NCT06751979招募中不适用
Effect of the Probiotic Strain Streptococcus Salivarius M18 on de Novo Formation and Composition of Dental Biofilm in Orthodontic Patients: A Randomized Double-blind Placebo-controlled Clinical Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Planimetric plaque quantification
研究概览
简要总结
The purpose of this study is to examine the effect of treatment with a lozenge containing the probiotic strain S. salivarius M18 on the formation, composition and virulence of dental plaque and in healthy orthodontic patients, compared to placebo control.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy males and females ≥ 10 years of age.
- •Able to read and receive a copy of the signed informed consent form.
- •Have at least 20 natural teeth.
- •Have been undergoing orthodontic treatment with fixed orthodontic appliances in the upper and/or lower jaw > 6 months.
- •An average plaque score of > 2 according to the Modified Orthodontic Plaque Index (MOPI) at the screening appointment.
排除标准
- •Significant oral soft tissue pathology based on a visual examination.
- •History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
- •History of allergies to milk proteins.
- •History of allergies towards probiotics.
- •Self-reported as pregnant or nursing.
- •Self-reported serious medical conditions.
- •Antibiotic or anti-inflammatory medication within 30 days of screening visit.
- •Acute sinusitis or severe oral-pharyngeal infections.
研究组 & 干预措施
Probiotic
Active Comparator
干预措施: Probiotic treatment (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Planimetric plaque quantification
时间窗: 6 weeks
Amount of dental plaque formed after 6 weeks of probiotic treatment
次要结局
- Prevalence of S. salivarius(Immediately after intervention)
- Gingivitis(Immediately after intervention)
- Plaque pH(Immediately after intervention)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
The Effect of Probiotics on GingivitisChronic GingivitisNCT05727436I.M. Sechenov First Moscow State Medical University61
已完成
不适用
The Effect of Probiotics on Gingivitis: Part 2Chronic GingivitisNCT05919134I.M. Sechenov First Moscow State Medical University60
Unknown
不适用
Probiotics in Children With Early Childhood CariesDietary SupplementNCT03998306Medical University of Warsaw40
已完成
不适用
Effects of a Probiotic on Oral Microbiota and Glycemic Control in Type 2 Diabetics; A Randomized Clinical TrialDiabetes Mellitus,Type 2PeriodontitisNCT04913909Istanbul University70
已完成
不适用
Efficacy of oral probiotics in improving oral hygiene for orthodontic patientscariesenamel demineralizationgingival inflammationhalitosisOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colongingivitisACTRN12615000341527Faculty of Dentistry, University of Otago64