Dentin SensitivityNCT01727258
A Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity
A study testing Mouth Rinse, Fluoride Toothpaste and Potassium Nitrate 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. At each visit the dentist will look at the mouth, teeth, tongue and gums of subjects, 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?
- Mouth Rinse, Fluoride Toothpaste and Potassium Nitrate Toothpaste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Feb 2013
- 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
- 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
- Dental condition appropriate for inclusion in the trial according to protocol-specified parameters and the professional opinion of the investigator
- Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect
Who cannot join
- Medical condition or history, or use of drugs or treatments that could possibly compromise the safety of the research subject or the interpretation of results, per protocol or in the opinion of the investigator
- Use of home-care bleaching, whitening products or professional bleaching treatment within a protocol-specified time period
- Use of desensitizing agents within a protocol-specified time period
- Participation in a dental clinical trial involving oral care products within a protocol-specified time period
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: Evaluation of an Experimental Mouth Rinse Device for Relieving 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 subjects, and check for sensitive teeth.
During the first 2 weeks, participants will brush their teeth two times a day with the fluoride toothpaste provided.
Read more
Then, if they qualify to continue in the study, participants will be assigned to a treatment group. All the groups will get toothpaste currently sold on the market, and one group will get a mouthwash with an experimental ingredient to use as well. Subjects will have an equal chance of being assigned to any one of the three groups.
For the next 4 weeks, subjects will use their assigned products according to the directions provided. At Visit 1 subjects will be supervised while they brush their teeth to ensure they understand the directions. They will also have supervised use of the product at Visit 2.
We will see if the mouthwash helps 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, subjects 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 subjects will use a sodium fluoride dentifrice. At the start of the first phase, subjects 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.
Subjects 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. Subjects who continue to qualify through Baseline will be randomized to one of three treatment groups.
During the four-week treatment period, all subjects will brush their teeth twice daily for at least one minute in their usual manner, with their assigned toothpaste. After brushing, subjects assigned to the mouth rinse group will rinse with water, and then rinse with 10 mL of the experimental mouth rinse for 60 seconds.
The study duration is approximately six weeks with each subject visiting the clinical site six times.
Adverse events will be observed and collected by querying each subject at each visit for new or continuing symptoms.
- Conditions
- Dentin Sensitivity
- Being tested
- Mouth Rinse, Fluoride Toothpaste, Potassium Nitrate Toothpaste
- 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.
Mouth RinseDevice
Mouth rinse 12027-033 used twice daily for 28 days after brushing.
Fluoride ToothpasteDrug
Also called Colgate® Cavity Protection Regular
Fluoride Toothpaste used daily for 28 days.
Potassium Nitrate ToothpasteDrug
Also called Sensodyne® Original
Potassium Nitrate Toothpaste used daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Mouth Rinse | Experimental | Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of Fluoride Toothpaste provided. Rinse with water after brushing teeth. Then rinse for 60 seconds with 10 mL of the experimental Mouth Rinse 12027-033 (KOX). Receives: Device: Mouth Rinse; Drug: Fluoride Toothpaste |
| Fluoride Toothpaste | Active comparator | Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Fluoride Toothpaste (NEG) provided. Receives: Drug: Fluoride Toothpaste |
| Potassium Nitrate Toothpaste | Active comparator | Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Potassium Nitrate Toothpaste (POS) provided. Receives: Drug: Potassium Nitrate 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 (4)
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
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 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 153 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
- NCT01727258
- Sponsor's protocol ID
- KOXDHY0008
- Status last verified
- Apr 2015
- First submitted
- 12 Nov 2012
- 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
- Evaluation of an Experimental Mouth Rinse Device for Relieving Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT01727258
- Acronym / sponsor ID
- KOXDHY0008
- Conditions
- Dentin Sensitivity
- Keywords
- Tooth Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Nov 2012 (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 subjects, and check for sensitive teeth.
During the first 2 weeks, participants will brush their teeth two times a day with the fluoride toothpaste provided.
Then, if they qualify to continue in the study, participants will be assigned to a treatment group. All the groups will get toothpaste currently sold on the market, and one group will get a mouthwash with an experimental ingredient to use as well. Subjects will have an equal chance of being assigned to any one of the three groups.
For the next 4 weeks, subjects will use their assigned products according to the directions provided. At Visit 1 subjects will be supervised while they brush their teeth to ensure they understand the directions. They will also have supervised use of the product at Visit 2.
We will see if the mouthwash helps to reduce tooth sensitivity during the study.
Detailed description
This study will consist of run-in and treatment phases. To qualify for the study, subjects 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 subjects will use a sodium fluoride dentifrice. At the start of the first phase, subjects 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.
Subjects 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. Subjects who continue to qualify through Baseline will be randomized to one of three treatment groups.
During the four-week treatment period, all subjects will brush their teeth twice daily for at least one minute in their usual manner, with their assigned toothpaste. After brushing, subjects assigned to the mouth rinse group will rinse with water, and then rinse with 10 mL of the experimental mouth rinse for 60 seconds.
The study duration is approximately six weeks with each subject visiting the clinical site six times.
Adverse events will be observed and collected by querying each subject at each visit for new or continuing symptoms.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mouth Rinse | Experimental | Device: Mouth Rinse, Drug: Fluoride ToothpasteTwice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of Fluoride Toothpaste provided. Rinse with water after brushing teeth. Then rinse for 60 seconds with 10 mL of the experimental Mouth Rinse 12027-033 (KOX). |
| Fluoride Toothpaste | Active comparator | Drug: Fluoride ToothpasteTwice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Fluoride Toothpaste (NEG) provided. |
| Potassium Nitrate Toothpaste | Active comparator | Drug: Potassium Nitrate ToothpasteTwice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Potassium Nitrate Toothpaste (POS) provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Dental condition appropriate for inclusion in the trial according to protocol-specified parameters and the professional opinion of the investigator
- Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect
Key exclusion criteria (4 listed)
- Medical condition or history, or use of drugs or treatments that could possibly compromise the safety of the research subject or the interpretation of results, per protocol or in the opinion of the investigator
- Use of home-care bleaching, whitening products or professional bleaching treatment within a protocol-specified time period
- Use of desensitizing agents within a protocol-specified time period
- Participation in a dental clinical trial involving oral care products within a protocol-specified time period
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 |
|---|---|---|
| Mouth RinseMouth rinse 12027-033 used twice daily for 28 days after brushing. | Device | Mouth Rinse |
| Fluoride ToothpasteAlso: Colgate® Cavity Protection RegularFluoride Toothpaste used daily for 28 days. | Drug | Fluoride Toothpaste, Mouth Rinse |
| Potassium Nitrate ToothpasteAlso: Sensodyne® OriginalPotassium Nitrate Toothpaste used daily for 28 days. | Drug | Potassium Nitrate Toothpaste |
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.
4 secondary outcomes
Mean Tactile Sensitivity 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
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, 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 Mouth Rinse, Fluoride Toothpaste and Potassium Nitrate 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 4 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. 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?
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.