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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04122508
Other study ID # 62
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date September 30, 2019

Study information

Verified date October 2019
Source Recep Tayyip Erdogan University Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 30, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Locations

Country Name City State
Turkey Recep Tayyip Erdogan University Training and Research Hospital Rize

Sponsors (1)

Lead Sponsor Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. for eight months from the beginning of the study
Primary 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. for eight months from the beginning of the study
Primary 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. for eight months from the beginning of the study
Primary 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. for eight months from the beginning of the study
Secondary 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. for eight months from the beginning of the study
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