Study protocol for a randomized clinical trial to evaluate the effect of the use of Xylitol gum in the prevention of caries lesions in children living in Ladakh-the Caries Prevention Xylitol in Children (CaPreXCh) trial.

BACKGROUND: Xylitol use is reported to be able to reduce dental plaque amount and cariogenic bacteria and, as a consequence, the caries increment. Only few data on the oral health of Ladakh's population are available. The aim of the present protocol will be to record the caries prevalence of primary and permanent molars of schoolchildren living in Ladakh and to implement a school-based Xylitol programme, named the Caries Prevention Xylitol in Children (CaPreXCh) trial, using chewing gums. METHODS: The protocol is designed as a triple-blind randomized, controlled, parallel-group clinical trial in children aged 5-14 years. The study should have been carried out from August 2021 to August 2024 in Zanskar Valley (Ladakh), but the COVID-19 pandemic does not allow today to make predictions on the exact start. Participants will be randomly allocated into two groups: subjects who will receive a chewing gum with Xylitol (70% w/v) as only sweetener, and those who will receive a sugared chewing gum containing Maltitol (23% w/v). The subjects will be instructed to chew a total of 6 pellets for 5 min divided into 3 intakes a day (2 in the morning, 2 after the midday meal and 2 in the afternoon) for one school year. Clinical examination will comprise an oral examination in which caries index (ICDAS scores), bleeding on probing and plaque pH evaluation after sucrose challenge will be recorded at baseline (t0); the clinical examination will be repeated after 12 months since the beginning of the chewing gum administration period (t1), after another 12-month period (t2) and finally after further 12 months (t3) (24 months from the end of the chewing gum use). The primary outcome will be the caries increment measured both at enamel and dentinal levels on primary and permanent molars. Data analysis will be conducted through Kaplan-Meyer graphs to evaluate caries increment. A comparison of the methods will be carried out with Cox regression with shared frailty. The net caries increment for initial, moderate and severe caries levels, using ICDAS (Δ-initial, Δ-moderate and Δ-severe), will be calculated. DISCUSSION: This trial will be the first trial conducted in India assessing the efficacy of a school-based caries preventive programme through the use of chewing gum containing only Xylitol as a sweetener. The findings could help strengthen the evidence for the efficacy of Xylitol use in community-based caries prevention programmes in children. TRIAL REGISTRATION: Clinical trials.gov NCT04420780 . Registered on June 9, 2020.

Life-conditions and anthropometric variables as risk factors for oral health in children in Ladakh, a cross-sectional survey.

BACKGROUND: The aim of this survey was to evaluate the severity of dental caries among children living in Zanskar Valley (Ladakh, India) and its association with anthropometric and background variables. METHODS: This cross-sectional survey was conducted on schoolchildren divided into four age groups (< 6, ≥ 6 < 11, ≥ 11 < 14 and > 14 years of age). A total of 1474 schoolchildren (607 males, 41.2%) were examined. Actual caries prevalence (dt/DT) and gingival bleeding were recorded by four calibrated dentists. An ad hoc questionnaire evaluated general health, eating habits, oral hygiene and the self-perception of oral conditions. Height, weight, waist circumference, heart-rate and oxygen-saturation were also collected directly by examiners. Responses to questionnaire items were treated as categorical or ordinal variables. The relationship between children's caries data, gingival bleeding, gender, Body Mass Index (BMI) following the International Obesity Task Force, waist circumference and questionnaire items was assessed using the Kruskal-Wallis test and Pearson correlation. Conditional ordinal logistic regression was used to analyse associations among caries severity, gender, BMI, waist circumference, oxygen saturation and questionnaire items. A forward stepwise logistic regression procedure was also carried-out to estimate the ORs of gingival bleeding prevalence and the covariates derived from examination or questionnaire. RESULTS: Caries was almost ubiquitarian with only 10.0% of caries-free children (dt/DT = 0). Caries severity, in both primary and permanent dentitions, was statistically significantly related to gender, waist circumference, BMI, oral hygiene frequency and self-reported chewing problems (p < 0.01 in both dentitions). An increasing relative risk for caries in permanent dentition compared to caries-free subjects was observed in children with a low BMI (RRR = 1.67, 95%CI = 1.54/2.83 for subjects with 1-3 caries lesions and RRR = 1.52, 95%CI = 1.36/1.74 for subjects with > 3 caries lesions); also, children with reduced waist circumference had a higher relative risk to have 1-3 caries lesions (RRR = 2.16, 95%CI = 1.84/2.53) and an even higher risk to have more than 3 caries lesions (RRR = 4.22, 95%CI = 3.33/5.34). CONCLUSIONS: A significant impact of untreated caries lesions was observed in Ladakh schoolchildren; low BMI values and reduced waist circumference showed to be the main caries risk predictors. Preventive and intervention programmes should be implemented to improve children's oral health.