Department of Biomedical, Surgical and Dental Sciences, University of Milan, Via Beldiletto 1, 20142, Milan, Italy.
Department of Medicine, Surgery and Experimental Sciences, School of Dentistry, University of Sassari, Viale San Pietro, 07100, Sassari, Italy.
Trials. 2021 Dec 4;22(1):871. doi: 10.1186/s13063-021-05828-y.
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.
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 (t); the clinical examination will be repeated after 12 months since the beginning of the chewing gum administration period (t), after another 12-month period (t) and finally after further 12 months (t) (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.
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.
Clinical trials.gov NCT04420780 . Registered on June 9, 2020.
已有报告显示，木糖醇的使用可以减少牙菌斑和致龋菌的数量，从而降低龋齿的发生率。目前仅有少量关于拉达克地区居民口腔健康的数据。本研究方案的目的是记录居住在拉达克地区的学童的乳牙和恒牙的龋齿患病率，并实施一项基于学校的木糖醇项目，即儿童龋齿预防木糖醇项目（CaPreXCh）试验，使用咀嚼胶。
该方案设计为一项在 5-14 岁儿童中进行的三盲随机、对照、平行组临床试验。该研究原计划于 2021 年 8 月至 2024 年 8 月在赞斯卡河谷（拉达克）进行，但由于 COVID-19 大流行，目前无法对确切的开始时间做出预测。参与者将被随机分配到两组：一组接受含有 70%（重量/体积）木糖醇的咀嚼胶作为唯一甜味剂，另一组接受含有 23%（重量/体积）麦芽糖醇的含糖咀嚼胶。研究对象将被指导在一学年内每天分 3 次（早上 2 次，午餐后 2 次）咀嚼总共 6 粒胶，每次咀嚼 5 分钟。临床检查包括口腔检查，记录龋齿指数（ICDAS 评分）、探诊出血和蔗糖刺激后菌斑 pH 值，基线时（t）记录一次；在咀嚼胶使用期开始后 12 个月（t）、12 个月后（t）和 12 个月后（t）（咀嚼胶使用结束后 24 个月）再次进行临床检查。主要结局指标是在乳牙和恒牙的釉质和牙本质水平上测量的龋齿增量。数据将通过 Kaplan-Meier 图进行分析，以评估龋齿增量。采用共享脆弱性 Cox 回归对方法进行比较。使用 ICDAS（初始龋齿增量、中度龋齿增量和严重龋齿增量，Δ-初始、Δ-中度和 Δ-严重）计算初始、中度和严重龋齿水平的净龋齿增量。
本试验将是在印度进行的第一项评估基于学校的龋齿预防计划通过使用仅含有木糖醇作为甜味剂的咀嚼胶的有效性的试验。研究结果可能有助于为社区为基础的儿童龋齿预防计划中使用木糖醇的有效性提供更多证据。
ClinicalTrials.gov NCT04420780。2020 年 6 月 9 日注册。
