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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02899273
Other study ID # 36/2/16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2016
Est. completion date February 21, 2017

Study information

Verified date April 2019
Source University of Göttingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date February 21, 2017
Est. primary completion date December 8, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Goettingen, Germany Göttingen Lower Saxony
Germany Cognitive Neuroscience Lab, Institute of Psychology, University of Hildesheim Hildesheim, Germany Hildesheim Lower Saxony

Sponsors (2)

Lead Sponsor Collaborator
University of Göttingen Stiftung Universität Hildesheim

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary The first fixation on one of both pictures will be measured both pictures: a) emotional, b) neutral 3 sec
Secondary First fixation of one of three areas of interest will be measured areas of interest: a) eyes, b) nose, c) mouth 300 msec
Secondary Fixation time and fixation number of areas of interest will be measured areas of interest: a) eyes, b) nose, c) mouth 2 sec
Secondary Are the pictures different in valence, arousal, attractiveness Questionnaire:
How pleasant this stimulus is for you? (9 point scale: 1 negative - 9 positive)
How exciting is this stimulus to you? (9 point scale: 1 low - 9 high) 3 How attractive is this appeal to you? (9 point scale: 1 unattractive - 9 attractive) Self-Assessment-Manikin scales
30 min
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