Effect of Probiotics in Addition to Dental Brushing on Gum Inflammation and Oral Microbiota in Patients With Fixed Orthodontic Appliances
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Variation of gingival index (Löe Silness) between baseline and 6 months
研究概览
简要总结
Gingival inflammation (gingivitis) is commonly reported in teenagers with fixed orthodontic devices (FOD). Indeed, FODs promote the accumulation of plaque and interfere with the efficacy of tooth brushing. According to in vitro and in vivo studies, the administration of oral probiotic bacteria including Lactobacillus reuteri may reduce the number of periodontal pathogens in saliva and dental plaque. A recent systematic review shows a positive effect of probiotics in addition to tooth brushing in the treatment of periodontitis. However, there is insufficient data regarding the effect of probiotics in the prevention of gum diseases. The aim of this double-blind randomized placebo-controlled study is to assess the effect of probiotics, in addition to dental brushing, on gum inflammation and the composition of the oral microbiota in teenagers with fixed orthodontic appliances
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adolescents aged 12 to 16 benefiting from social security coverage
- •in good general health in brushing and taking treatments
- •Have FODs
- •who consent to the study and whose parents have given their consent
- •suitable for orthodontic treatment in view of his oral state
排除标准
- •inability to obtain informed consent
- •use of another probiotic or toothpaste / antiseptic mouthwash ≤ 1 month before inclusion
- •allergy or hypersensibiliity to the active substance or to any of the excipients listed in the Gum® PerioBalance® user guide)
- •no history of antibiotic therapy, antiseptic mouthwash ≤ 1 month before inclusion
- •medical contraindication (immunosuppression, pathology requiring prophylactic antibiotic therapy before dental care)
- •physiological, pathological condition, medication or behavior that may have repercussions on the oral cavity (eg: pregnancy, diabetes, antiepileptics, tobacco)
- •oral state requiring other priority care (untreated cavities, untreated active periodontitis, progressive recession)
研究组 & 干预措施
Experimental group
干预措施: Oral probiotics (L. reuteri) (Dietary Supplement)
control group
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Variation of gingival index (Löe Silness) between baseline and 6 months
时间窗: At 6 months
次要结局
- level of salivary markers of inflammation -(At Baseline, at 3 months and 6 months)
- plaque index (O'leary)(At Baseline, at 3 months and 6 months)
- bleeding on probing (BOP) score (% of BOP sites)(At Baseline, at 3 months and 6 months)
- dysbiosis index(At Baseline, at 3 months and 6 months)
- compliance level record(At Baseline, at 3 months and 6 months)