Dental CariesHECC-CANNCT04898465
Improving Family's Adherence to Dental Care After DGA (HECC-CAN-study)
A study testing Social Paediatric Intervention in people with Dental Caries and Child Neglect, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Dental Caries, Child Neglect
- What is being tested?
- Social Paediatric Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteFinland
- Study dates
- 26 Feb 2021to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- reason for DGA is dental caries
- place of birth is Finland
- primary dentition
Who cannot join
- chronic disease which needs treatment in tertiary hospital
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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).
- Conditions
- Dental Caries, Child Neglect
- Being tested
- Social Paediatric Intervention
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Paediatric InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Social Paediatric Intervention | Experimental | Multiprofessional social paediatric meeting with the family. Receives: Other: Social Paediatric Intervention |
| Control group | No intervention | Normal post-DGA dental programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of uncancelled dental appointments after DGA
Amount of unused or uncancelled dental appointment times after DGA
Measured: 0-18 months after the DGA
Secondary outcomes (1)
Number of new decayed teeth after DGA
Amount of caries lesions observed after DGA
Measured: 0-18 months after the DGA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start26 Feb 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heikki Alapulli, Helsinki University Central Hospital
- Investigators
- Eeva Nikkola, MD, PhD, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898465
- Sponsor's protocol ID
- HUS/180/220
- Acronym
- HECC-CAN
- Status last verified
- Sep 2025
- First submitted
- 3 May 2021
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25512015
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04898465
- Acronym / sponsor ID
- HECC-CAN / HUS/180/220
- Conditions
- Dental Caries, Child Neglect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Paediatric Intervention | Experimental | Other: Social Paediatric InterventionMultiprofessional social paediatric meeting with the family. |
| Control group | No intervention | –Normal post-DGA dental programme. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- reason for DGA is dental caries
- place of birth is Finland
- primary dentition
Key exclusion criteria (1 listed)
- chronic disease which needs treatment in tertiary hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Paediatric InterventionFamily 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. | Other | Social Paediatric Intervention |
Primary outcome
Number of uncancelled dental appointments after DGA
Time frame: 0-18 months after the DGA
Amount of unused or uncancelled dental appointment times after DGA
1 secondary outcome
Number of new decayed teeth after DGA
Time frame: 0-18 months after the DGA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Results publication: PubMed 25512015Savanheimo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eeva Nikkola, MD, PhD principal investigator
Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Paediatric Intervention in people with Dental Caries and Child Neglect, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of uncancelled dental appointments after DGA (time frame: 0-18 months after the DGA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04898465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.