Dental Caries Clinical Trial
— ECC-ETOfficial title:
Perception of Children With Visible Untreated and Treated Caries
| 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 |
| Verified date | April 2019 |
| Source | University of Göttingen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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).
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University of Göttingen | Stiftung Universität Hildesheim |
Germany,
| 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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