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

September 30, 2024 updated by: My Blomqvist

Improved Oral Health in Children with Congenital Heart Disease - an Educational Intervention Trial to Maintain Good Oral Health and Dental Care in Children with Congenital Heart Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Power analysis:

Children with CHD are at high risk of developing caries (Stecksén-Blicks C et al 2004). In Swedish high-risk areas for developing caries, 12 % of three-year-old children had moderate and severe carious lesions (ICDAS II 3-6) and 11% initial carious lesions (ICDAS II 1-2) (Anderson et al 2016). Based on the assumption that 10% in the intervention group and 30% in the control group will develop caries (ICDAS II 1-6), p<0.05 and power 0.80, a sample size of at least 65 individuals in each age group is required. 1.7.2017-31.12.2021 198 Finnish speaking families will be offered to participate in the study. To secure an even distribution block randomization will be used. The patients will be randomized into blocks of 4 and 8, with the help of www.randomization.com (Pandis et al 2011).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CHD intervention
educational intervention using motivational interviewing
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.
No Intervention: CHD control
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.
No Intervention: Healthy control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Caries
Time Frame: 36 months of age
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
Time Frame: 36 months of age
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
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Developmental defects of the enamel
Time Frame: 36 months of age
During a clinical dental examination, developmental defects of the enamel will be registered clinically according to the modified DDE index (Fédération Dentaire Internationale 1992). The Modified Developmental Defects of Enamel Index (Modified DDE Index) is used to diagnose and classify changes in the enamel of the deciduous teeth studied. Three surfaces are examined: buccal, occlusal/incisal and lingual/palatal of all deciduous teeth. The enamel defects are assessed according to three clinical aspects: hypoplasia of the enamel (3 types), diffuse opacities (4 types) and demarcated opacities (2 types). The extent of the affected area is registered in three grades. Number of teeth affected (n) in one patient is then counted.
36 months of age
Orofacial dysfunction
Time Frame: 36 months of age
Orofacial dysfunction, such as difficulties to speak, chew, or swallow, is screened for using The Nordic Orofacial Test - Screening (NOT-S). NOT-S consist of a structured interview and a clinical examination where an illustrated manual is to be used. The NOT-S interview contains six domains: sensory function, breathing, habits, chewing and swallowing, drooling, and dryness of the mouth (I-VI). NOT-S examination contains six domains representing: face at rest, and tasks regarding nose breathing, facial expression, masticatory muscle and jaw function, oral motor function, and speech (1-6). One or more "yes" for impairment in a domain results in one point (maximum NOT-S score 12 points). Normal data for children typically vary between 0 and 4, with a higher value indicating more orofacial dysfunction. The NOT-S test situation will be video recorded, and the analysis will be done by a blinded speech therapist.
36 months of age
Dental fear
Time Frame: 36 months of age

Dental anxiety in the child will be measured by Children's' Fear Survey Schedule-Dental subscale (CFFS-DS). The CFSS-DS questionnaire covers different aspects of dental and medical treatment situations and consists of 15 items. The response to each question is a score from 1 (not afraid) to 5 (very afraid), with a total score varying between 15 and 75. Children with a CFSS-DS score of more than or equal to 38 are defined as dentally anxious.

Parental dental anxiety will be measured by the Modified Dental Anxiety Scale (MDAS). MDAS comprises five multiple-choice questions addressing the individual's reactions and expectations of going to and being treated by a dentist. Each question consists of 5 response alternatives ranging from 1 (no anxiety) to 5 (extreme anxiety) with a total score varying between 5 and 25. A MDAS score of 19-25 indicates high dental anxiety.
36 months of age
Oral health related quality of life (OHRQoL)
Time Frame: 36 months of age

The Parental- Caregivers Perception Questionnaire (P-CPQ) is used to measure he child's oral health related quality of life (OHRQoL), and has the following domains: Oral symptoms (7 items), Functional limitations (7 items), Emotional well-being (9 items) and Social well- being (10 items). Each question has 5 response options (0-4). Total score range 0-124. Scores for domains can be computed separately. A higher score indicates a greater negative OHRQoL of the child.

The Family Impact Scale (FIS) is used to measure the effect of the child's oral health on the family. The FIS consists 12 items divided into three subscales: parental/family activity (5 items), parental emotions (3 items) and family conflict (4 items), and 2 global questions concerning oral health and general well-being. Each question has 5 response options (0-4). Total FIS score range 0-56, where a higher score denotes greater impact of a child's oral condition on family QoL.
36 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
My Blomqvist

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: My Blomqvist, PhD, Department of Oral and Maxillofacial Diseases, Helsinki University Central Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ORALPEDHEART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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