Behavior, ChildNCT04122508
Are Dental Neglect and the Siblings Risk Factors in Children
An observational study of Behavior, Child and Caries,Dental, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Neglect insidiously affects a child's overall health in all aspects. The aim of this study was to determine whether the presence of siblings caused dental neglect, and whether there was a relationship between dental neglect and anxiety. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child, Caries,Dental, Neglect, Child
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 Sep 2019
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children who presented for the first time to the Faculty of Dentistry in Rize
Who may be able to join
- Aged between 6 and 12 years old
- Being healthy
- Being volunteer for the study
Who cannot join
- Systemic and mental disorders
- Syndromes or other major health diseases
- Cooperation problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Training and Research Hospital
Rize, 53100
About this study
Official title: Are Dental Neglect and the Presence of Siblings Risk Factors for Oral Health in Children
Neglect insidiously affects a child's overall health in all aspects. The aim of this study was to determine whether the presence of siblings caused dental neglect, and whether there was a relationship between dental neglect and anxiety.
Read the detailed description
Dental neglect is an intentional failure of parents or caregivers to take precautions and fulfil necessary dental treatment, and has a close relationship with dental caries and anxiety. Oral health status of the children was evaluated using the DMFT/dmft, PUFA/pufa, and OHI-S indices. In addition, the parents completed the Dental Neglect Scale (DNS) and a questionnaire, and the Modified Child Dental Anxiety Scale (MCDASf) was administered to the children to assess their dental anxiety.
- Conditions
- Behavior, Child, Caries,Dental, Neglect, Child, Anxiety
- Keywords
- anxiety, siblings, dental caries, oral health, child abuse
- Medical subject headings
- Child Behavior, Dental Caries, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
the effects of presence of siblings on dental neglect
The effects of presence of siblings on oral health and dental neglect was assessed using dental neglect scale. The dental neglect scale for children was originally composed of seven statements, using a Likert scale ranging from one to five . The total score of DNS can range from 7 to 35, with higher scores representing greater dental neglect.
Measured: for eight months from the beginning of the study
the effects of presence of siblings on oral health
the effects of presence of siblings on oral health and dental neglect was assessed using oral hygiene index . The OHI-S has two elements, the Debris Index and the Calculus Index. The Debris Index and the Calculus Index can range from 0 to 3, the oral hygiene index values from 0 to 6.
Measured: for eight months from the beginning of the study
the effects of presence of siblings on dental caries
the effects of presence of siblings on oral health and dental neglect was assessed using, DMFT/dmft index. caries (D/d), missing due to caries (M/m), filling (F/f) teeth were recorded using DMF-T indices for permanent teeth and dmf-t indices for primary teeth.
Measured: for eight months from the beginning of the study
the effects of presence of siblings on untreated caries
the effects of presence of siblings on oral health and dental neglect was assessed using pufa index. The index recorded the presence of visible pulp involvement (P/p), mucosal ulceration due to root fragments (U/u), fistulae (F/f) and/or abscessess (A/a). Higher scores represents worse oral health.
Measured: for eight months from the beginning of the study
Secondary outcomes (1)
to evaluate whether there was a correlation between dental neglect and anxiety in children
the relationship between dental neglect and anxiety was evaluated using Modified Child Dental Anxiety Scale (MCDASf). MCDASf, which is a validated and reliable indicator for the measurement of dental anxiety in children was used. Children in this study were asked to complete the MCDASf, which covers eight multiple choice statements with five faces ranging from 1 (not anxious), to 5 (extremely anxious). The total score on the MCDASf was calculated for each subject (ranging from 5: little or no dental anxiety, to 40: severe dental anxiety.
Measured: for eight months from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Jan 2019
- Primary completion31 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, ChildStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Aydınoglu, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Sema Aydınoglu, Dr, Principal investigator, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122508
- Sponsor's protocol ID
- 62
- Status last verified
- Oct 2019
- First submitted
- 5 Oct 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Dental Neglect and the Presence of Siblings Risk Factors for Oral Health in Children
- ClinicalTrials.gov ID
- NCT04122508
- Acronym / sponsor ID
- 62
- Conditions
- Behavior, Child, Caries,Dental, Neglect, Child, Anxiety
- Keywords
- anxiety, siblings, dental caries, oral health, child abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 10 Oct 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.
Neglect insidiously affects a child's overall health in all aspects. The aim of this study was to determine whether the presence of siblings caused dental neglect, and whether there was a relationship between dental neglect and anxiety.
Detailed description
Dental neglect is an intentional failure of parents or caregivers to take precautions and fulfil necessary dental treatment, and has a close relationship with dental caries and anxiety. Oral health status of the children was evaluated using the DMFT/dmft, PUFA/pufa, and OHI-S indices. In addition, the parents completed the Dental Neglect Scale (DNS) and a questionnaire, and the Modified Child Dental Anxiety Scale (MCDASf) was administered to the children to assess their dental anxiety.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children who presented for the first time to the Faculty of Dentistry in Rize
Key inclusion criteria (3 listed)
- Aged between 6 and 12 years old
- Being healthy
- Being volunteer for the study
Key exclusion criteria (3 listed)
- Systemic and mental disorders
- Syndromes or other major health diseases
- Cooperation problems
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 effects of presence of siblings on dental neglect
Time frame: for eight months from the beginning of the study
The effects of presence of siblings on oral health and dental neglect was assessed using dental neglect scale. The dental neglect scale for children was originally composed of seven statements, using a Likert scale ranging from one to five . The total score of DNS can range from 7 to 35, with higher scores representing greater dental neglect.
the effects of presence of siblings on oral health
Time frame: for eight months from the beginning of the study
the effects of presence of siblings on oral health and dental neglect was assessed using oral hygiene index . The OHI-S has two elements, the Debris Index and the Calculus Index. The Debris Index and the Calculus Index can range from 0 to 3, the oral hygiene index values from 0 to 6.
the effects of presence of siblings on dental caries
Time frame: for eight months from the beginning of the study
the effects of presence of siblings on oral health and dental neglect was assessed using, DMFT/dmft index. caries (D/d), missing due to caries (M/m), filling (F/f) teeth were recorded using DMF-T indices for permanent teeth and dmf-t indices for primary teeth.
the effects of presence of siblings on untreated caries
Time frame: for eight months from the beginning of the study
the effects of presence of siblings on oral health and dental neglect was assessed using pufa index. The index recorded the presence of visible pulp involvement (P/p), mucosal ulceration due to root fragments (U/u), fistulae (F/f) and/or abscessess (A/a). Higher scores represents worse oral health.
1 secondary outcome
to evaluate whether there was a correlation between dental neglect and anxiety in children
Time frame: for eight months from the beginning of the study
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 Oct 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
Related trials for Behavior, Child
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
Study of Psychoeducation and Reading for Kids (SPARK)
Reading Difficulties, Behavioral Problems
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.
Sema Aydınoglu, Dr principal investigator
Recep Tayyip Erdogan University Training and Research Hospital
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 Behavior, Child and Caries,Dental, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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 Oct 2019. 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 Turkey (Türkiye). 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 effects of presence of siblings on dental neglect (time frame: for eight months from the beginning of the study). 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 11 Oct 2019.