Dentinal HypersensitivityNCT03405259
A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity
A study testing Super Seal® Desensitizer and Acclean® Fluoride Varnish in people with Dentinal Hypersensitivity, run by Procter and Gamble.
Trial summary
The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment. 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?
- Super Seal® Desensitizer and Acclean® Fluoride Varnish
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2013to 13 Sep 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
- 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;
- be in good general health as determined by the Investigator/designee; and
- have at least one tooth with a VAS score of greater than or equal to 30 in response to the air challenge.
Who cannot join
- allergy to rosin or to pine nuts;
- self-reported pregnancy or nursing;
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- active treatment for periodontitis;
- fixed facial orthodontic appliances;
- any diseases or conditions that might interfere with the safe completion of the study; or
- an inability to undergo any study procedures.
About this study
Official title: A Pilot Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity
The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.
- Conditions
- Dentinal Hypersensitivity
- Being tested
- Super Seal® Desensitizer, Acclean® Fluoride Varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super Seal® DesensitizerDevice
Single dose professional application.
Acclean® Fluoride VarnishDevice
Single dose professional application.
| Study group | Role | What they receive |
|---|---|---|
| Super Seal® Desensitizer | Experimental | Professionally Applied Receives: Device: Super Seal® Desensitizer |
| Acclean® Fluoride Varnish | Sham comparator | Professionally Applied Receives: Device: Acclean® Fluoride Varnish |
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: Within 5 minutes after treatment was applied
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. A negative change from Baseline score represents a decrease in sensitivity from baseline.
Measured: Within 5 minutes after treatment was applied
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start26 Jun 2013
- Primary completion13 Sep 2013
- Study completion13 Sep 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 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
- NCT03405259
- Sponsor's protocol ID
- 2013077
- Status last verified
- Jun 2019
- First submitted
- 12 Jan 2018
- Last updated
- 17 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT03405259
- Acronym / sponsor ID
- 2013077
- Conditions
- Dentinal Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2013 (actual)
- Primary completion
- 13 Sep 2013 (actual)
- Study completion
- 13 Sep 2013 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Posted 17 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super Seal® Desensitizer | Experimental | Device: Super Seal® DesensitizerProfessionally Applied |
| Acclean® Fluoride Varnish | Sham comparator | Device: Acclean® Fluoride VarnishProfessionally Applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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;
- be in good general health as determined by the Investigator/designee; and
- have at least one tooth with a VAS score of greater than or equal to 30 in response to the air challenge.
Key exclusion criteria (7 listed)
- allergy to rosin or to pine nuts;
- self-reported pregnancy or nursing;
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- active treatment for periodontitis;
- fixed facial 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 |
|---|---|---|
| Super Seal® DesensitizerSingle dose professional application. | Device | Super Seal® Desensitizer |
| Acclean® Fluoride VarnishSingle dose professional application. | Device | Acclean® Fluoride Varnish |
Primary outcome
Change From Baseline Air Challenge
Time frame: Within 5 minutes after treatment was applied
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.
Change From Baseline Visual Analog Scale
Time frame: Within 5 minutes after treatment was applied
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. A negative change from Baseline score represents a decrease in sensitivity from baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Super Seal® Desensitizer and Acclean® Fluoride Varnish in people with Dentinal Hypersensitivity, run by Procter and Gamble.
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 4 inclusion and 7 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 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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 17 Jun 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: Within 5 minutes after treatment was applied). 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 17 Jun 2019.