Dental CariesECC-ETNCT02899273
Perception of Children With Visible Untreated and Treated Caries
An observational study of Dental Caries, run by University of Göttingen at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- How many people
- 38 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Apr 2016to 21 Feb 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40
Who may be able to join
- healthy
- student of the University of Göttingen or Hildesheim
- age ≥ 18 years
- people who agreed to participate in the study
- right-hander
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Goettingen, Germany
Göttingen, Lower Saxony, 37075
Cognitive Neuroscience Lab, Institute of Psychology, University of Hildesheim Hildesheim, Germany
Hildesheim, Lower Saxony, 31141
About this study
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).
Read the 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).
- Conditions
- Dental Caries
- Keywords
- Early Childhood Caries, eye-tracking, children, dentistry, face perception
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dentistry students | Dentistry students of the University of Göttingen | |
| Psychology students | Psychology students of the University of Hildesheim |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first fixation on one of both pictures will be measured
both pictures: a) emotional, b) neutral
Measured: 3 sec
Secondary outcomes (3)
First fixation of one of three areas of interest will be measured
areas of interest: a) eyes, b) nose, c) mouth
Measured: 300 msec
Fixation time and fixation number of areas of interest will be measured
areas of interest: a) eyes, b) nose, c) mouth
Measured: 2 sec
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
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start1 Apr 2016
- Primary completion8 Dec 2016
- Study completion21 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftung Universität Hildesheim
- Responsible party
- Principal investigator, Claudia Tschammler, University of Göttingen
- Investigators
- Annette Wiegand, Prof. Dr., Study director, Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, GermanyKristian Folta-Schoofs, Prof. Dr., Study chair, Dep. of Psychology, Stiftung Universität Hildesheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899273
- Sponsor's protocol ID
- 36/2/16
- Acronym
- ECC-ET
- Status last verified
- Apr 2019
- First submitted
- 26 Aug 2016
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Children With Visible Untreated and Treated Caries
- ClinicalTrials.gov ID
- NCT02899273
- Acronym / sponsor ID
- ECC-ET / 36/2/16
- Conditions
- Dental Caries
- Keywords
- Early Childhood Caries, eye-tracking, children, dentistry, face perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Collaborators
- Stiftung Universität Hildesheim
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 8 Dec 2016 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dentistry students | – | –Dentistry students of the University of Göttingen |
| Psychology students | – | –Psychology students of the University of Hildesheim |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40
Key inclusion criteria (5 listed)
- healthy
- student of the University of Göttingen or Hildesheim
- age ≥ 18 years
- people who agreed to participate in the study
- right-hander
Key exclusion criteria (8 listed)
- missing agreement to participate in the study
- missing cooperation,
- age < 18 years
- left-hander
- wearer of glasses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The first fixation on one of both pictures will be measured
Time frame: 3 sec
both pictures: a) emotional, b) neutral
3 secondary outcomes
First fixation of one of three areas of interest will be measured
Time frame: 300 msec
Fixation time and fixation number of areas of interest will be measured
Time frame: 2 sec
Are the pictures different in valence, arousal, attractiveness
Time frame: 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Wiegand, Prof. Dr. study director
Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany
Kristian Folta-Schoofs, Prof. Dr. study chair
Dep. of Psychology, Stiftung Universität Hildesheim, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by University of Göttingen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first fixation on one of both pictures will be measured (time frame: 3 sec). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.