Dentin SensitivityNCT01345292
A Study of the Relief of Tooth Sensitivity of an Experimental Mouthrinse Device
A study testing Mouthwash, Potassium nitrate toothpaste and Sodium fluoride toothpaste in people with Dentin Sensitivity, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site 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. During the first 2 weeks, you will just brush your teeth two times a day with the fluoride toothpaste provided. Then you will be assigned to a group if you qualify to continue in the study. 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?
- Mouthwash, Potassium nitrate toothpaste and Sodium fluoride toothpaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to May 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 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 trial.
- Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical trial.
- The appropriate number and location of eligible teeth, based on protocol-defined standards.
- Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
Who cannot join
- Any medical or dental history or condition, or use of any medication or drug, that per protocol or in the opinion of the investigator might compromise subject comfort or safety, or the analysis of study results.
- Volunteers who have been using any of the following within protocol-defined timeframes:
- home-care bleaching, whitening products or professional bleaching treatment
- desensitizing agents whether prescribed or over-the-counter
- sensitivity toothpastes, mouthwash or oral care products used for the treatment of dentinal hypersensitivity
- Women who are pregnant, nursing or plan to become pregnant during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
BioSci Research America, Inc.
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.
During the first 2 weeks, you will just brush your teeth two times a day with the fluoride toothpaste provided.
Read more
Then you will be assigned to a group if you qualify to continue in the study. All groups will get a marketed toothpaste and one group will also get a mouthwash with an experimental ingredient. You will have an equal chance of being assigned to any one of the three groups.
For the next 4 weeks, you will brush with your assigned toothpaste and rinse with your assigned mouthwash if assigned to the mouthwash group. A dentist will look at your mouth, teeth, tongue and gums and check for sensitive teeth. The investigators will see if the mouthwash helps to reduce tooth sensitivity during the study.
Read the detailed description
This is an observer-blind, randomized, parallel-group, single-center, controlled clinical trial. Approximately 246 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 210 subjects (70 per group) would reasonably be expected to complete the study. Subjects will have their oral soft/hard tissues assessed and will be evaluated for sensitivity levels at Screening (Visit 1), Baseline (Visit 2), Visit 3 at Week 2 and Visit 4 at Week 4. During the first two weeks of the study, subjects will be instructed to brush their teeth for one minute in their usual manner, twice daily, using the provided standard fluoride toothpaste. Subjects will return for the Baseline exam and, upon qualification with entry criteria, will be assigned to one of three treatment groups. Qualified subjects will be instructed to brush their teeth two times daily for one minute in their usual manner using the provided toothpaste (standard fluoride toothpaste or 5% potassium nitrate toothpaste). Subjects assigned to the mouthrinse group will be instructed to rinse twice daily, after brushing, with the provided mouthrinse for 60 seconds using 10 ml, for 4 consecutive weeks.
- Conditions
- Dentin Sensitivity
- Being tested
- Mouthwash, Potassium nitrate toothpaste, Sodium fluoride toothpaste
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MouthwashDevice
Also called 1.40% potassium oxalate sensitive mouthwash
Rinse with 10 ml of the assigned mouthwash for 60 seconds after you brush in your usual manner twice daily for one minute using at least a one-inch strip of the assigned toothpaste
Potassium nitrate toothpasteDrug
Also called 5% Potassium nitrate toothpaste, Sensodyne Original
Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
Sodium fluoride toothpasteDrug
Also called Crest Cavity Protection
Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
| Study group | Role | What they receive |
|---|---|---|
| 12027-027 | Experimental | Rinse with 10 ml of the assigned mouthwash for 60 seconds after you brush in your usual manner twice daily for one minute using at least a one-inch strip of the assigned toothpaste Receives: Device: Mouthwash |
| 310158077046 | Active comparator | Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste Receives: Drug: Potassium nitrate toothpaste |
| 037000003212 | Placebo comparator | Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste Receives: Drug: Sodium fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 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.
Measured: 2 weeks
Secondary outcomes (6)
Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2
Tooth sensitivity was measured using a 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 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
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 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 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 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
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 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 solicit your dentinal hypersensitivity pain/discomfort since you first started 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 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 solicit your dentinal hypersensitivity pain/discomfort since you first started 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 posted2 May 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2011
- Study completionMay 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 226 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, DMD, PhD, Study director, Johnson & Johnson Consumer and Personal Products Worldwide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345292
- Sponsor's protocol ID
- KOXDHY0005
- Status last verified
- Jun 2015
- First submitted
- 28 Apr 2011
- Last updated
- 10 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sharma D, McGuire JA, Gallob JT, Amini P. Randomised clinical efficacy trial of potassium oxalate mouthrinse in relieving dentinal sensitivity. J Dent. 2013 Jul;41 Suppl 4:S40-8. doi: 10.1016/S0300-5712(13)70005-8.
