Improving Family's Adherence to Dental Care After DGA (HECC-CAN-study)

Dental Caries Clinical Trial

— HECC-CAN  

Official title:

Improving Family's Adherence to Dental Care After Dental General Anaesthesia (DGA). Helsinki Early Childhood Caries - Child Abuse and Neglect-study. (HECC-CAN)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04898465
• Other study ID #: HUS/180/220
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 child's 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 child's DGA can increase the adherence to post-DGA dental care. The secondary aim is to compare its possible influence on children's 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.

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 0.05, beta 0.2, power 0.8).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• reason for DGA is dental caries

• place of birth is Finland

• primary dentition

Exclusion Criteria:

• chronic disease which needs treatment in tertiary hospital

Related Conditions & MeSH terms

• Child Neglect
• Dental Caries

Intervention

Other:
• Social Paediatric Intervention
Family will meet the hospital's social-paediatrician and social worker. Together they will evaluate the need for social support, risk for neglect and refer families for local social services if needed. The visit will contain primary and secondary prophylaxis of child abuse and neglect.

Locations

Country	Name	City	State
Finland	New Children's Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Savanheimo N, Vehkalahti MM. Five-year follow-up of children receiving comprehensive dental care under general anesthesia. BMC Oral Health. 2014 Dec 15;14:154. doi: 10.1186/1472-6831-14-154. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of uncancelled dental appointments after DGA	Amount of unused or uncancelled dental appointment times after DGA	0-18 months after the DGA
Secondary	Number of new decayed teeth after DGA	Amount of caries lesions observed after DGA	0-18 months after the DGA