Dental Plaque Clinical Trial
Official title:
Evaluation of an Oral Health Intervention Program for Children With Congenital Heart Defects
Verified date | October 2017 |
Source | University of Bergen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 75 |
Est. completion date | December 16, 2016 |
Est. primary completion date | October 3, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 76 Months |
Eligibility |
Inclusion Criteria: Children with congenital heart defects (CHD) in western Norway, born 2008-2011 who require lifelong follow-up for their CHD. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Bergen | Haukeland University Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | |
Primary | 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). | |
Primary | 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). | |
Primary | 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). |
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