PubMed 23929644
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
- NCT01345292
- Acronym / sponsor ID
- KOXDHY0005
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 2 May 2011 (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.
During the first 2 weeks, you will just brush your teeth two times a day with the fluoride toothpaste provided.
Then you will be assigned to a group if you qualify to continue in the study. All groups will get a marketed toothpaste and one group will also get a mouthwash with an experimental ingredient. You will have an equal chance of being assigned to any one of the three groups.
For the next 4 weeks, you will brush with your assigned toothpaste and rinse with your assigned mouthwash if assigned to the mouthwash group. A dentist will look at your mouth, teeth, tongue and gums and check for sensitive teeth. The investigators will see if the mouthwash helps to reduce tooth sensitivity during the study.
Detailed description
This is an observer-blind, randomized, parallel-group, single-center, controlled clinical trial. Approximately 246 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 210 subjects (70 per group) would reasonably be expected to complete the study. Subjects will have their oral soft/hard tissues assessed and will be evaluated for sensitivity levels at Screening (Visit 1), Baseline (Visit 2), Visit 3 at Week 2 and Visit 4 at Week 4. During the first two weeks of the study, subjects will be instructed to brush their teeth for one minute in their usual manner, twice daily, using the provided standard fluoride toothpaste. Subjects will return for the Baseline exam and, upon qualification with entry criteria, will be assigned to one of three treatment groups. Qualified subjects will be instructed to brush their teeth two times daily for one minute in their usual manner using the provided toothpaste (standard fluoride toothpaste or 5% potassium nitrate toothpaste). Subjects assigned to the mouthrinse group will be instructed to rinse twice daily, after brushing, with the provided mouthrinse for 60 seconds using 10 ml, for 4 consecutive weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 12027-027 | Experimental | Device: MouthwashRinse with 10 ml of the assigned mouthwash for 60 seconds after you brush in your usual manner twice daily for one minute using at least a one-inch strip of the assigned toothpaste |
| 310158077046 | Active comparator | Drug: Potassium nitrate toothpasteBrush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste |
| 037000003212 | Placebo comparator | Drug: Sodium fluoride toothpasteBrush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 trial.
- Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical trial.
- The appropriate number and location of eligible teeth, based on protocol-defined standards.
- Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
Key exclusion criteria (6 listed)
- Any medical or dental history or condition, or use of any medication or drug, that per protocol or in the opinion of the investigator might compromise subject comfort or safety, or the analysis of study results.
- Volunteers who have been using any of the following within protocol-defined timeframes:
- Women who are pregnant, nursing or plan to become pregnant during the course of the study.
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 |
|---|---|---|
| MouthwashAlso: 1.40% potassium oxalate sensitive mouthwashRinse with 10 ml of the assigned mouthwash for 60 seconds after you brush in your usual manner twice daily for one minute using at least a one-inch strip of the assigned toothpaste | Device | 12027-027 |
| Potassium nitrate toothpasteAlso: 5% Potassium nitrate toothpaste, Sensodyne OriginalBrush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste | Drug | 310158077046 |
| Sodium fluoride toothpasteAlso: Crest Cavity ProtectionBrush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste | Drug | 037000003212 |
Primary outcome
Mean Tactile Sensitivity Score at Week 4
Time frame: 4 weeks
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.
Mean Tactile Sensitivity Score at Week 2
Time frame: 2 weeks
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.
6 secondary outcomes
Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2
Time frame: 2 weeks
Mean Tactile Sensitivity VAS Score at Week 4
Time frame: 4 weeks
Mean Cold Air Stimulus VAS Score at Week 2
Time frame: 2 weeks
Mean Cold Air Stimulus 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.
- Derived from this study: PubMed 23929644Sharma D, McGuire JA, Gallob JT, Amini P. Randomised clinical efficacy trial of potassium oxalate mouthrinse in relieving dentinal sensitivity. J Dent. 2013 Jul;41 Suppl 4:S40-8. doi: 10.1016/S0300-5712(13)70005-8.
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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, DMD, PhD study director
Johnson & Johnson Consumer and Personal Products Worldwide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthwash, Potassium nitrate toothpaste and Sodium fluoride toothpaste in people with Dentin Sensitivity, run by Johnson & Johnson Consumer and Personal Products Worldwide 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 5 inclusion and 6 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 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.
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?
Mean Tactile Sensitivity Score at Week 4 (time frame: 4 weeks). 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 NCT01345292, which also lists 1 linked publication.
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.