ArticleTrials2021
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.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04420780 (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), which is not on this map. Not yet cited in PubMed.
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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
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6 authors at 4 institutions in 4 countries.
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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 (t 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 registrationClinical trials.gov NCT04420780 . Registered on June 9, 2020.
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