Perception of Children With Visible Untreated and Treated... | NCT02899273

Studies
Perception of Children With Visible Untreated and Treated Caries

NCT02899273

Sponsor

University of Göttingen

Status

Completed

Last Update Posted

Apr 11, 2019Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Dental Caries

Interventions

Not provided

Countries

Germany

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

Apr 2019

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

Apr 1, 2016Actual

Primary Completion Date

Dec 8, 2016Actual

Completion Date

Feb 21, 2017Actual

First Submitted Date

Aug 26, 2016

First Submission Date that Met QC Criteria

Sep 8, 2016

First Posted Date

Sep 14, 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

Apr 10, 2019

Last Update Posted Date

Apr 11, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Tschammler, Postdoctoral Research Fellow, University of GöttingenPrincipal Investigator

Lead Sponsor

University of GöttingenOTHER

Collaborators

Name	Class
Stiftung Universität Hildesheim	UNKNOWN

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

In Germany about 5 to 20% of children suffer from early childhood caries (ECC). Preceding results of eye-tracking-studies on the perception of patients with unilateral cleft and patients with severe orthognathic malocclusion let us assume that caries and missing teeth might influence the observer's focus. The aim of this study is to test the hypothesis that the faces of patients with ECC and patients with signs of dental treatment (crown, gap etc.) are contemplated differently from and assessed more negatively than healthy patients. Particular attention should be paid to potential differences between the findings of the two observer-groups (medical laypersons/ dental students).

Detailed Description

In Germany about 5 to 20% of children suffer from early childhood caries (ECC). Resulting in complications like damages of the permanent teeth, pain and developmental disorder of the affected jaw, ECC might additionally lead to social exclusion. Previous eye-tracking-studies about the perception of patients with unilateral cleft and patients with severe orthognathic malocclusion demonstrated that these variations are transferring the observer's focus from the eyes and nose to the affected region. The aim of this study is to test the hypothesis that the faces of patients with ECC and patients with signs of dental treatment (crown, gap etc.) are contemplated differently from and assessed more negatively than healthy patients. Particular attention should be paid to potential differences between the findings of the two observer-groups (medical laypersons/ dental students).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dentistry students		Dentistry students of the University of Göttingen
Psychology students		Psychology students of the University of Hildesheim

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The first fixation on one of both pictures will be measured	both pictures: a) emotional, b) neutral	3 sec

Secondary Outcomes

Measure	Description	Time Frame
First fixation of one of three areas of interest will be measured	areas of interest: a) eyes, b) nose, c) mouth	300 msec
Fixation time and fixation number of areas of interest will be measured

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy
student of the University of Göttingen or Hildesheim
age ≥ 18 years
people who agreed to participate in the study
right-hander

Exclusion Criteria:

missing agreement to participate in the study
missing cooperation,
age < 18 years
left-hander
wearer of glasses
people with severe systemic diseases, especially states with associated temporary or permanent restriction of immune status
people with severe mental illness who have altered perception or neurophysiological stimulus processing.
people who take regularly or at the time of the study drug or drugs that altered a perception or neurophysiological stimulus processing

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annette Wiegand, Prof. Dr.	Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany	Study Director
Kristian Folta-Schoofs, Prof. Dr.	Dep. of Psychology, Stiftung Universität Hildesheim, Germany	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Goettingen, Germany		Göttingen	Lower Saxony	37075	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003731	Dental Caries

Ancestor Terms

ID	Term
D017001	Tooth Demineralization
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided