: Group CNUPRO Classic Prophy Paste Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.. Leave in contact for 60 seconds, rinse with water and expectorate. |
| Group A | Experimental | Device: Group BNUPRO Sensodyne Prophy Paste w/ Novamin Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride. Leave in contact for 60 seconds, rinse with water and expectorate |
| Group B | Experimental | Device: Group ANUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin. Leave in contact for 60 seconds, rinse with water and expectorate. |
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.
- Two sensitive teeth, which are not adjacent to each other and preferably in different quadrants, which 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.
- Subjects need to satisfy the qualifying response to stimuli for both parameters assesses (Tactile or Air Blast) on at least two teeth (non-adjacent) to be entered into the study.
Key exclusion criteria (18 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 |
|---|---|---|
| Group CAlso: NUPRO Classic Prophy PasteAbrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. | Device | Group C |
| Group AAlso: NUPRO Sensodyne Prophy Paste with NovaMin with Fluoride.Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. | Device | Group B |
| Group BAlso: NUPRO Sensodyne Prophy Paste with NovaMin without Fluoride.Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth. | Device | Group A |
Primary outcome
Baseline Pre-Prophy Assessment (Tactile Sensitivity)
Time frame: Pre-treatment measurement
Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Immediate Sensitivity Relief (Tactile Sensitivity)
Time frame: Immediately after treatment .
Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Long-term Sensitivity Relief (Tactile Sensitivity)
Time frame: 28 days (+/- 2 days) post treatment.
Assessment of sensitivity score via tactile measurements long term after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity. Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Baseline Pre-Prophy Assessment (Air Blast Sensitivity)
Time frame: Pre-treatment measurement
Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3). Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows: 0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation. The higher the score, the higher the hypersensitivity. Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)
Time frame: Immediately after treatment .
Assessment of sensitivity score via air blast measurements immediately after treatment. Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows: 0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation. Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)
Time frame: 28 days (+/- 2 days) post treatment.
Assessment of sensitivity score Schiff air blast measurements long term after treatment. Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows: 0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation. Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth.
4 secondary outcomes
Sensitivity Relief (Self-Assessment)
Time frame: Pre-Treatment
Post- Scaling Sensitivity Relief (Self-Assessment)
Time frame: Post-scaling procedure,immediate
Post-prophylaxis Sensitivity Relief (Self-Assessment)
Time frame: Immediately following post-prophylaxis treatment.
Long-term Sensitivity Relief (Self-Assessment)
Time frame: 28 days post-prophylaxis treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 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.
Jeffrey L Milleman, DDS, MPA 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 Group C, Group A and Group B 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 18 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 21 Aug 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 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?
Baseline Pre-Prophy Assessment (Tactile Sensitivity) (time frame: Pre-treatment measurement). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2014; AzTrials last refreshed its copy on 1 Nov 2026.