Eighty six schoolchildren aged 72 to 95 months with severe dental caries were selected from schoolchildren attending military primary schools and who were therefore eligible for dental treatment at King Fahad Armed Forces Hospital (KFAFH), Jeddah, Saudi Arabia. This population of schoolchildren was selected for the study as they had the highest prevalence of dental caries in Jeddah . All Grade 1 schoolchildren were invited. 417 of 436 children were clinically examined (dental examination and anthropometric measurements) and had face-to-face interviews. 122 of the 417 examined schoolchildren were identified as potentially eligible for the trial and referred to KFAFH for further screening. Only children with severe dental caries were included. Severe dental caries was defined as having at least 2 teeth with pulpal involvement at enrolment. Pulpal involvement was used as a criterion because teeth with infected pulps negatively affect children’s eating and sleeping abilities [14, 15, 19] and are also linked to higher levels of inflammation, which has been shown to affect immunity [20–22], contribute to anaemia  and potentially lead to growth failure [24, 25].
The following groups were excluded; those with illnesses that adversely affect growth; children needing urgent dental treatment; children on regular nutrition supplements and anemic children with hemoglobin levels lower than 11.0 g/dl.
This community-based, randomized trial was undertaken between February 2007 and January 2008. Children were randomly assigned to early (test) or regular (controls) dental treatment. Those in test and control groups received dental treatment according to standard local practices but test children were treated approximately 6-month before controls so that a comparison could be made between treated and untreated children. Simple randomisation was used as eligibility criteria were highly restricted to keep the study subjects more homogenous. The randomisation using tables of random numbers was done between April and May 2007, after screening was completed and was independent of the investigator. Blinding of the treating paedodontist and participants was not feasible given the nature of the study. The design, conduct and reporting of this study complied with the CONSORT (Consolidated Standards of Reporting Trials) statement .
Test children were scheduled for comprehensive dental treatment over a 2-month period (from May to June 2007). Non-restorable grossly decayed teeth and teeth with signs of radiographic pathology and pathological mobility were extracted. Extensive carious lesions such as those with loss of more than two-thirds of the marginal ridge were treated with stainless steel crowns. Teeth with inflamed coronal pulp and healthy radicular pulp tissue were treated by ferric sulphate pulpotomy and crowned with stainless steel crowns. Carious teeth with small lesions with no pulpal involvement were treated with dental fillings.
All test children had their last dental treatment visit in the trial within the last 2 weeks of the second treatment month. At their last visit children were examined to ensure that they were free of dental caries and dental infections. The follow-up survey was scheduled for approximately 6-month after each child’s last dental visit to ensure all children were examined at exactly the same interval between end of treatment and follow-up. Control children did not receive any dental treatment in the period when the test children were treated, unless they had toothache. In that case they were treated for pain by extraction or filling but did not have comprehensive dental treatment. They did receive the same dental treatment as the test group, six months later than the test group.
Outcome measures were assessed at baseline and 6 months post dental intervention. The primary outcome variable was Weight-for-age Z-score (WAZ). Secondary outcomes included Height-for-age Z-score (HAZ), BMI-for-age Z-score (BAZ) , dental pain, dental sepsis, satisfaction with teeth and smile and child’s appetite.
Data collection at baseline for children and their parents followed a standardized protocol. All anthropometric and dental examinations and the face-to-face interviews of the baseline and follow up survey were done at children’s schools, away from the dental surgery, by a trained team who were unaware of the study rationale. Nutritional status was assessed using WHO AnthroPlus software that holds the WHO Reference 2007 for 5-19 years old children . Anthropometric measurements were performed according to the Food and Nutrition Anthropometric Indictors Measurement Guide . Measurements for height and weight were taken to the nearest 0.1 cm and 0.1 kg, respectively. Height was measured with child standing without shoes using a portable Harpenden pocket stadiometer (Chasmors Ltd, London, UK). Weight was measured with the child standing wearing light clothes and not wearing shoes using a pre-calibrated digital Seca scale (Model 767, Hamburg, Germany).
Clinical dental sepsis was defined as “dental abscess presenting as localized swellings or draining sinuses adjacent to carious tooth” . To assess subjective health outcomes, valid questionnaires for both parents and children were used and translated into Arabic. Clarity, suitability and cultural adaptability of the Arabic version of the questions were tested in the pilot study. Children were asked standard questions on pain and satisfaction with teeth and smile [14, 15, 19, 31]. For subjective assessment of appetite, validated questions were answered by parents of children [32, 33]. Reproducibility of data was checked by repeating measurements in 12% of the sample.
The trial was approved, managed and monitored by the Research and Ethics Committee in KFAFH. Monitoring was continued throughout the trial to ensure protocol adherence. Informed consent was obtained from all parents of children.
There have been no published randomized controlled trials on the effect of dental treatment on children’s anthropometric and subjective health outcomes at the time of the trial. The calculation of child’s anthropometric changes was based on weight gain as it needs less follow-up time than height gain . On the basis of available information and expert opinion, it was assumed that the clinical significance was 0.25 Z-score and the common within-group standard deviation estimated to be 0.39. The criterion for significance (alpha) was set at 0.05. With the proposed sample size of 40 for both test and control groups, the study would have power of 80% to yield a statistically significant result. The sample was increased by 10% to account for any deviations in protocol, thus 88 children (44 per group) were enrolled.
All analyses were carried on an intention-to-treat basis. The baseline observation carried forward (BOCF) analysis was used to replace missing data . Characteristics of the two groups were compared using Chi-square or Fisher’s exact test for categorical variables and t tests or Mann–Whitney U test for continuous variables. Categorical outcomes with ordered responses such as child’s appetite, were analyzed using a Chi-square test for trend. Analysis of covariance (ANCOVA) models were used with the baseline assessment score as the covariate. Odds ratios (OR) with 95% Confidence Intervals (CI) were calculated to measure treatment effects for secondary outcomes. To estimate the effect of dental treatment the secondary categorical outcomes were grouped into ordered categories of 1. improved, 2. no change and 3. worsen. SPSS (version 15) was used for all analyses.