NCT06752330已完成不适用
Evaluation of the Effect of a Probiotic in Subjects Undergoing Fixed Orthodontic Appliances With Multibrackets or Clear Aligners: a Single-blind Randomized Controlled Trial
University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Full Mouth Bleeding Score (FMBS)
研究概览
简要总结
Orthodontic patients need supplementary oral hygiene tools in addition to professional oral hygiene. The aim of this study is to evaluate the effects of Bifidobacterium animalis subs. Lactis HN019 on plaque accumulation and gingival bleeding in orthodontic patients.
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
- Single (Investigator)
盲法说明
The operator performing the data collection was unaware of the group membership of the evaluated patient
入排标准
- 年龄范围
- 10 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age range of 10 to 30 years old;
- •good general health;
- •patients undergoing fixed multibracket orthodontic treatment;
- •patients undergoing invisible aligner orthodontic treatment.
排除标准
- •physical, mental or motor disabilities;
- •systemic conditions that influence the progression of gingivitis;
- •presence of non-plaque-induced gingivitis;
- •known allergies;
- •smokers (if more than 5 cigarettes per day);
- •use of antibiotics, anti-inflammatories, or probiotics in the 6 months prior to recruitment.
结局指标
主要结局
Full Mouth Bleeding Score (FMBS)
时间窗: 4 months
FMBS is a dichotomous index indicating the presence of gingival bleeding on 6 surfaces, the same as FMPS, after light probing. The ratio of surfaces with bleeding to the total of the assessed surfaces is presented as a percentage.
次要结局
- Full Mouth Plaque Score (FMPS)(4 months)
研究者
Jacopo Lanzetti
Dental Hygienist
University of Turin, Italy
研究点 (2)
Loading locations...
相似试验
已完成
不适用
The Effect of Oral Probiotics on Oral Hygiene and Halitosis in Orthodontic Patients.HalitosisProbioticsOrthodontic Appliance ComplicationNCT05651503University of Athens120
已完成
不适用
Probiotics as Adjunct to Non Surgical Periodontal Therapy for Pregnant Women Oral HealthPeriodontal DiseasesNCT05400538University of Pavia30
已完成
不适用
Effect of a Probiotic Water on Oral Health in AdultsOral BacteriaHalitosisNCT04473404Dose Biosystems Inc.48
撤回
不适用
Effects of Prebiotic Oral Healthcare Products as an Adjunct to Non-surgical Periodontal TherapyPeriodontitisNCT02520375Universitaire Ziekenhuizen KU Leuven
招募中
2 期
The effect of using probiotics along with orthodontic wax on the pain and ulcers relief in patients undergoing fixed orthodontic treatmentIRCT20230208057356N1Tabriz University of Medical Sciences28