- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02899273
Perception of Children With Visible Untreated and Treated Caries (ECC-ET)
April 10, 2019 updated by: Claudia Tschammler, University of Göttingen
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).
Study Overview
Status
Completed
Conditions
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).
Study Type
Observational
Enrollment (Actual)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lower Saxony
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Göttingen, Lower Saxony, Germany, 37075
- Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Goettingen, Germany
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Hildesheim, Lower Saxony, Germany, 31141
- Cognitive Neuroscience Lab, Institute of Psychology, University of Hildesheim Hildesheim, Germany
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
40
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Dentistry students
Dentistry students of the University of Göttingen
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Psychology students
Psychology students of the University of Hildesheim
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The first fixation on one of both pictures will be measured
Time Frame: 3 sec
|
both pictures: a) emotional, b) neutral
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3 sec
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First fixation of one of three areas of interest will be measured
Time Frame: 300 msec
|
areas of interest: a) eyes, b) nose, c) mouth
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300 msec
|
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Fixation time and fixation number of areas of interest will be measured
Time Frame: 2 sec
|
areas of interest: a) eyes, b) nose, c) mouth
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2 sec
|
|
Are the pictures different in valence, arousal, attractiveness
Time Frame: 30 min
|
Questionnaire:
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30 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Annette Wiegand, Prof. Dr., Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany
- Study Chair: Kristian Folta-Schoofs, Prof. Dr., Dep. of Psychology, Stiftung Universität Hildesheim, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
December 8, 2016
Study Completion (Actual)
February 21, 2017
Study Registration Dates
First Submitted
August 26, 2016
First Submitted That Met QC Criteria
September 8, 2016
First Posted (Estimate)
September 14, 2016
Study Record Updates
Last Update Posted (Actual)
April 11, 2019
Last Update Submitted That Met QC Criteria
April 10, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36/2/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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