- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04122508
Are Dental Neglect and the Siblings Risk Factors in Children
October 9, 2019 updated by: Sema Aydınoglu, Recep Tayyip Erdogan University Training and Research Hospital
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
100
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
-
-
-
Rize, Turkey, 53100
- Recep Tayyip Erdogan University Training and Research Hospital
-
-
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
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
children who presented for the first time to the Faculty of Dentistry in Rize
Description
Inclusion Criteria:
- Aged between 6 and 12 years old
- Being healthy
- Being volunteer for the study
Exclusion Criteria:
- Systemic and mental disorders
- Syndromes or other major health diseases
- Cooperation problems
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
- Observational Models: Case-Crossover
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
for eight months from the beginning of the study
|
|
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.
|
for eight months from the beginning of the study
|
|
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.
|
for eight months from the beginning of the study
|
|
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.
|
for eight months from the beginning of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
for eight months from the beginning of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sema Aydınoglu, Dr, Recep Tayyip Erdogan University Training and Research Hospital
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)
January 1, 2019
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
October 5, 2019
First Submitted That Met QC Criteria
October 9, 2019
First Posted (Actual)
October 10, 2019
Study Record Updates
Last Update Posted (Actual)
October 11, 2019
Last Update Submitted That Met QC Criteria
October 9, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 62
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available 5 years after publication
IPD Sharing Access Criteria
Data access requests will be reviewed by authors.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States