Dentin SensitivityNCT02481557
Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis
A study testing Oxalate Salt Solution in people with Dentin Sensitivity, run by Procter and Gamble at 1 site in United States.
Trial summary
This study will assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution. 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?
- Oxalate Salt Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2015
- 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 delay any elective dentistry, and to report any dentistry received during the course of the study
- 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 with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge.
Who cannot join
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
- active treatment for periodontitis
- any diseases or conditions that might interfere with the subject safely completing the study
- inability to undergo study procedures
- fixed orthodontic appliances
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.
- Conditions
- Dentin Sensitivity
- Being tested
- Oxalate Salt Solution
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxalate Salt SolutionDevice
Applied by dentist
| Study group | Role | What they receive |
|---|---|---|
| Oxalate Salt Solution | Experimental | Professionally applied Receives: Device: Oxalate Salt Solution |
| No Treatment | No intervention | No Treatment |
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/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.
Measured: 10 Minutes
Secondary outcomes (1)
Change From Baseline for Yeaple Probe
Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a "yes" response was repeated. If a second "yes" was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive "yes" responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.
Measured: 10 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2015
- Study completionJun 2015
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
- None (open label)
- Enrolment
- 36 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
- NCT02481557
- Sponsor's protocol ID
- 2015069
- Status last verified
- May 2019
- First submitted
- 23 Jun 2015
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis
- ClinicalTrials.gov ID
- NCT02481557
- Acronym / sponsor ID
- 2015069
- Conditions
- Dentin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Posted 29 May 2019
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 sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxalate Salt Solution | Experimental | Device: Oxalate Salt SolutionProfessionally applied |
| No Treatment | No intervention | –No Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 delay any elective dentistry, and to report any dentistry received during the course of the study
- agree to not participate in any other oral care study for the duration of this study
Key exclusion criteria (5 listed)
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
- active treatment for periodontitis
- any diseases or conditions that might interfere with the subject safely completing the study
- inability to undergo study procedures
- fixed orthodontic appliances
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 |
|---|---|---|
| Oxalate Salt SolutionApplied by dentist | Device | Oxalate Salt Solution |
Primary outcome
Change From Baseline Air Challenge
Time frame: 10 Minutes
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/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.
1 secondary outcome
Change From Baseline for Yeaple Probe
Time frame: 10 Minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dentin Sensitivity
Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
Dentin Sensitivity
Active, not recruiting
Clinical Evaluation of Short Dentin Etching
Hypersensitivity Dentin, Dental Restoration Failure of Marginal Integrity
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
Dentine Hypersensitivity Using Dentine Adhesive With Strontium-doped Bioactive Glass-Ceramic
Dentine Hypersensitivity
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 Oxalate Salt Solution 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 7 inclusion and 5 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 11 Jun 2019. 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 29 May 2019). 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: 10 Minutes). 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 11 Jun 2019.