NCT02929043

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

January 8, 2016

Last Update Submit

October 25, 2017

Conditions

Dentine Hypersensitivity

Outcome Measures

Primary Outcomes (2)

  • 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

  • blood oxygenation level dependent (BOLD) response

    Changes in blood oxygenation level (indirect measure of neural activity) will be recorded

    October 1, 2016

Study Arms (1)

Dentine hypersensitivity subjects

Other: air puffs

Interventions

air puffsOTHER
Dentine hypersensitivity subjects

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Dentine hypersensitivity (DH) is characterized by a short, sharp pain arising from exposed dentin.

You may qualify if:

  • Age and between 18 - 60

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich, Center of Dental Medicine

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Dominik Ettlin, MD,DMD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2016

First Posted

October 10, 2016

Study Start

July 1, 2015

Primary Completion

April 30, 2016

Study Completion

June 30, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

Locations

CH(1)