Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05110534 |
| Other study ID # |
BB 078/17 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2017 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
November 2021 |
| Source |
University Medicine Greifswald |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Early childhood caries is a persistent problem often leading to dental treatment under
general anaesthesia (GA). Thus, this study was to investigate the preventive effect of two
additional intensive oral hygiene appointments before and after general anaesthesia.
In this randomized, controlled clinical trial, 408 children (age 2-5 years, mean 4.2+-1.04)
intended for general anaesthesia were recruited and randomly assigned to the intervention and
control groups with or without two additional intensive oral hygiene appointments before and
after the general anaesthesia. At baseline and at 6-/12-month follow-ups, Approximal Plaque
Index (API), gingiva Sulcus Bleeding Index (SBI), caries and initial caries index: initial,
decayed, missing, filled, teeth (idmft) were recorded.
Description:
Early Childhood Caries (ECC) is considered to be a global problem, as it is one of the most
prevalent diseases in childhood. This leads to a severe problem in the caries risk children
being highly affected by ECC, mostly also non-cooperative and from lower socio-economic
background. The dental treatment for these pre-school children often requires general
anaesthesia (GA), which is associated with health risks and considerable costs.
Thus, this study was to investigate the preventive effect of two additional intensive oral
hygiene appointments before and after general anaesthesia.
After approval by the Ethics Committee at the University of Greifswald (No. BB 078/17),
children with an age range from 2 to 5 years assigned for dental treatment under general
anaesthesia were recruited.
After obtaining informed consent from the parents, the participants were randomly allocated
to the test and control groups by a computer-generated random sequence prepared by a
statistician, blinded to the recruiting person. Both groups received a baseline examination
and the standard preventive program offered within the German National Health System
consisting of explaining the etiology of caries and preventive approaches such as practical
training of the parents in tooth brushing in their child as well as recommending fluoridated
toothpaste and a reduction of cariogenic snacks. Finally fluoride varnish was applied. The
test group received two additional preventive sessions including oral hygiene instructions
using plaque disclosing agent, toothbrushing and fluoride application, one week before the
date of the general anaesthesia treatment and at the control visit about a week after the
general anaesthesia.
The baseline and follow-up examinations at 6 and 12 months recorded caries, fillings and
missing teeth due to caries according to the World Health Organisation (WHO) criteria and it
included initial caries lesions according to International Caries Detection and Assessment
System (ICDAS 1-3). The subcomponents were also added up as initial, decayed, missing,
filled, teeth/surfaces (idmft/idmfs). Due to the young age of the children, only primary
teeth were of relevance.
In addition, the Approximal Plaque Index (API) and the gingiva Sulcus Bleeding Index (SBI)
were taken. The examiners were blinded regarding the group status of the children, as other
practice personal had to perform the preventive sessions.
Sample size calculation and statistical analyses:
The expected difference in new caries lesions between test and control groups was taken as an
outcome parameter for sample size calculation. Previous regional studies had shown a mean
caries development of 2 +-1.5 per year after the general anaesthesia. An intensive prevention
program may result in a caries reduction of 30%, corresponding to 0.5-0.6 dmft less in the
test group. With α being 0.05 and a power β of 0.80, 142 children were needed in each group,
with a drop-out of 30% (62 children) this would mean a total sample size of 408 children at
baseline.
The collected data were entered in Excel (Microsoft, USA), then transferred to Stata (Version
14.2; Stata Corp, College Station, USA) for further statistical analysis. Due to the large
sample size and the randomization matching or data linkage analysis were not required, but a
drop-out analysis was carried out to exclude a bias caused by attrition within the study. A
modelling of continuous variables was carried out using restricted cubic splines. Mixed
models were used for adjusting the analyses of changes within every group between baseline
and recalls and between the two groups. Linear models were used for calculating the absolute
effect and ordinal logistic regression for calculating the relative effect via odds ratios.
