NCT02899273

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2017

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

August 26, 2016

Last Update Submit

April 10, 2019

Conditions

Keywords

Early Childhood Carieseye-trackingchildrendentistryface perception

Outcome Measures

Primary Outcomes (1)

  • The first fixation on one of both pictures will be measured

    both pictures: a) emotional, b) neutral

    3 sec

Secondary Outcomes (3)

  • First fixation of one of three areas of interest will be measured

    300 msec

  • Fixation time and fixation number of areas of interest will be measured

    2 sec

  • Are the pictures different in valence, arousal, attractiveness

    30 min

Study Arms (2)

Dentistry students

Dentistry students of the University of Göttingen

Psychology students

Psychology students of the University of Hildesheim

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Goettingen, Germany

Göttingen, Lower Saxony, 37075, Germany

Location

Cognitive Neuroscience Lab, Institute of Psychology, University of Hildesheim Hildesheim, Germany

Hildesheim, Lower Saxony, 31141, Germany

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Research Fellow

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 14, 2016

Study Start

April 1, 2016

Primary Completion

December 8, 2016

Study Completion

February 21, 2017

Last Updated

April 11, 2019

Record last verified: 2019-04

Locations