Dentin SensitivityNCT02113579
Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity
A study testing Experimental Mouth Rinse 12027-033 in people with Dentin Sensitivity, run by Johnson & Johnson Consumer and Personal Products Worldwide at 2 sites in United States.
Trial summary
This study is for people with sensitive teeth and involves going to the dentist for 4 visits over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of participants, and check for sensitive teeth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Experimental Mouth Rinse 12027-033
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females at least 18 years of age in good general and oral health without any known allergy to commercial dental products or cosmetics.
- Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the study
- Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study. Acceptable methods for this study include:
- Abstinence
- Birth control pills, patches, vaginal rings, implants or injections
- Intrauterine device
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- Double barrier method (condom/diaphragm or cervical cap with spermicide)
- Bilateral tubal ligation
- Hysterectomy
- Ovariectomy
- Male partner vasectomy
- Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical study.
- A minimum of 2 natural premolars, canines, and/or incisors teeth with decay-free scorable facial/buccal surfaces which must present cervical abrasion, and/or erosion and/or gingival recession.
- A minimum of two eligible teeth (premolars, canines and/or incisors) with a Screening (-2 weeks Baseline) and Baseline cold air stimulus Visual Analogue Scale (VAS) score of 40 - 80 mm on a 100 mm VAS scale, tactile sensitivity score between 10 - 30 grams after application of the Yeaple probe and a tactile (Yeaple probe) VAS of 40 -80 mm on a 100 mm VAS scale.
- No more than two eligible teeth per quadrant each separated by 2 other teeth must be selected.
- Absence of significant oral soft tissue pathology, based on the dentist's visual examination and at the discretion of the investigator.
- Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect).
- Absence of severe marginal gingivitis, moderate/advanced periodontitis (ADA Type III, IV) based on a clinical examination and discretion of the Investigator.
- Absence of extensive absence of extensive calculus above the gum line.
Who cannot join
- Volunteers who report history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients.
- Volunteers with eating disorders, uncontrolled Gastroesophageal reflux disease GERD or Acid Reflux, excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity.
- Volunteers with chronic medical debilitating disease associated with constant or intermittent episodes of daily pain.
- Long-term daily use (≥ 7 consecutive days) of analgesics and any other drugs that at the discretion of the Investigator would compromise the response of the hypersensitivity assessments.
- Volunteers who have been using any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Screening visit.
- Use of desensitizing agents whether prescribed or over-the-counter within eight weeks prior to screening visit (any sensitivity toothpastes such as Crest Sensitivity, Sensodyne, Crest Pro-Health, Colgate Sensitivity Relief, any mouthwash and oral care products used for the treatment of dentinal hypersensitivity).
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- Volunteers who during the study will receive dental treatment which may affect their dentinal hypersensitivity condition (i.e., oral prophylaxis). Emergency treatment will be allowed.
- Those with a known allergy to study products' ingredients.
- Those requiring antibiotic premedication prior to invasive dental procedures.
- Participation in a dental clinical study involving oral care products within the past 30 days.
- Self reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results)
- Teeth that are grossly carious, orthodontically banded, abutment teeth for fixed or removable prostheses, crowned teeth, or third molars will not be included in the study.
- Periodontal surgery and orthodontic treatment within previous 3 months.
- Extensive restorative treatment (i.e. extensively restored teeth or teeth with restoration(s) extending into the test area) at the discretion of the Investigator.
- Dental prophylaxis within 2 weeks prior to Screening visit.
- Teeth or periodontium with pathology or defect likely to cause pain.
- Teeth with clinical mobility > grade 1.
- Relative, partner or staff of any clinical research site personnel
- Participation in any clinical study within 30 days of Visit 1.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Salus Research, Inc.
Fort Wayne, Indiana, 46825
Silverstone
Las Vegas, Nevada, 89121
About this study
Official title: Assessment of a Potassium Oxalate Containing Formulation for the Relief of Dentinal Hypersensitivity
This study is for people with sensitive teeth and involves going to the dentist for 4 visits over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of participants, and check for sensitive teeth.
During the first 2 weeks, participants will brush their teeth 2 times a day with the fluoride toothpaste provided.
Read more
Then, if they qualify to continue in the study, participants will be assigned to one of two treatment groups for the last 4 weeks. Both groups will use assigned toothpaste currently sold on the market. Both groups will each have an investigative mouth rinse to use as well. Participants will have an equal chance of being assigned to any one of the three groups.
For the next 4 weeks, participants will use their assigned products according to the directions provided. At Visit 1, participants will be supervised while they brush their teeth to ensure they understand the directions. They will also have supervised use of the products at Visit 2.
Results will be analyzed to assess whether the mouthwashes help to reduce tooth sensitivity during the study.
Read the detailed description
This study will consist of run-in and treatment phases. To qualify for the study, participants must meet the inclusion/exclusion criteria and return tactile sensitivity scores within protocol-specified parameters at both the screening and baseline visits.
Run-in will consist of a 2-week period during which participants will use a sodium fluoride dentifrice. At the start of the first phase, participants will attend a Screening Visit. They will participate in the informed consent process, complete a medical/dental history, and be evaluated for tactile sensitivity to Yeaple probe and response to a cold air stimulus.
Participants who qualify through screening will begin a run-in period that will last approximately two weeks. The run-in period will be followed by a Baseline visit. Participants who continue to qualify through Baseline will be randomly assigned to one of two treatment groups.
During the four-week treatment period, all participants will brush their teeth twice daily for at least one minute in their usual manner, with their assigned toothpaste. After brushing, participants will rinse with water, and then rinse with 10 mL of their assigned experimental mouth rinse for 60 seconds.
The study duration is approximately six weeks with each participant visiting the clinical site four times.
Adverse events will be observed and collected by querying each participant at each visit for new or continuing symptoms.
- Conditions
- Dentin Sensitivity
- Being tested
- Experimental Mouth Rinse 12027-033, Placebo Mouth Rinse
- Keywords
- Tooth Sensitivity
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Mouth Rinse 12027-033Device
Also called Fluoride Toothpaste / Crest® Cavity Protection Regular
After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily.
Placebo Mouth RinseOther
Also called Fluoride Toothpaste/Crest® Cavity Protection Regular
After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| KOX | Experimental | After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily.
Fluoride Toothpaste / Crest® Cavity Protection Regular and Experimental Mouth Rinse 12027-033 Receives: Device: Experimental Mouth Rinse 12027-033 |
| PLA | Placebo comparator | After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily.
Fluoride Toothpaste/Crest® Cavity Protection Regular and Placebo Mouth Rinse Receives: Other: Placebo Mouth Rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4
Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.
Measured: 4 Weeks
Secondary outcomes (9)
Mean Cold Air Stimulus VAS Score at Week 4
Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
Measured: 4 Weeks
Mean Tactile Sensitivity Score at Week 4
Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.
Measured: 4 Weeks
Mean Cold Air Stimulus VAS Score at Week 2
Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
Measured: 2 Weeks
Mean Tactile Sensitivity Score at Week 2
Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.
Measured: 2 Weeks
Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2
Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 2 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.
Measured: 2 Weeks
Mean Tactile Sensitivity VAS Score at Week 2
Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
Measured: 2 Weeks
Mean Tactile Sensitivity VAS Score at Week 4
Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.
Measured: 4 Weeks
Global Subjective VAS Score at Week 2
At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:"Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product." The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.
Measured: 2 Weeks
Global Subjective VAS Score at Week 4
At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:"Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product." The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
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 Dentin SensitivityStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lynch, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113579
- Sponsor's protocol ID
- KOXDHY0009
- Status last verified
- May 2015
- First submitted
- 8 Apr 2014
- Last updated
- 10 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Potassium Oxalate Containing Formulation for the Relief of Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT02113579
- Acronym / sponsor ID
- KOXDHY0009
- Conditions
- Dentin Sensitivity
- Keywords
- Tooth Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Posted 10 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for people with sensitive teeth and involves going to the dentist for 4 visits over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of participants, and check for sensitive teeth.
During the first 2 weeks, participants will brush their teeth 2 times a day with the fluoride toothpaste provided.
Then, if they qualify to continue in the study, participants will be assigned to one of two treatment groups for the last 4 weeks. Both groups will use assigned toothpaste currently sold on the market. Both groups will each have an investigative mouth rinse to use as well. Participants will have an equal chance of being assigned to any one of the three groups.
