NCT00662532已完成3 期
Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects With Peri-Implantitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- OraPharma
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Overall PD Reduction
研究概览
简要总结
This study is for people at least 21 years old who have signs of problems, like swollen gums and shrinking bones, by dental implants.
详细描述
At Visit 1, the dentist will:
- do an oral exam
- ask some questions
- decide if the person qualifies for being in the study
- make an appointment for Visit 2 if they qualify
At Visit 2 (Baseline), the dentist will:
- do a special cleaning of the implants
- examine the whole mouth
- collect some fluid
- take x-rays
- put the people into one of two groups (taking into account whether or not they smoke)
- one group will have the study antibiotic put on all the areas in their mouth with gum problems
- the other group will not receive the antibiotic At Visit 3 (about a month later), only fluid samples will be collected.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 years of age and good general health
- •appropriately documented Informed Consent
- •willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol
- •female subjects must meet the pregnancy and contraceptive requirements
- •must have oral health appropriate for study inclusion
排除标准
- •oral health inappropriate for study inclusion
- •females self-reporting pregnancy or lactation, or having a positive urine pregnancy result
- •reporting any of the following conditions:
- •allergy to a tetracycline-class drug
- •systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures
- •active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
- •diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement
- •participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment
- •employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator
- •anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results
研究组 & 干预措施
Minocycline HCl
Experimental
1 mg microspheres of minocycline hydrochloride
干预措施: Minocycline HCl (Drug)
结局指标
主要结局
Overall PD Reduction
时间窗: Baseline to Day 180
Mean reduction of probing depth (PD) of qualified implant sites is derived by calculating the change of PD per qualified implant site (PD at baseline minus PD at post-baseline), and then averaging the site-specific PD changes per subject
次要结局
- Initial PD Reduction(Baseline to Day 90)
- BOP Percent Reduction From Baseline(at Day 90 and Day 180)
研究者
研究点 (1)
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