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

NCT03329170 | Active Not Recruiting

• 1 other identifier: ORALPEDHEART
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral health; Dental caries; Heart Defects; Congenital

Outcome Measures

Primary Outcomes (3)

• Caries

  During a clinical dental examination, caries will be registered clinically according to the ICDAS II (Pitts et al 2013, Shoaib et al 2009). The caries lesions on a tooth surface are graded as "initial" (ICDAS 1-2), "moderate" (ICDAS 3-4) and "extensive" (ICDAS 5-6). The indexes dmfs (decayed, missing or filled surfaces) and dmft (decayed, missing or filled surfaces) will be calculated separately for ICDAS 1-2, ICDAS 3-6 and ICDAS 1-6. The range for dmfs is 0-88 and dmft is 0-20, with 0 indicating no caries, and an increasing number indicating more carious lesions.

  36 months of age

• Dental plaque

  During a clinical dental examination, visible plaque will be registered on the labial surfaces of the maxillary incisors (y/n) as a risk indicator for developing caries (Alaluusua and Malmivirta 1994).

  36 months of age

• Awareness of the importance to maintain good oral heath

  Awareness of the importance to maintain good oral health will be measured with a questionnaire designed to assess adherence to the recommendations in the written information regarding oral health care provided at baseline in the intervention group. The questionnaire includes three domains: tooth brushing, sugar intake, and dental contact. Tooth brushing includes 6 questions (morning, night, parent brushing, problems with brushing, continue brushing though problems, fluoride tooth paste), sugar intake includes 5 questions (frequency of eating, sugary drink, eating during night, sugary food, medicine taken with sugar), and the dental contact includes one question (dental visit). Every answer not in accordance to the recommendations given, is scored with 1 point, giving a range in tooth brushing 0-6, sugar intake 0-5, and dental contact 0-1, with an increasing value indicating less awareness of the importance to maintain good oral health.

  Intervention group at 24 and 36 months of age; CHD control group at 24 and 36 months of age; healthy control group at 24 and 36 months of age.

Secondary Outcomes (4)

• Developmental defects of the enamel

  36 months of age

• Orofacial dysfunction

  36 months of age

• Dental fear

  36 months of age

• Oral health related quality of life (OHRQoL)

  36 months of age

Study Arms (3)

CHD intervention

EXPERIMENTAL

educational intervention using motivational interviewing

Behavioral: educational intervention using motivational interviewing

CHD control

NO INTERVENTION

At 24 and 36 months of age the parents of the child will fill in a questionnaire via internet, designed to assess oral health behaviour. At 36 months of age the child will be offered to participate in a clinical dental examination.

Healthy control

NO INTERVENTION

At 36 months of age the parents of the child will fill in a questionnaire via internet, designed to assess oral health behaviour. At 36 months of age the child will be offered to participate in a clinical dental examination.

Interventions

educational intervention using motivational interviewing BEHAVIORAL

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.

CHD intervention

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age \< 12 months and prostethic cardiac valve or patient likely to undergo valve surgery using foreign material including homograft (potentially included in the criteria of endocarditis prophylaxis)
• Age \< 12 months and unrepaired cyanotic CHD including palliative shunts and conduits
• Age \< 12 months and repaired CHD with residual defects at the site or adjacent to the site of the prosthetic patch or device which inhibits endothelialization
• Age \< 12 months and cardiac transplantation recipient or listed for transplantation (potentially included in the criteria of endocarditis prophylaxis)
• Age \< 12 months and cardiomyopathy (potential cardiac transplantation recipient)
• Age \< 12 months and chromosomal abnormality or syndrome and any invasive intevention (surgery or cath) for CHD or likely to require invasive intervention for CHD

You may not qualify if:

• Neither parent amenable to comprehend intervention instructions provided in Finnish
• Child in out-of-home care (eg foster care)

Sponsors & Collaborators

• My Blomqvist: lead

Study Sites (1)

Department of Pediatrics, Children´s Hospital, Helsinki University Central Hospital.

Helsinki, Finland

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• My Blomqvist, PhD

  Department of Oral and Maxillofacial Diseases, Helsinki University Central Hospital.

  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: SPONSOR INVESTIGATOR
• PI Title: DDS, Specialist in Paediatric Dentistry, PhD

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: November 1, 2017
• Study Start: July 1, 2017
• Primary Completion: August 31, 2024
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)