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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04933578
Other study ID # 81
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2021
Est. completion date April 5, 2021

Study information

Verified date June 2021
Source Recep Tayyip Erdogan University Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Personal protective equipment (PPE) gained importance during the Coronavirus Disease 2019 (COVID-19) pandemic, which is a global hot topic for all healthcare staff.


Description:

To assess children and parents preferences about dentists' appearance concerning their PPE and to determine the relationship between the preferences of the children and their parents. A total of 250 children aged with 6-12 years and their parents were enrolled in the study. Standardised pictures with different sex, attire, eye protector, hair protector, mask and gloves were shown to children and their parents separately and asked to chose their preferences. Dental anxiety of children and their parents were determined with MCDASf and MDAS, respectively. Decayed-missing-filled teeth (DMFT) index was employed to the children.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date April 5, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - aged 6-12 years and their parents, - intellectually sufficient to complete the questionnaire, - with voluntariness to take part in the study Exclusion Criteria: - had mental or physical disorders, cooperation problems or dental pain

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Dental anxiety scales
The Faces Version of Modified Child Dental Anxiety Scale (MCDASf), which is a psychometric dental anxiety scale for children with eight questions, was used to determine the dental anxiety levels of the children. The scores of each question are represented by varying cartoon faces according to emotions ranging from 1 'relaxed' to 5 'very anxious'. The total scores range from 8 to 40. The scores were categorized as not anxious (>9), slightly anxious (9-16), fairly anxious (17-24), very anxious (25-32), and extremely anxious (33-40). the Modified Dental Anxiety Scale (MDAS) was administered to parents, differently from children. The MDAS has five questions. The scores of each question range from 1 'relaxed' to 5 'very anxious.' The total score ranges from 5 to 25.

Locations

Country Name City State
Turkey Sema Aydinoglu 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 To assess children and parents preferences about dentists' appearance concerning their PPE and to determine the relationship between the preferences of the children and their parents according to dental anxiety levels. Standardised pictures with different sex, attire, eye protector, hair protector, mask and gloves were shown to children and their parents separately and asked to chose their preferences. Dental anxiety of children and their parents were determined with MCDASf and MDAS, respectively. for two months from the beginning of the study
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