Although dentally treated children showed improvements in WAZ, HAZ and BAZ while there were deteriorations in WAZ and BAZ and smaller improvements in HAZ in controls, the differences were not statistically significant. There was a statistically significant reduction in dental pain and dental sepsis and improvement in satisfaction with teeth and smile and child’s appetite in treated children compared to controls. This is the first RCT reporting changes in the abovementioned dental and quality of life outcomes from both children’s and parent’s points of view. Previous studies depended solely on parent’s responses
A novel aspect of this study is the design that adequately addressed ethical and methodological challenges involved in this research. One ethical concern was how to find and recruit children for the RCT as some would not receive dental treatment immediately after recruitment. It is deemed unethical to recruit children from emergency dental rooms or children attending regular dental treatment and delaying dental treatment for them if they were assigned to the control group. In addition, children seeking dental treatment would have higher dental functional limitations compared to children attending schools and may need urgent dental treatment. In the current study, children were recruited from their schools and provided with either early or regular dental treatment. No attempts were made to delay dental treatment for the controls. Controls were given direct access to the study dentist if they had a dental emergency; indeed, 31% of them received emergency treatment during the study period.
Methodological concerns such as the validity of the weight measures were also considered. To improve the validity of anthropometric measures, all children were weighed at school at the same time of day (7:30 – 8:50 am) and in the same relation to their eating time (before morning break). Second, reproducibility of data was checked by repeating measurements in 12% of the sample. Third, the new WHO growth references were used as they are valid worldwide, irrespective of ethnicity and socio-economic status
]. Fourth, time difference between baseline and follow-up measurements was minimal between groups to ensure the validity of the measurements and to increase the accuracy of the growth rates comparison.
The comparison of the present study with other studies on the relationship between caries and anthropometric outcomes presents certain difficulties. First, previous studies selected their samples from hospitals, not from a community-based population
]. Recruiting young children from hospitals suggests they had high dental impacts that may be combined with high functional limitations. In this Saudi study, children were recruited from schools. Few children had functional limitations that prevented them from eating or sleeping. Second, a control group was only used in two studies that reported conflicting results
]. The frequently quoted Acs’s study
] used non-randomly assigned caries-free children as controls. The weight percentiles of test children were significantly lower than that of caries-free controls at baseline. This indicates that test and control groups were not comparable at baseline. In fact, 13% of children in the test group in the Acs study satisfied the failure to thrive criteria as they had very low weight measures. The findings of the present study are in agreement with van Gemert-Schriks’s randomized controlled study that reported insignificant changes in mean anthropometric outcomes of dentally treated children compared to untreated controls.
After treatment, children reported significantly lower levels of dental pain and dissatisfaction with teeth and smile than untreated controls; findings consistent with previous non-random studies. Treated children also had no sepsis compared to untreated controls. This is in agreement with findings from a British study
], where the risk of dental sepsis increased with number of untreated carious teeth. In addition, treated children had a significantly increased likelihood of having improved appetite compared to untreated controls. As this study was a community-based RCT with a very high retention rate, assessors were blinded to group identity and selection criteria were restricted to ensure homogeneity and all measures were standardized and reliable, it appears that a real change occurred in the secondary health outcomes due to the dental intervention. Study results are generalizable to healthy children with severe dental caries and without severe functional limitations. Generalizability of this study is enhanced by the community-based sampling.
The study has some limitations. First, the follow-up period was only 6 months and incorporated a single follow-up point, which may not be entirely representative of the pattern of growth changes in children aged six and seven. More importantly, this short-term follow-up period may partly explain the lack of differences between test and control groups in terms of anthropometric outcomes. Significant differences between the groups may have been observed if a longer follow-up period was possible as the direction of change in anthropometric outcomes was in line with the hypothesis. This suggestion is supported by the observed significant differences between treated and untreated groups in other outcomes such as elimination of pain and sepsis and increased appetite that could be viewed as the more immediate effects of the intervention. It seems reasonable to assume that these improvements might precede improvement in children’s growth. However, delaying dental treatment of controls beyond six months was regarded as unethical, because control children had severe dental caries and their treatment could not be delayed to accommodate the ideal requirements for our study. Second, the power of the study can be questioned. The calculation of the sample size may not be appropriate as the estimation of the required number was calculated using expert opinion and an uncontrolled study in an industrialized country. Nevertheless, the fact that a difference was detected in all subjective secondary outcomes suggests that the RCT is robust enough to detect differences. Third, complete blinding of the trial was not feasible. Blinding of data collectors was implemented to avoid bias due to different assessments of the outcomes.