Dental Caries in ChildrenNCT03800043
Social Impact of Children's Dental Appearance
An observational study of Dental Caries in Children, run by University of Göttingen at 1 site in Germany.
Trial summary
This study evaluates the social impact of children's dental perception from children with or without caries experience. For this, children and their parents are shown pictures of child faces with healthy teeth, decayed teeth and teeth after dental treatment. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Dental Caries in Children
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2019to 21 Jun 2021
- 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 4 to 9 years
- All sexes
- Child
Study population: children with or without caries experience and their parents
Who may be able to join
- (parent of an child of) age 4-9 years
- sufficient compliance
- dividable into the two groups (with or without caries experience)
Who cannot join
- missing agreement to participate in the study
- insufficient compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center Goettingen, Germany
Göttingen, Lower Saxony, 37075
About this study
This study evaluates the social impact of children's dental perception from children with or without caries experience. For this, children and their parents are shown pictures of child faces with healthy teeth, decayed teeth and teeth after dental treatment.
Read the detailed description
Appearance and abnormalities in the face influences the life of children: attractive children get estimated as more competent and find friends easier than those with a less attractive appearance. Therefore this study aimes to evaluate the social impact of children's dental perception from children with or without own caries experience (and their parents). Both groups (with/without caries experience) are shown pictures of children with different dental status (healthy teeth, decayed teeth and teeth after dental treatment) and asked to complete established questionnaires.The division into the groups is based on photos of the children with visible teeth.
The results should be evaluated descriptively and graphically. Also the comparison between the answers of both groups for the three different dental status is planned.
- Conditions
- Dental Caries in Children
- Keywords
- Early Childhood Caries, children, dentistry, face perception, dental appearance
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 |
|---|---|---|
| Children with own caries experience | Children with own caries experience (visible on a photo; teeth clearly visible), sufficient compliance | |
| Children without own caries experience | Children without own caries experience (visible on a photo; teeth clearly visible), sufficient compliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children: Evaluation of the whole photos
Questionnaire: "How would you feel having a friend looking like this?" (showing the photos of the three different dental status) (4 point face scale of Soares et al. 2015)
Measured: 2-3 minutes
Children: Evaluation of the mouth on the photo
Questionnaire: "How would you feel having a friend with a mouth looking like this" (showing the photos of the three different dental status) (4 point face scale of Soares et al. 2015)
Measured: 2-3 minutes
Children: Evaluation of their own teeth
Questionnaire: "How do you feel when thinking about your own teeth?" (4 point face scale of Soares et al. 2015)
Measured: 1-2 minutes
Why do you feel like this?
Measured: 1-2 minutes
Secondary outcomes (1)
Related parents: Evaluation of the whole photos
Questionnaire: Evaluate the pictures with the adjectives: clever, rude, kind, honest, confident, careful, helpful, stupid, naughty (4 point scale. 'strongly agree' = 4; 'agree' = 3; 'disagree' = 2; 'strongly disagree' = 1)
Measured: 1-2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start15 Jan 2019
- Primary completion31 Jul 2019
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- 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, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800043
- Sponsor's protocol ID
- 25/2/18
- Status last verified
- Jun 2021
- First submitted
- 8 Jan 2019
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Impact of Children's Dental Appearance
- ClinicalTrials.gov ID
- NCT03800043
- Acronym / sponsor ID
- 25/2/18
- Conditions
- Dental Caries in Children
- Keywords
- Early Childhood Caries, children, dentistry, face perception, dental appearance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 10 Jan 2019 (actual)
- 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.
This study evaluates the social impact of children's dental perception from children with or without caries experience. For this, children and their parents are shown pictures of child faces with healthy teeth, decayed teeth and teeth after dental treatment.
Detailed description
Appearance and abnormalities in the face influences the life of children: attractive children get estimated as more competent and find friends easier than those with a less attractive appearance. Therefore this study aimes to evaluate the social impact of children's dental perception from children with or without own caries experience (and their parents). Both groups (with/without caries experience) are shown pictures of children with different dental status (healthy teeth, decayed teeth and teeth after dental treatment) and asked to complete established questionnaires.The division into the groups is based on photos of the children with visible teeth.
The results should be evaluated descriptively and graphically. Also the comparison between the answers of both groups for the three different dental status is planned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with own caries experience | – | –Children with own caries experience (visible on a photo; teeth clearly visible), sufficient compliance |
| Children without own caries experience | – | –Children without own caries experience (visible on a photo; teeth clearly visible), sufficient compliance |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Age groups
- Child
- Study population
- children with or without caries experience and their parents
Key inclusion criteria (3 listed)
- (parent of an child of) age 4-9 years
- sufficient compliance
- dividable into the two groups (with or without caries experience)
Key exclusion criteria (2 listed)
- missing agreement to participate in the study
- insufficient compliance
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
Children: Evaluation of the whole photos
Time frame: 2-3 minutes
Questionnaire: "How would you feel having a friend looking like this?" (showing the photos of the three different dental status) (4 point face scale of Soares et al. 2015)
Children: Evaluation of the mouth on the photo
Time frame: 2-3 minutes
Questionnaire: "How would you feel having a friend with a mouth looking like this" (showing the photos of the three different dental status) (4 point face scale of Soares et al. 2015)
Children: Evaluation of their own teeth
Time frame: 1-2 minutes
Questionnaire: "How do you feel when thinking about your own teeth?" (4 point face scale of Soares et al. 2015)
Why do you feel like this?
Time frame: 1-2 minutes
1 secondary outcome
Related parents: Evaluation of the whole photos
Time frame: 1-2 minutes
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 23 Jun 2021.
- 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
1 site 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 in Children, run by University of Göttingen at 1 site 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 3 inclusion and 2 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 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Children: Evaluation of the whole photos (time frame: 2-3 minutes). The study lists 4 primary outcomes in all. 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 23 Jun 2021.