Efficacy of Two Orally Administered Lactobacillus Reuteri Strains for Gingivitis Reduction in Young Adults: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Gingival index
研究概览
简要总结
The aim of the present study was to investigate the potential beneficial effects in volunteer young adults of orally administered L. reuteri (DSM 17938 and ATCC PTA 5289) on gingival inflammation. The null hypothesis was that no difference would be manifested by probiotic therapy regarding the conventional mechanical treatment (without probiotic administration).
详细描述
Aim. To investigate the potential beneficial effects in volunteer young adults of orally daily administered L. reuteri (DSM 17938 and ATCC PTA 5289) on gingival inflammation. The null hypothesis was that no difference would be manifested by probiotic therapy regarding the conventional mechanical treatment (without probiotic administration).
Methods. A randomized controlled parallel clinical trial was conducted in sixty young adults (18-35 yrs old) with chronic marginal gingivitis for one month. Initially, both study groups underwent conventional mechanical periodontal therapy/oral anti-plaque hygiene. However, the experimental group additionally received the administration of two daily tablets, containing both L. reuteri strains, for 30 days, while the control group did not. Different clinical outcome variables (plaque (PI) and gingival (GI) indices, bleeding on probing (BOP), and crevicular fluid volume (CFV)) were recorded and compared between the study groups, both at baseline and at the end of the interventions, 30 days later. Statistical descriptive and inferential tests were performed (data distribution normality, Student's t, and Wilcoxon-Mann-Whitney tests).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinical evaluators of the results were unaware that each patient belonged to one of the 2 study groups.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smokers (at least for the last 6 months).
- •Initial mean gingival index (GI) between 1.5 -
- •With a minimum of 20 teeth present in the oral cavity.
排除标准
- •Periodontal pockets > 4 mm.
- •Recent intake of antibiotics or anti-inflammatory drugs and/or reception of dental prophylaxis.
- •Daily consumption of analgesics, probiotics, or oral antimicrobial rinses/gels.
- •Overweight (MCI >25).
- •Alcohol or recreative drug frequent consumers.
- •Pregnancy or breast-feeding.
- •Allergy or hypersensitivity to study products
- •Fixed orthodontic appliances.
结局指标
主要结局
Gingival index
时间窗: 0, 7, 14, 21 and 30 days.
The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3, being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
Plaque index
时间窗: 0, 7, 14, 21 and 30 days.
The plaque index assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, except the third molars. The bacterial plaque developer solution was used to define cumulative amounts of plaque with criteria from 0 to 5.
Bleeding on probing
时间窗: 0, 7, 14, 21 and 30 days.
BOP describes bleeding induced by gentle manipulation of the tissue. The probing is typically completed to the depth of the gingival sulcus, or the area between the gingiva and the tooth.
Crevicular fluid volume
时间窗: 0, 7, 14, 21 and 30 days.
Gingival crevicular fluid is an inflammatory exudate derived from the periodontal tissues. It is composed of serum and locally generated materials such as tissue breakdown products, inflammatory mediators, and antibodies directed against dental plaque bacteria.
次要结局
未报告次要终点
研究者
José Arturo Garrocho Rangel
Proffesor/Lecturer/Reasearcher
Universidad Autonoma de San Luis Potosí