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Oral Health Intervention Program for Children With Congenital Heart Defects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03311438
Recruitment Status : Completed
First Posted : October 17, 2017
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
University of Bergen

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).


Condition or disease Intervention/treatment Phase
Congenital Heart Defect Dental Caries in Children Dental Erosion Dental Plaque Hypomineralization, Tooth Other: Oral health intervention program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of an Oral Health Intervention Program for Children With Congenital Heart Defects
Actual Study Start Date : September 1, 2009
Actual Primary Completion Date : October 3, 2016
Actual Study Completion Date : December 16, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Oral health intervention program
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
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.




Primary Outcome Measures :
  1. Dental caries [ Time Frame: 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). ]
    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).

  2. Dental erosion [ Time Frame: 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). ]
    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.

  3. Dental plaque [ Time Frame: 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). ]
    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.

  4. Gingival bleeding [ Time Frame: 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). ]
    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.



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Ages Eligible for Study:   6 Months to 76 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311438


Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Investigators
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Study Director: Marit Slåttelid Skeie University of Bergen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Bergen
ClinicalTrials.gov Identifier: NCT03311438    
Other Study ID Numbers: 2009/2264
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Dental Plaque
Tooth Erosion
Tooth Demineralization
Heart Defects, Congenital
Tooth Diseases
Stomatognathic Diseases
Dental Deposits
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Tooth Wear