Dentinal HypersensitivityNCT02613117
Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity
A study testing Potassium Oxalate Gel, Potassium Oxalate Liquid and Stannous fluoride paste in people with Dentinal Hypersensitivity, run by Procter and Gamble at 1 site in United States.
Trial summary
This study will assess the oral tolerability and immediate post-treatment safety of topical application for two marketed oxalate products as initial care in dental patients to treat or prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentinal Hypersensitivity
- What is being tested?
- Potassium Oxalate Gel, Potassium Oxalate Liquid and Stannous fluoride paste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jun 2016
- 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
- sign an informed consent form and be given a copy
- be in good general health as determined by the Investigator/designee
- agree to not participate in any other oral care study for the duration of this study
- agree to return for scheduled visits and follow all study procedures
- have at least one tooth at risk for hypersensitivity.
Who cannot join
- any medical condition requiring pre-medication prior to dental procedures
- any diseases or conditions that might interfere with the subject safely completing the study
- inability to undergo study procedures
- a history of kidney stones
- have self-reported pregnancy or nursing
- known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, or potassium sorbate
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
This study will assess the oral tolerability and immediate post-treatment safety of topical application for two marketed oxalate products as initial care in dental patients to treat or prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.
- Conditions
- Dentinal Hypersensitivity
- Being tested
- Potassium Oxalate Gel, Potassium Oxalate Liquid, Stannous fluoride paste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium Oxalate GelDevice
Self applied
Potassium Oxalate LiquidDevice
Professionally Applied
Stannous fluoride pasteDrug
SnF2 Paste
| Study group | Role | What they receive |
|---|---|---|
| potassium oxalate gel | Other | potassium oxalate gel self applied Receives: Device: Potassium Oxalate Gel |
| oxalate liquid, SnF2 paste | Other | Potassium oxalate liquid professionally applied, Stannous fluoride paste self applied Receives: Device: Potassium Oxalate Liquid; Drug: Stannous fluoride paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
How Satisfied Were Participants With Treatment?
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Measured: up to 8 weeks
Ease of Treatment at Home
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Measured: Up to 8 weeks
Did Participants Notice a Difference in the Areas Noted?
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2016
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 Dentinal 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613117
- Sponsor's protocol ID
- 2014067
- Status last verified
- Sep 2020
- First submitted
- 13 Nov 2015
- Last updated
- 22 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT02613117
- Acronym / sponsor ID
- 2014067
- Conditions
- Dentinal Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Posted 22 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 assess the oral tolerability and immediate post-treatment safety of topical application for two marketed oxalate products as initial care in dental patients to treat or prevent tooth sensitivity pain that may be attributed to dentinal hypersensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| potassium oxalate gel | Other | Device: Potassium Oxalate Gelpotassium oxalate gel self applied |
| oxalate liquid, SnF2 paste | Other | Device: Potassium Oxalate Liquid, Drug: Stannous fluoride pastePotassium oxalate liquid professionally applied, Stannous 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 (6 listed)
- be at least 18 years of age
- sign an informed consent form and be given a copy
- be in good general health as determined by the Investigator/designee
- agree to not participate in any other oral care study for the duration of this study
- agree to return for scheduled visits and follow all study procedures
Key exclusion criteria (6 listed)
- any medical condition requiring pre-medication prior to dental procedures
- any diseases or conditions that might interfere with the subject safely completing the study
- inability to undergo study procedures
- a history of kidney stones
- have self-reported pregnancy or nursing
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 Oxalate GelSelf applied | Device | potassium oxalate gel |
| Potassium Oxalate LiquidProfessionally Applied | Device | oxalate liquid, SnF2 paste |
| Stannous fluoride pasteSnF2 Paste | Drug | oxalate liquid, SnF2 paste |
Primary outcome
How Satisfied Were Participants With Treatment?
Time frame: up to 8 weeks
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Ease of Treatment at Home
Time frame: Up to 8 weeks
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Did Participants Notice a Difference in the Areas Noted?
Time frame: Up to 8 weeks
Questionnaire indicating the frequencies of using various oral hygiene products by subjects at 5 different dental practices.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gel, Potassium Oxalate Liquid and Stannous fluoride paste in people with Dentinal Hypersensitivity, 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 6 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 22 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 22 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?
How Satisfied Were Participants With Treatment? (time frame: up to 8 weeks). The study lists 3 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 22 Sep 2020.