Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898465
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2021-05-03
Brief Title:
Improving Familys Adherence to Dental Care After DGA HECC-CAN-study
Sponsor:
Helsinki University Central Hospital
Organization:
Helsinki University Central Hospital
Study Overview
Official Title:
Improving Familys Adherence to Dental Care After Dental General Anaesthesia DGA Helsinki Early Childhood Caries - Child Abuse and Neglect-study HECC-CAN
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HECC-CAN
Brief Summary:
Early childhood caries ECC is a common disease Its prevalence is highest in poor socially disadvantaged and minority groups Dental treatment under General Anaesthesia DGA is common especially among the youngest patients Parental adherence to childs post-DGA dental treatment is varying Non-attendance to preventive care appointments and dental check-ups after the DGA is also common The primary aim of this study is to explore if a multi-professional paediatrician and social worker intervention after the childs DGA can increase the adherence to post-DGA dental care The secondary aim is to compare its possible influence on childrens oral health 18 months after the DGA Our hypothesis is that multi-professional counselling and support after the DGA will lead to better adherence to the scheduled preventive dental programme and better oral health for these children in the long run
Detailed Description:
In an earlier Finnish study 26 of the children did not attend to their first scheduled appointment after the DGA and during a four years follow-up period 63 of the patients had one or more no-shows
Based on the assumption that reducing the amount of no-shows to half of the reported earlier 60 vs 30 is a clinically relevant result we need 42 patients for both groups alpha 005 beta 02 power 08
Based on the assumption that reducing the amount of no-shows to half of the reported earlier 60 vs 30 is a clinically relevant result we need 42 patients for both groups alpha 005 beta 02 power 08
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None