Psychophysical Characterization and Brain Correlates of Dentine Hypersensitivity
October 25, 2017 updated by: University of Zurich
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 Overview
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zurich, Switzerland, 8032
- University of Zurich, Center of Dental Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Dentine hypersensitivity (DH) is characterized by a short, sharp pain arising from exposed dentin.
Description
Inclusion Criteria:
- Age and between 18 - 60
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Dentine hypersensitivity subjects
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Subjective ratings using the BORG scale
Time Frame: May 1, 2016
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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.
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May 1, 2016
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blood oxygenation level dependent (BOLD) response
Time Frame: October 1, 2016
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Changes in blood oxygenation level (indirect measure of neural activity) will be recorded
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October 1, 2016
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dominik Ettlin, MD,DMD, University of Zurich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
April 30, 2016
Study Completion (Actual)
June 30, 2017
Study Registration Dates
First Submitted
January 8, 2016
First Submitted That Met QC Criteria
October 7, 2016
First Posted (Estimate)
October 10, 2016
Study Record Updates
Last Update Posted (Actual)
October 27, 2017
Last Update Submitted That Met QC Criteria
October 25, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.