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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02929043
Other study ID # G1
Secondary ID
Status Completed
Phase N/A
First received January 8, 2016
Last updated October 25, 2017
Start date July 2015
Est. completion date June 30, 2017

Study information

Verified date October 2017
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 30, 2017
Est. primary completion date April 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Other:
air puffs


Locations

Country Name City State
Switzerland University of Zurich, Center of Dental Medicine Zurich

Sponsors (2)

Lead Sponsor Collaborator
University of Zurich GlaxoSmithKline

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. May 1, 2016
Primary blood oxygenation level dependent (BOLD) response Changes in blood oxygenation level (indirect measure of neural activity) will be recorded October 1, 2016
See also
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