Single Blind, Randomized, Active-controlled Comparative Clinical Trial to Evaluate Clinical Efficacy and Safety Following the Application for 4 Weeks of Bio Mineral Toothpaste in Patients With Mild Periodontitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.
研究概览
简要总结
The hypothesis of this study is that using "Bio Mineral" toothpaste for 4 weeks will decrease plaque and gingivitis of mild periodontitis patients compared to patients using "Perio Total Care" toothpaste.
This study is Single blind, Randomized, Active-controlled Comparative clinical trial to evaluate clinical efficacy and safety following the application for 4 weeks of Bio Mineral toothpaste in patients with mild periodontitis.
详细描述
This study is Single blind, Randomized, Active-controlled Comparative clinical trial to evaluate clinical efficacy and safety following the application for 4 weeks of Bio Mineral toothpaste in patients with mild periodontitis. 30 patients of treatment group and 30 patients of control group, total 60 patients will be enrolled to this study. Every patients will use investigational toothpaste 2 times everyday for 4 weeks and brush their teeth at least 3 minutes each time with 1ml of toothpaste.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A healthy man or menopausal woman who is at least 18 to maximum 63 years of age.
- •Agreed to participate voluntarily in the study.
- •Must have over 20 maxillary teeth
- •Must have mild periodontal disease which can induce mild plaque.
- •Having no general disease except for dental disease.
- •Must be able to understand and carry out the trial's objective and method.
排除标准
- •Who has history of using antimicrobials or antibiotics during the past 30 days.
- •Who has history of periodontal treatment during the past 30 days.
- •Who has acute pain or severe suppuration caused by pericoronitis of the wisdom tooth.
- •Who has hypersensitive conditions caused by Gingivitis or periodontitis.
- •Who having restorative dentistry or wearing braces widely.
- •Who using tobacco products (Except for who quit smoking)
- •Who has been participated in other clinical trials during the past 4 weeks.
- •Who judged inappropriate to participate in the study by investigator
结局指标
主要结局
Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.
时间窗: 0 to 4 weeks
Changes in score of "Turesky Modification of the Quigley-Hein Plaque Index" at 4 weeks from baseline.
Changes in score of "Modified Gingival Index" at 4 weeks from baseline.
时间窗: 0 to 4 weeks
Changes in score of "Modified Gingival Index" at 4 weeks from baseline.
次要结局
- Changes in score of "BOP(Bleeding on probing)" at 4 weeks from baseline.(0 to 4 weeks)
- Compare Satisfaction of treatment group to Control Group at 4 weeks using Satisfaction Questionnaire.(4 weeks)
研究者
Youngkyung Ko
Assistant professor
Seoul St. Mary's Hospital