Psychophysical Characterization and Brain Correlates of D... | NCT02929043

Studies
Psychophysical Characterization and Brain Correlates of Dentine Hypersensitivity

NCT02929043

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Oct 27, 2017Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Dentine Hypersensitivity

Interventions

air puffs

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Apr 30, 2016Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Jan 8, 2016

First Submission Date that Met QC Criteria

Oct 7, 2016

First Posted Date

Oct 10, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2017

Last Update Posted Date

Oct 27, 2017Actual

Name	Class
GlaxoSmithKline	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
Dentine hypersensitivity subjects			Other: air puffs

Name	Type	Description	Arm Group Labels	Other Names
air puffs	Other		Dentine hypersensitivity subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominik Ettlin, MD,DMD	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Zurich, Center of Dental Medicine		Zurich		8032	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003807	Dentin Sensitivity

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided