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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Germany
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Goettingen, Germany
      • Hildesheim, Lower Saxony, Germany, 31141
        • Cognitive Neuroscience Lab, Institute of Psychology, University of Hildesheim Hildesheim, Germany

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Dentistry students
Dentistry students of the University of Göttingen
Psychology students
Psychology students of the University of Hildesheim

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
3 sec

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
300 msec
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
2 sec
Are the pictures different in valence, arousal, attractiveness
Time Frame: 30 min

Questionnaire:

  1. How pleasant this stimulus is for you? (9 point scale: 1 negative - 9 positive)
  2. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Göttingen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stiftung Universität Hildesheim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 8, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 21, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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