NCT04898465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

May 3, 2021

Last Update Submit

September 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of uncancelled dental appointments after DGA

    Amount of unused or uncancelled dental appointment times after DGA

    0-18 months after the DGA

Secondary Outcomes (1)

  • Number of new decayed teeth after DGA

    0-18 months after the DGA

Study Arms (2)

Social Paediatric Intervention

EXPERIMENTAL

Multiprofessional social paediatric meeting with the family.

Other: Social Paediatric Intervention

Control group

NO INTERVENTION

Normal post-DGA dental programme.

Interventions

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.

Social Paediatric Intervention

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • reason for DGA is dental caries
  • place of birth is Finland
  • primary dentition

You may not qualify if:

  • chronic disease which needs treatment in tertiary hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Children's Hospital

Helsinki, Finland

Location

Related 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.

    PMID: 25512015BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Eeva Nikkola, MD, PhD

    Consultant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 24, 2021

Study Start

February 26, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2024

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations