Improving Family's Adherence to Dental Care After DGA (HECC-CAN-study) (HECC-CAN)
Primary Purpose
Dental Caries, Child Neglect
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Social Paediatric Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
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
Sites / Locations
- New Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Social Paediatric Intervention
Control group
Arm Description
Multiprofessional social paediatric meeting with the family.
Normal post-DGA dental programme.
Outcomes
Primary Outcome Measures
Number of uncancelled dental appointments after DGA
Amount of unused or uncancelled dental appointment times after DGA
Secondary Outcome Measures
Number of new decayed teeth after DGA
Amount of caries lesions observed after DGA
Full Information
NCT ID
NCT04898465
First Posted
May 3, 2021
Last Updated
August 2, 2022
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04898465
Brief Title
Improving Family's Adherence to Dental Care After DGA (HECC-CAN-study)
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Child Neglect
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Social Paediatric Intervention
Arm Type
Experimental
Arm Description
Multiprofessional social paediatric meeting with the family.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Normal post-DGA dental programme.
Intervention Type
Other
Intervention Name(s)
Social Paediatric Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of uncancelled dental appointments after DGA
Description
Amount of unused or uncancelled dental appointment times after DGA
Time Frame
0-18 months after the DGA
Secondary Outcome Measure Information:
Title
Number of new decayed teeth after DGA
Description
Amount of caries lesions observed after DGA
Time Frame
0-18 months after the DGA
10. Eligibility
Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heikki Alapulli, DDS
Phone
+358504270345
Email
heikki.alapulli@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eeva Nikkola, MD, PhD
Organizational Affiliation
Consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Children's Hospital
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heikki Alapulli, DDS
Phone
+358504270345
Email
heikki.alapulli@hus.fi
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25512015
Citation
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.
Results Reference
result
Learn more about this trial
Improving Family's Adherence to Dental Care After DGA (HECC-CAN-study)
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