EUCTR2007-005660-27-IT进行中（未招募）不适用
Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects with Peri-Implantitis - NIRVANA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •At least 21 years of age and in good general health subjects (and/or their legally acceptable representatives) must have read and signed an Informed Consent Form indicating that they fully understand the purpose and procedures required for the study and are willing to participate in the study. Each subject will receive a copy of his/her signed Informed Consent document. Willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study. At time of enrollment, females must have a negative urine pregnancy results. Must be partially edentulous and free from any significant oral soft tissue pathology (Note: subjects who present with one fully edentulous arch are still eligible for participating in the study). Must have a minimum of one* (1) osseointegrated, implant with a diagnosis of peri-implantitis defined as at least one peri-implant site with PD ≥5 mm when using a light force (0.2N) with BOP within 30 seconds of the probing and evidence of pathologic bone loss. Furthermore, there must be a presence of at least 1mm of keratinized gingiva around the implant.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Females self-reporting pregnancy or lactation, or having a positive urine pregnancy results at the time of enrollment (***see below). Subjects reporting allergy to a tetracycline-class drug Subjects with any systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures Subjects with any active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis Subjects diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement Subjects who have taken an investigational drug within 30 days of enrollment Subjects who have participated in a dental clinical trial 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 Any subject that at the discretion of the investigator should not be included in the study *** If a female subject in the Test Group reports pregnancy at either interim visit, no study drug will be re-administered and the subject will be included in the intent-to-treat (ITT) analysis, but will be excluded from per-protocol (PP) analysis. Subjects presenting with signs of advanced periodontal disease and/or poor oral hygiene Subjects having a PD >7mm at any peri-implant site(s) at time of enrollment Subjects presenting with mobility of any dental implant Subjects having a qualifying implant under occlusal trauma or overloaded, as determined by the examiner.
研究者
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