For the next 4 weeks, participants will use their assigned products according to the directions provided. At Visit 1, participants will be supervised while they brush their teeth to ensure they understand the directions. They will also have supervised use of the products at Visit 2.
Results will be analyzed to assess whether the mouthwashes help to reduce tooth sensitivity during the study.
Detailed description
This study will consist of run-in and treatment phases. To qualify for the study, participants must meet the inclusion/exclusion criteria and return tactile sensitivity scores within protocol-specified parameters at both the screening and baseline visits.
Run-in will consist of a 2-week period during which participants will use a sodium fluoride dentifrice. At the start of the first phase, participants will attend a Screening Visit. They will participate in the informed consent process, complete a medical/dental history, and be evaluated for tactile sensitivity to Yeaple probe and response to a cold air stimulus.
Participants who qualify through screening will begin a run-in period that will last approximately two weeks. The run-in period will be followed by a Baseline visit. Participants who continue to qualify through Baseline will be randomly assigned to one of two treatment groups.
During the four-week treatment period, all participants will brush their teeth twice daily for at least one minute in their usual manner, with their assigned toothpaste. After brushing, participants will rinse with water, and then rinse with 10 mL of their assigned experimental mouth rinse for 60 seconds.
The study duration is approximately six weeks with each participant visiting the clinical site four times.
Adverse events will be observed and collected by querying each participant at each visit for new or continuing symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KOX | Experimental | Device: Experimental Mouth Rinse 12027-033After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily. Fluoride Toothpaste / Crest® Cavity Protection Regular and Experimental Mouth Rinse 12027-033 |
| PLA | Placebo comparator | Other: Placebo Mouth RinseAfter brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily. Fluoride Toothpaste/Crest® Cavity Protection Regular and Placebo Mouth Rinse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Males and females at least 18 years of age in good general and oral health without any known allergy to commercial dental products or cosmetics.
- Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the study
- Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study. Acceptable methods for this study include:
- Abstinence
- Birth control pills, patches, vaginal rings, implants or injections
Key exclusion criteria (19 listed)
- Volunteers who report history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients.
- Volunteers with eating disorders, uncontrolled Gastroesophageal reflux disease GERD or Acid Reflux, excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity.
- Volunteers with chronic medical debilitating disease associated with constant or intermittent episodes of daily pain.
- Long-term daily use (≥ 7 consecutive days) of analgesics and any other drugs that at the discretion of the Investigator would compromise the response of the hypersensitivity assessments.
- Volunteers who have been using any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Screening visit.
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 |
|---|---|---|
| Experimental Mouth Rinse 12027-033Also: Fluoride Toothpaste / Crest® Cavity Protection RegularAfter brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily. | Device | KOX |
| Placebo Mouth RinseAlso: Fluoride Toothpaste/Crest® Cavity Protection RegularAfter brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily. | Other | PLA |
Primary outcome
Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4
Time frame: 4 Weeks
Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.
9 secondary outcomes
Mean Cold Air Stimulus VAS Score at Week 4
Time frame: 4 Weeks
Mean Tactile Sensitivity Score at Week 4
Time frame: 4 Weeks
Mean Cold Air Stimulus VAS Score at Week 2
Time frame: 2 Weeks
Mean Tactile Sensitivity Score at Week 2
Time frame: 2 Weeks
Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2
Time frame: 2 Weeks
Mean Tactile Sensitivity VAS Score at Week 2
Time frame: 2 Weeks
Mean Tactile Sensitivity VAS Score at Week 4
Time frame: 4 Weeks
Global Subjective VAS Score at Week 2
Time frame: 2 Weeks
Global Subjective VAS Score at Week 4
Time frame: 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 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.
Michael Lynch study director
Johnson & Johnson Consumer and Personal Products Worldwide
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Mouth Rinse 12027-033 in people with Dentin Sensitivity, run by Johnson & Johnson Consumer and Personal Products Worldwide at 2 sites 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 19 inclusion and 19 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 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 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?
Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4 (time frame: 4 Weeks). 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 10 Jun 2015.