Dentine HypersensitivityNCT02929043
Psychophysical Characterization and Brain Correlates of Dentine Hypersensitivity
An observational study of Dentine Hypersensitivity, run by University of Zurich at 1 site in Switzerland.
Trial summary
Up to date, devices capable of delivering controlled, calibrated, non-contact cold air stimuli in a MR environment are unavailable for quantitative sensory testing. This project therefore aimed at designing and constructing a novel MR-compatible, computer-controlled cold air stimulation device that produces air puffs… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- air puffs
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2015to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Dentine hypersensitivity (DH) is characterized by a short, sharp pain arising from exposed dentin.
Who may be able to join
- Age and between 18 - 60
Who cannot join
- Caries
- Defective restorations
- Full crowns
- Orthodontic bands
- Bleeding on probing and periodontal pockets deeper than 3 mm
- Subjects with gross periodontal disease or treatment of periodontal disease in the past 12 months.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich, Center of Dental Medicine
Zurich, 8032
About this study
Up to date, devices capable of delivering controlled, calibrated, non-contact cold air stimuli in a MR environment are unavailable for quantitative sensory testing. This project therefore aimed at designing and constructing a novel MR-compatible, computer-controlled cold air stimulation device that produces air puffs in a broad flow and cold temperature range. By means of this device, detailed psychophysically testing and subsequent brain scanning of dentine hypersensitivity (DH) subjects will be possible to gain new insights about DH mechanisms.
- Conditions
- Dentine Hypersensitivity
- Being tested
- air puffs
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
air puffsOther
| Study group | Role | What they receive |
|---|---|---|
| Dentine hypersensitivity subjects | Not described Receives: Other: air puffs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective ratings using the BORG scale
individual subject perception ratings will be recorded by means of an adapted BORG scale. For reliability, intraclass correlations will be used covering 3-4 measures within a 3-4-weeks period.
Measured: May 1, 2016
blood oxygenation level dependent (BOLD) response
Changes in blood oxygenation level (indirect measure of neural activity) will be recorded
Measured: October 1, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startJul 2015
- Primary completion30 Apr 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentine HypersensitivityStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Dominik Ettlin, MD,DMD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929043
- Sponsor's protocol ID
- G1
- Status last verified
- Oct 2017
- First submitted
- 8 Jan 2016
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysical Characterization and Brain Correlates of Dentine Hypersensitivity
- ClinicalTrials.gov ID
- NCT02929043
- Acronym / sponsor ID
- G1
- Conditions
- Dentine Hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2015
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to date, devices capable of delivering controlled, calibrated, non-contact cold air stimuli in a MR environment are unavailable for quantitative sensory testing. This project therefore aimed at designing and constructing a novel MR-compatible, computer-controlled cold air stimulation device that produces air puffs in a broad flow and cold temperature range. By means of this device, detailed psychophysically testing and subsequent brain scanning of dentine hypersensitivity (DH) subjects will be possible to gain new insights about DH mechanisms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dentine hypersensitivity subjects | – | Other: air puffs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Dentine hypersensitivity (DH) is characterized by a short, sharp pain arising from exposed dentin.
Key inclusion criteria (1 listed)
- Age and between 18 - 60
Key exclusion criteria (6 listed)
- Caries
- Defective restorations
- Full crowns
- Orthodontic bands
- Bleeding on probing and periodontal pockets deeper than 3 mm
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 |
|---|---|---|
| air puffs | Other | Dentine hypersensitivity subjects |
Primary outcome
Subjective ratings using the BORG scale
Time frame: May 1, 2016
individual subject perception ratings will be recorded by means of an adapted BORG scale. For reliability, intraclass correlations will be used covering 3-4 measures within a 3-4-weeks period.
blood oxygenation level dependent (BOLD) response
Time frame: October 1, 2016
Changes in blood oxygenation level (indirect measure of neural activity) will be recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Individual participant dataSharing planned: Yes
Related trials for Dentine Hypersensitivity
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.
Dominik Ettlin, MD,DMD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dentine Hypersensitivity, run by University of Zurich at 1 site in Switzerland.
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 1 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 27 Oct 2017. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjective ratings using the BORG scale (time frame: May 1, 2016). 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 27 Oct 2017.