Analysis of the antimicrobial activity of probiotics against oral pathogens on clear aligners using confocal laser scanning microscopy.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Efficacy of different probiotics on biofilm formed around clear aligners
研究概览
简要总结
• Twenty patients will be randomly selected who have opted for orthodontic treatment via clear aligners (Invisalign). Four different types of probiotics in the form of gummies, tablet, rinse and drink will be given to the patient. Dose of each probiotic will be explained to the patient. Each sample will be collected after 1 week from the patient. First week will be taken as a control group. After 1st week new set of aligner will be given for 7 days with probiotic 1 (gummies). After 7 days, old aligners will be taken as a test group. Same procedure will be followed with different probiotics i.e probiotic 2(tablet), probiotic 3(rinse) and probiotic 4(drink). A wash out period of 2 weeks between the two probiotics will be used to prevent mis-interpreting observations. From all the clear aligners, small discs will be punched out using aligner hole punch plier (eltee) from facial surface of upper first molar and lingual surface of the lower central incisor. Each patient will be providing us 20 disc, control(4) and test(16). Disc from control and test group will be evaluated and compared via CFU and CLSM. All the discs will be dipped in broth and incubated for 24 hours. Then we will plate it on agar for CFU. CFU counts will be compared between test and control to evaluate the efficacy of probiotics. Similarly, the absence of biofilms and live/dead bacteria will be analyzed by the CSLM LSM510/ConfoCor2 system.
Disc will be stained with Fluorescent dye (green fluorescence). The absence of a fluorescent signal will prove absence of biofilms on the aligners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •Orthodontic treatment with clear aligners.
- •Complete permanent dentition (excluding third molars) Good general health (no significant medical history or drug use during the last month).
- •No anti inflammatory or antibiotic medications taken in the month before the study.
- •No chewing gum or mouthwash used in the last week and during the study.
- •Habit of brushing twice daily with prescribed fluoride toothpaste.
- •Patient with good periodontal condition.
排除标准
- •Presence of a systemic disease Smoking habit History of periodontal disease Extensive dental restorations History of antibiotics or any antibacterial mouth rinse product use during the last 6 weeks Application of professional dental hygiene procedures in the last 3 months.
结局指标
主要结局
Efficacy of different probiotics on biofilm formed around clear aligners
时间窗: T0- 7 days old aligners(control) | T1- Probiotics gummies for 7 days | T2- Probiotics rinse for 7 days (to be given after 14 days of washout period) | T3- Probiotic Tablets for 7 days(to be given after 14 days of washout period) | T4- Probiotics Yakult for 7 days (to be given after 14 days of washout period)
次要结局
- 1.To evaluate the efficacy of different types of probiotics on biofilm formed around clear aligners using colony forming units(2.To compare the efficacy of different types of probiotics on biofilm formed around clear aligners using colony forming units)