Effect of COMORAL® the Oral Irrigation Unit in Preventing Gingivitis and Plaque Formation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- gingival index (GI)
研究概览
简要总结
This is a clinical study to evaluate the safety and effectiveness of COMORAL®, the intraoral water-spraying cleaning device that is developed to remove plaque around teeth in the oral cavity. To do so, 42 healthy subjects, 21 control and 21 experimental, will be recruited.
To establish the baseline, all subjects will receive dental hygiene service. After 2 weeks, patients will be randomly assigned to either control or intervention group (21 individuals each). Both groups will be asked to brush their teeth once a day but without dental floss, mouth rinse, and gum chewing, throughout the 4 weeks of study period. During the study period, the experimental group will receive COMORAL® treatment three times a day every day for 4 weeks except Saturday and Sunday.
Subjects will get evaluated for the oral status(PI, BOP, GI, PD, GR, CAL) and the status of periopathogens on visit 1, visit 2 and visit 3.
详细描述
This is a randomized, open-labeled, single-centered clinical study to evaluate COMORAL® the intraoral water-spraying cleaning device that is developed to remove plaque around teeth in the oral cavity. The purpose of this clinical study is to evaluate the safety and effectiveness of COMORAL® the oral irrigation unit in preventing gingivitis and plaque formation in adult patients.
42 patients between 18 to 25 years old who have a periodontal probing depth of 3 mm or less will be recruited. To establish the baseline, all the patients will receive dental hygiene service.
After 2 weeks (Visit 1), patients will be randomly assigned to either control or intervention group (21 individuals each). They will be asked to do the following instruction; Control group (21 total) - The individuals in the control group will be asked to brush their teeth once a day at home throughout the 4 weeks of study period. They will be asked not to use the supplementary oral hygiene products including mouth rinse, dental floss and chewing gum.
Experimental/Intervention group (21 total) - The individuals in this group will be asked to brush their teeth once a day at home throughout the 4 weeks of study period. They will be asked not to use the supplementary oral hygiene products including mouth rinse, dental floss and chewing gum. Instead, they will be asked to come to the clinic to use COMORAL® three times a day, every day except Saturday and Sunday.
Subjects in both groups will be evaluated for clinical indices (PI, BOP, GI, PD, GR, CAL) and the status of periopathogens on visit 1(baseline, visit 2(after 2 weeks), and visit 3(after 4 weeks). To measure the status of periopathogens, 3ml of saliva will be collected from each subject.
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
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult patients (ASA 1-2) aged 18 to 25 with a probing depth of 3mm or less
- •Those with 3 or more natural teeth in each quartile
- •Those who can voluntarily sign the consent form
排除标准
- •Existing dental caries
- •Existing periodontitis
- •Other oral diseases
结局指标
主要结局
gingival index (GI)
时间窗: Baseline, 2 weeks, 4 weeks
the scoring system for mild inflammation(modified gingival index)
gingival recession (GR)
时间窗: Baseline, 2 weeks, 4 weeks
the distance of the displacement of marginal gingiva apical to the cemento-enamel junction
clinical attachment loss (CAL)
时间窗: Baseline, 2 weeks, 4 weeks
the distance between the cementoenamel junction and the base of the probeable pocket
bleeding on probing (BOP)
时间窗: Baseline, 2 weeks, 4 weeks
the scoring system recorded 20 seconds after probing the depth of the pocket
pocket depth (PD)
时间窗: Baseline, 2 weeks, 4 weeks
the distance from the gingival margin to pocket base
plaque index (PI)
时间窗: Baseline, 2 weeks, 4 weeks
the amount of dental plaque visible on the vestibular and lingual surfaces
次要结局
- Periopathogens (PP)(Baseline, 2 weeks, 4 weeks)
研究者
Reuben Kim, DDS, PhD
Professor and Chair
University of California, Los Angeles