Oral Health Intervention Program for Children With Congenital Heart Defects

NCT03311438 | Completed

• 1 other identifier: 2009/2264
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Children with congenital heart defects (CHD) are reported to have poorer oral health compared with healthy children. The aim of the present study was to evaluate the effect of an intensive oral health care program among children with CHD followed from infancy to the age of five years, by comparing their oral health status at five years with a control group of children with CHD who had not received the program. Methods: In this longitudinal study, children in western Norway with a need for lifelong follow-up due to congenital heart defects were invited to participate (n=119). Children born in 2008-2011 were offered a promotive oral health intervention program from infancy to the age of five years. The outcome measures for evaluating the intervention were dental caries prevalence, dental erosion, plaque index and gingival bleeding index. The data of the intervention group were compared with cross sectional oral health data of five year old controls with CHD born 2005-2007 (already published).

Conditions

Congenital Heart Defect; Dental Caries in Children; Dental Erosion; Dental Plaque; Hypomineralization, Tooth

Outcome Measures

Primary Outcomes (4)

• Dental caries

  Outcome measures for evaluating the effect of the intervention program, assessed at age five years, was dental caries.Caries in the individual is measured as "caries experience" and quantified with decayed, missing or filled teeth (dmft). At the group level, caries prevalence is the proportion of a group that has any level of caries (dmft\> 0).

  Mean age at baseline 22.2 mon, (SD 8.41, range 6 to 35 mon), 39.6 mon (SD 4.6, range 28 to 51 mon) at three years, and 62.7 mon (SD 3.96, range 55 to 76 mon) at five years. For the control group at five years: Mean age 5.25 years (SD 0.34 years).

• Dental erosion

  Outcome measures for evaluating the effect of the intervention program, assessed at age five years, was dental erosion.For dental erosion, a four graded diagnostic system was applied on buccal and palatal surfaces of the primary maxillary anterior teeth (53-63) and the occlusal surfaces of all primary molars. Erosion grade 3 was considered severe and grade 4 very severe. Prevalence of dental erosion close to or into the dentine ( grade 3-4) was the outcome measurement.

  Mean age at baseline 22.2 mon, (SD 8.41, range 6 to 35 mon), 39.6 mon (SD 4.6, range 28 to 51 mon) at three years, and 62.7 mon (SD 3.96, range 55 to 76 mon) at five years. For the control group at five years: Mean age 5.25 years (SD 0.34 years).

• Dental plaque

  Outcome measures for evaluating the effect of the intervention program, assessed at age five years, was plaque index.For dental plaque the plaque index was reported around the marker teeth 55, 51, 65, 75, 71, and 85. The presence of plaque in the four amelo-gingival areas was assessed with a dental probe and absence of debris was recorded as score 0 and presence as score 1.

  Mean age at baseline 22.2 mon, (SD 8.41, range 6 to 35 mon), 39.6 mon (SD 4.6, range 28 to 51 mon) at three years, and 62.7 mon (SD 3.96, range 55 to 76 mon) at five years. For the control group at five years: Mean age 5.25 years (SD 0.34 years).

• Gingival bleeding

  Outcome measures for evaluating the effect of the intervention program, assessed at age five years, was gingival bleeding index (GBI).Gingival bleeding was recorded around the marker teeth 55, 51, 65, 75, 71, and 85 by probing cautiously using a WHO periodontal probe with a 0.5-mm ball tip on six surfaces; mesio-buccal, in the middle of the buccal surface, disto-buccal, mesio-lingual, in the middle of the lingual surface and, disto-lingual. If bleeding occurred within 10 seconds in at least one of the places, the tooth was scored 1 (bleeding), otherwise the tooth was scored 0.

  Mean age at baseline 22.2 mon, (SD 8.41, range 6 to 35 mon), 39.6 mon (SD 4.6, range 28 to 51 mon) at three years, and 62.7 mon (SD 3.96, range 55 to 76 mon) at five years. For the control group at five years: Mean age 5.25 years (SD 0.34 years).

Study Arms (1)

Oral health intervention program

OTHER

Oral Health intervention program: All parents were encouraged to brush their children's teeth twice a day, with adjusted amount of fluoride toothpaste according to age. Additional fluoride tablets with dose according to age were recommended from two years of age. The children's parents were given written information about the importance and benefits of optimal oral hygiene and explaining the link to infective endocarditis. A pamphlet, lift the lip program, with instruction of looking for early signs of tooth decay, how to intervene and contact local Public Dental Service (PDS) clinic. Dietary advice was also given. The child's responsible dentist or dental hygienist at the local PDS was contacted with information about the project and the findings from examination.

Other: Oral health intervention program

Interventions

Oral health intervention program OTHER

Intervention: All parents were encouraged to brush their children's teeth twice a day, with adjusted amount of fluoride toothpaste according to age. Additional fluoride tablets with dose according to age were recommended from two years of age. The children's parents were given written information about the importance and benefits of optimal oral hygiene and explaining the link to infective endocarditis. A pamphlet, lift the lip program, with instruction of looking for early signs of tooth decay, how to intervene and contact local Public Dental Service (PDS) clinic. Dietary advice was also given. The child's responsible dentist or dental hygienist at the local PDS was contacted with information about the project and the findings from examination.

Oral health intervention program

Eligibility Criteria

• Age: 6 Months - 76 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with congenital heart defects (CHD) in western Norway, born 2008-2011 who require lifelong follow-up for their CHD.

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator

Related Publications (1)

• Sivertsen TB, Astrom AN, Greve G, Assmus J, Skeie MS. Effectiveness of an oral health intervention program for children with congenital heart defects. BMC Oral Health. 2018 Mar 23;18(1):50. doi: 10.1186/s12903-018-0495-5.

  PMID: 29566698 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Tooth Erosion; Dental Plaque; Dental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear; Dental Deposits; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities

Study Officials

• Marit Slåttelid Skeie

  University of Bergen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal study design, promoting oral health among children with congenital heart defects. Oral examination and intervention at baseline (below three years), at first follow-up (three years) and at second follow-up (five years).

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: October 17, 2017
• Study Start: September 1, 2009
• Primary Completion: October 3, 2016
• Study Completion: December 16, 2016
• Last Updated: October 17, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share