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

NCT ID: NCT04898465

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-26

Study Completion Date

2024-01-01

Brief Summary

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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

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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).

Conditions

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Dental Caries Child Neglect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Social Paediatric Intervention

Multiprofessional social paediatric meeting with the family.

Group Type EXPERIMENTAL

Social Paediatric Intervention

Intervention Type OTHER

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.

Control group

Normal post-DGA dental programme.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Heikki Alapulli

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eeva Nikkola, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Consultant

Locations

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New Children's Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 25512015 (View on PubMed)

Other Identifiers

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HUS/180/220

Identifier Type: -

Identifier Source: org_study_id

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