Reducing Microbial Levels in High Caries Risk Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Microbial Levels
研究概览
简要总结
The purpose of the study is to determine the effect of a two-step mouth rinsing procedure on reducing the germs (mutans Streptococci) that cause tooth decay. We hope that the two-step mouth rinse (0.3% NaOCl followed by 10% Povidone Iodine) decreases the tooth causing germs better than the one-step mouth rinse (10% Povidone Iodine). The mouth rinse for both treatment groups is done only once at the beginning of the study after the initial saliva samples are taken, and before a detailed examination of the teeth and gums. It is hypothesized that the treatment group receiving the NaOCl and Povidone iodine will have significantly lower microbial counts than the control group (Povidone iodine) because the NaOCl will disrupt the microbial biofilm and make the Povidone iodine more effective in decreasing the microbes in the biofilm. Microbial counts are made from Salivary samples taken from participants at baseline, one week, one month, two months and three months. The samples are tested by two commercial methods for determining microbial counts. The CariScreen Test is a rapid bioluminescence assay that quantitates the total number of all of the organisms present. The CRT test requires a culture media that is specific for the two germs (S. mutans and Lactobacillus) strongly associated with tooth decay. The results of the CRT Test are read after three days of incubation.
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
This was a single blind study. The participants knew which one time treatment they were receiving, but the person doing the saliva sampling and testing did not know which treatment the participant was assigned
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •being over 20 years of age;
- •having at least one obviously cavitated tooth;
- •refraining from smoking, brushing the teeth and using a mouthwash the day of the bacterial sampling;
- •refraining from using a commercial mouth rinse during the three months of the study;
- •having any two of the following risk factors in the Caries Management by Risk Assessment (CAMBRA) protocol which qualifies as a high caries risk.
- •The high caries risk factors included:
- •receiving fillings within the past three years;
- •snacking frequently between meals;
- •presenting with hyposalivation due to medication, radiation or systemic conditions;
- •visual presence of heavy plaque accumulation;
- •and a minimum of 20 natural teeth.
排除标准
- •using a systemic antibiotic within the past three months;
- •currently receiving dental treatment or planning to receive treatment within the next three months (emergency treatment allowed);
- •being pregnant or nursing;
- •any thyroid disease or sensitivity to iodine;
- •the use of a commercially available mouth rinse the day of the screening examination;
- •smoking, brushing the teeth and using a mouth rinse the day of the bacterial sampling;
- •not being able to make morning examinations.
研究组 & 干预措施
Treatment(TX)
. Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The first treatment group (TX) rinsed with NaOCL (0.3%) for one minute followed by rinsing with iodine (10%) for one minute
干预措施: Iodine (Betadine) (Drug)
Treatment(TX)
. Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The first treatment group (TX) rinsed with NaOCL (0.3%) for one minute followed by rinsing with iodine (10%) for one minute
干预措施: NaOCL (Biological)
Control (CT)
. Participants were assigned randomly to one of two treatment groups and continued in parallel for the three-month duration of the study. The control group (CT) rinsed with iodine (10%) for minute. The CT group was a positive control. Both of these treatments were done only once at the baseline. The reminder of the three-month study was to obtain saliva samples at specific times to determining microbial levels.
干预措施: Iodine (Betadine) (Drug)
结局指标
主要结局
Microbial Levels
时间窗: Baseline, 12 weeks
The CRT® Bacteria (Ivoclar Vivadent) saliva sample test is done on culture media that is specific for S. mutans and Lactobacillus. After incubation for 3 days the colonies are compared to photographic standards.
次要结局
未报告次要终点