Dentin SensitivityNCT02221349
A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
A study testing Potassium oxalate, Sodium fluoride paste and Stannous fluoride paste in people with Dentin Sensitivity, run by Procter and Gamble at 1 site in United States.
Trial summary
This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- Potassium oxalate, Sodium fluoride paste and Stannous fluoride paste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form
- Complete a confidentiality disclosure agreement
- Be in good general health as determined by the Investigator/designee
- Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the air challenge.
Who cannot join
- Self-reported pregnancy or nursing
- Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
- Active treatment of periodontitis
- Fixed facial orthodontic appliances
- A history of kidney stones
- Known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
- Any diseases or conditions that might interfere with the safe completion of the study
- An inability to undergo any study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.
- Conditions
- Dentin Sensitivity
- Being tested
- Potassium oxalate, Sodium fluoride paste, Stannous fluoride paste
- Keywords
- Sensitivity
- Medical subject headings
- Dentin Sensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium oxalateDevice
Professionally applied (liquid) and self applied (gel)
Sodium fluoride pasteDrug
Also called NaF paste
Toothpaste used by subject
Stannous fluoride pasteDrug
Also called SnF2 paste
Toothpaste used by subject
| Study group | Role | What they receive |
|---|---|---|
| oxalate liquid & gel plus SnF2 paste | Other | Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied Receives: Device: Potassium oxalate; Drug: Stannous fluoride paste |
| oxalate liquid & gel plus NaF paste | Other | Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied Receives: Device: Potassium oxalate; Drug: Sodium fluoride paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Air Challenge
The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows: 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subjects responds to stimulus and requests discontinuation or moves from stimulus, 3: tooth/subject responds to stimulus considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.
Measured: 60 days
Secondary outcomes (1)
Change From Baseline Visual Analog Scale
Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 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, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chad J Anderson, MS, DMD, Principal investigator, Chad J Anderson DMD Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221349
- Sponsor's protocol ID
- 2014069
- Status last verified
- Sep 2020
- First submitted
- 12 Aug 2014
- Last updated
- 9 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
- ClinicalTrials.gov ID
- NCT02221349
- Acronym / sponsor ID
- 2014069
- Conditions
- Dentin Sensitivity
- Keywords
- Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Posted 9 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxalate liquid & gel plus SnF2 paste | Other | Device: Potassium oxalate, Drug: Stannous fluoride pastePotassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied |
| oxalate liquid & gel plus NaF paste | Other | Device: Potassium oxalate, Drug: Sodium fluoride pastePotassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be at least 18 years of age
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form
- Complete a confidentiality disclosure agreement
- Be in good general health as determined by the Investigator/designee
- Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the air challenge.
Key exclusion criteria (8 listed)
- Self-reported pregnancy or nursing
- Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
- Active treatment of periodontitis
- Fixed facial orthodontic appliances
- A history of kidney stones
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 |
|---|---|---|
| Potassium oxalateProfessionally applied (liquid) and self applied (gel) | Device | oxalate liquid & gel plus NaF paste, oxalate liquid & gel plus SnF2 paste |
| Sodium fluoride pasteAlso: NaF pasteToothpaste used by subject | Drug | oxalate liquid & gel plus NaF paste |
| Stannous fluoride pasteAlso: SnF2 pasteToothpaste used by subject | Drug | oxalate liquid & gel plus SnF2 paste |
Primary outcome
Change From Baseline Air Challenge
Time frame: 60 days
The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows: 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subjects responds to stimulus and requests discontinuation or moves from stimulus, 3: tooth/subject responds to stimulus considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.
1 secondary outcome
Change From Baseline Visual Analog Scale
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- 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.
Chad J Anderson, MS, DMD principal investigator
Chad J Anderson DMD Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potassium oxalate, Sodium fluoride paste and Stannous fluoride paste in people with Dentin Sensitivity, run by Procter and Gamble 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 8 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 9 Sep 2020. 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 9 Sep 2020). 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?
Change From Baseline Air Challenge (time frame: 60 days). 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 9 Sep 2020.