Treatment of Human Gingivitis With Topical ACCS: a Two Week Safety Dose-ranging and Proof-of-principle Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Incidence of adverse/serious adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of oral topical application of Amnion-derived Cellular Cytokine Solution (ACCS) in subjects with gingivitis
详细描述
This randomized blinded study will evaluate the use of ACCS in subjects with gingivitis. Two doses of ACCS will be used. It will be given topically intra-orally daily Monday through Friday for 2 weeks. In the first cohort, a low dose of ACCS or saline will be given by random chance. If there are no safety issues, cohort two will include a higher dose of ACCS randomized with saline. Pocket depth, plaque index, gingival index, and bleeding on probing will be assessed. To assess shifts in supragingival flora, a qualitative and quantitative microbial analysis will be performed for common oral bacteria. There will also be an analysis of inflammatory cytokines in crevicular fluid at the beginning and end of the study. Comparisons of adverse events and outcomes will be made between the subjects receiving low dose ACCS, high dose ACCS, and saline.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •good general health
- •ages 18-70 years
- •minimum of 20 natural teeth
- •modified gingival index score of 2.0 or greater and >40 percent bleeding sites at initial presentation.
排除标准
- •presence of orthodontic appliance
- •soft or hard tissue tumor of the oral cavity
- •carious lesion requiring immediate treatment
- •participation in another clinical trial within 30 days
- •pregnant or breast-feeding women
- •women of child-bearing potential refusing to use an acceptable method of birth control
- •antibiotic therapy within the last 30 days
- •chronic use (> 3 times/week) of non-steroidal anti-inflammatory medications (NSAID). Any use of steroids. Low dose (<325 mg) aspirin is allowed.
- •immune-compromised subjects
- •subjects with liver or kidney dysfunction on blood tests as evidenced by a value equal to or greater than 2X the upper limit of normal.
- •any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues such as diabetes rheumatoid arthritis, Crohn's disease, use of nifedipine, phenytoin (Dilantin), anticoagulant medications (e.g. warfarin), ongoing cancer treatment either with radiation of chemotherapy.
研究组 & 干预措施
Low dose 0.3X ACCS
20 microliters of 0.3X ACCS per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks
干预措施: 0.3X ACCS (Drug)
High dose 1X ACCS
20 microliters of 1X ACCS per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks
干预措施: 1X ACCS (Amnion-derived Cellular Cytokine Solution) (Drug)
Normal saline
20 microliters of saline placebo per tooth is applied directly excluding third molars by dental professional daily Monday through Friday for two weeks
干预措施: Normal saline (Drug)
结局指标
主要结局
Incidence of adverse/serious adverse events
时间窗: End of two weeks of treatment and at two weeks follow-up visit
次要结局
- Probing pocket depth(Bseline and after two weeks of treatment)
- Modified gingival index(Baseline and after two weeks of treatment)
- Bleeding on probing(Baseline and after two weeks of treatment)
- Plaque index(Baseline and after two weeks of treatment)
- Microbial analysis(Baseline and after two weeks of treatment)
- Cytokine analysis(Baseline and after two weeks of therapy)