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

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04898465
Collaborator
(none)
100
1
2
48.1
2.1

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Social Paediatric Intervention
N/A

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 0.05, beta 0.2, power 0.8).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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)
Actual Study Start Date :
Feb 26, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Social Paediatric Intervention

Multiprofessional social paediatric meeting with the family.

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.

No Intervention: Control group

Normal post-DGA dental programme.

Outcome Measures

Primary Outcome Measures

  1. Number of uncancelled dental appointments after DGA [0-18 months after the DGA]

    Amount of unused or uncancelled dental appointment times after DGA

Secondary Outcome Measures

  1. Number of new decayed teeth after DGA [0-18 months after the DGA]

    Amount of caries lesions observed after DGA

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 New Children's Hospital Helsinki Finland

Sponsors and Collaborators

  • Helsinki University Central Hospital

Investigators

  • Principal Investigator: Eeva Nikkola, MD, PhD, Consultant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heikki Alapulli, Principal Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT04898465
Other Study ID Numbers:
  • HUS/180/220
First Posted:
May 24, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022