Improved Oral Health and Dental Care in Children with Congenital Heart Disease

NCT03329170 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-10-02

No results posted yet for this study

Summary

Background: Congenital heart disease (CHD) is one of the most common congenital anomalies in children. As the risk for endocarditis following bacteraemia is more common during daily oral hygiene routines, such as tooth brushing, than during dental treatment, the maintenance of optimal oral health in children with CHD may be considered of outmost importance. Children with CHD have a higher caries prevalence compared to healthy controls.

Aim: The primary aim of the study is to explore if an educational intervention including information, counselling and support provided at early stage to families affected by major CHD, or CHD combined with a syndrome, can increase the awareness of the importance of maintaining of good oral health, and avoid the development of poor oral health including dental caries, leading to less dental anxiety and a higher oral heath related quality of life. The secondary aim is to elucidate factors associated with the development of poor oral health and/or orofacial dysfunction as well as family attitudes and needs of support.

Hypothesis: Early information, counselling and support will lead to a) increased awareness of the importance to maintaining good oral health, b) prevent the development of poor oral health and dental caries, c) lead to less dental fear, and d) lead to higher oral heath related quality of life.

Study design: Randomized educational intervention trial. Study population: Children born in Finland and under 12 months of age in 1.7.2017-31.12.2021 with, a) major CHD and potentially included in the criteria of endocarditis prophylaxis, or b) with a major CHD combined with a chromosomal syndrome, will be offered to participate in the study. Patients will be recruited until 200 patients are obtained at the Helsinki University Children's Hospital. A control group consisting of approximately 100 healthy children will also be recruited at birth.

Main outcomes: Dental caries, dental anxiety, oral health related quality of life, and awareness of importance to maintain and behaviour to maintain good oral health.

Significance: Better information to patients leads to better possibility to achieve good oral health. Better oral health leads to 1) less dental procedures and thereby less dental anxiety, 2) less dental procedures under general anaesthesia, which may potentially be a risk procedure for the child with CHD, and 3) better oral health related quality of life.

Conditions

  • Oral Health
  • Dental Caries

Interventions

BEHAVIORAL

educational intervention using motivational interviewing

A dental hygienist will offer the families verbal and written information regarding oral health and its importance in children with CHD at the cardiac ward, when child is \<12 months. At 6, 12 and 18 months of age, oral health behaviour is assessed via internet, the parents of the child will be sent written information regarding oral health, a tooth brush and a 1000ppm Fluoride tooth paste, after which the dental hygienist will call the parents of the child, to provide additional counselling regarding oral health and its importance in children with CHD. The counselling will be done by motivational interviewing. The themes discussed will be the parents' concerns regarding main points in the written information from the cardiac ward: oral home care, eating habits and dental contact.

Sponsors & Collaborators

  • My Blomqvist

    lead OTHER

Principal Investigators

  • My Blomqvist, PhD · Department of Oral and Maxillofacial Diseases, Helsinki University Central Hospital.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2024-08-31
Completion
2030-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03329170 on ClinicalTrials.gov