The Effect of Oral Probiotics Containing Streptococcus Salivarius M18 on Gingivitis and Oral Hygiene: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness
研究概览
简要总结
The aim of the study is to assess the effect of oral probiotics containing Streptococcus salivarius M18 on gingivitis and oral hygiene in young adults.
详细描述
This will be a double-blind, randomized, placebo-controlled two-arm parallel-group study of the effect of oral probiotics containing Streptococcus salivarius M18 on gingivitis and oral hygiene. The groups will include young adults with gingivitis diagnosed clinically. To assess the effect of oral probiotics, the following parameters will be used: gingival index, GI; gingival bleeding index, GBI and oral hygiene level (the Turesky Modification of the Quigley-Hein Plaque Index, TMQHPI).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The allocation concealment will be performed by the use of sealed containers numbered by a "third party" (person, who will not participate in the study). The tablets in the bottles without any titles will be placed in the containers. The tablets in different groups will look similar. The patient on enrollment will receive a container with tablets. Each patient will receive a sealed container with tablets on enrollment. Neither patients nor researchers will be aware of the type of a tablets received by each patient (double blinding).
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-25 years
- •Permanent bite;
- •Presence of more than 20 teeth;
- •Absence of systemic and chronic diseases;
- •The diagnosis of gingivitis stated clinically.
排除标准
- •Presence of mild, moderate or severe chronic periodontitis;
- •Refusal to sign informed consent;
- •Taking supplements and medication containing probiotics or prebiotics 1 months before the study;
- •Taking antibiotics (within 3 months before the study);
- •Allergy to the components of the drugs used in the study;
- •Presence of immunodeficiency, taking immunosuppressants.
- •Use of other hygiene products, immunostimulants and antibacterials, probiotics, prebiotics during the study;
- •Refusal to take a given medication;
- •Failure to attend check-ups.
结局指标
主要结局
Evaluation of gingival inflammation using Gingival Index (GI) by H. Loe and J. Silness
时间窗: 8 weeks after the baseline
GI is used to assess visual symptoms of gingivitis on mesial, distal, vestibular, and oral areas of each scorable tooth (1.6, 1.2, 2.4, 3.6, 3.2, 4.4). Each area is given a score from 0 to 3. Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-3). Scoring is performed using standard dental light: 0 = absence of inflammation; 1 = mild inflammation - slight change in color and little change in texture; 2 = moderate inflammation - moderate glazing, redness, oedema, and hypertrophy, bleeding on pressure; 3 = severe inflammation - marked redness and hypertrophy, tendency to spontaneous bleeding, ulceration. Lower scores indicate better results.
Evaluation of gingival inflammation using Gingival bleeding index (GBI) by J. Ainamo and I. Bay, 1975
时间窗: 8 weeks after the baseline
GBI is used to assess bleeding elicited on probing as a measure of gingival condition. Gingivae are air dried and examiner assesses bleeding using a probe which is gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI is assessed on mesial, distal, vestibular, and oral areas of each scorable tooth (whole mouth). Values are presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e., 0-1). BI score:0=no bleeding after 10 sec, 1=bleeding upon probing after 10 sec or immediate bleeding. Lower scores indicate better results.
次要结局
- Evaluation of oral hygiene using Turesky Modification of the Quigley-Hein Plaque Index(8 weeks after the baseline)