Abstract
Abstract
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.govNCT04420780. Registered on June 9, 2020
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference29 articles.
1. Taneja G, Sridhar VS-R, Mohanty JS, Joshi A, Bhushan P, Jain M, et al. Kumar, Gera RR. India’s RMNCH+A Strategy approach, learnings and limitations. BMJ Glob. Health. 2019;4(3). https://doi.org/10.1136/bmjgh-2018-001162.
2. Miele CH, Schwartz AR, Gilman RH, Pham L, Wise RA, Davila-Roman VG, et al. Increased cardiometabolic risk and worsening hypoxemia at high altitude. High Alt Med Biol. 2016;17(2):93–100. https://doi.org/10.1089/ham.2015.0084.
3. Hirschler V, Molinari C, Gonzalez C, Maccallini G, Castano LA. Prevalence of hypertension in Argentinean indigenous children living at high altitudes versus US children. Clin Exp Hypertens. 2018;40(8):752–7. https://doi.org/10.1080/10641963.2018.1431258.
4. Hirschler V, Gonzalez C, Molinari C, Velez H, Nordera M, Suarez R, et al. Blood pressure level increase with altitude in three Argentinean indigenous communities. AIMS Public Health. 2019;6(4):370–9. https://doi.org/10.3934/publichealth.2019.4.370.
5. Cagetti MG, Cocco F, Calzavara E, Augello D, Zagpoo P, Campus G. Life-conditions and anthropometric variables as risk factors for caries in children in Ladakh. A cross-sectional survey. BMC Oral Health submitted.