Abstract
BackgroundXylitol 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.MethodsThe 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.DiscussionThis 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 registrationClinical trials.govNCT04420780. Registered on June 9, 2020
Highlights
Ladakh is a region administered by India, covering an area slightly larger than Croatia; it is part of the larger region of Kashmir and Jammu, which has been the subject of dispute between India, Pakistan and China since1947
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)
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 after further 12 months (t3) (24 months from the end of the chewing gum use)
Summary
This is the third and final version of the protocol (edited on the 15th of May 2021). The study will have a triple-blind design: children, parents/guardians and teachers responsible for the treatment; dentists who will evaluate the outcomes; and the statistician who will analyse data will be blinded to the allocation group of the participants. Plans to promote participant retention and completion of follow-ups will be performed; a list of any outcome in participants who discontinue the treatment will be compiled and the data will be analysed, taking into account that living conditions in Ladakh do not allow for high mobility of the population. This will make participant retention a minor problem. A full report of the findings will be prepared and submitted in full length through national and international journals and newsletters and via website
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