EUCTR2012-000836-24-GB进行中（未招募）1 期
Multi-Center Phase 3 Trial of Minocycline HCl 1mg Microspheres for the Use in Subjects with Peri-Implantitis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 215
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
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.
- •- Male subjects who are not surgically sterilized must be practicing an effective method of birth control for the duration of the study.
- •- Female subjects of childbearing potential must be practicing an effective method of birth control.
- •- Must be free from any significant oral soft tissue pathology.
- •- Must have a minimum of one (1) osseointegrated (e.g., endosteal root form/cylindrical) implant with a diagnosis of peri-implantitis
- •- Must have at least one peri-implant site with an average of 2 PD readings =5 to =7 mm when using a light force and with BOP within 30 seconds of the probing and evidence of pathologic bone loss. Peri-implant bone loss will be confirmed by a dentist (Investigator, treating clinician or examiner) through the use of a recent (6 months or less) radiograph (a panoramic film is acceptable). If a recent radiograph is not available, a radiograph (i.e. periapical) will be taken at the Screening visit.
- •- At least 1mm of keratinized gingiva around the implant must be present.
- •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 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •- Females having a positive urine pregnancy result at the time of randomization
- •- Male subjects reporting pregnancy or lactation of their partner.
- •- 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 history of tuberculosis
- •- Subjects diagnosed with clinically significant or unstable organic disease(e.g., severely impaired liver function or acute or chronic end stage renal failure), or compromised healing potential
- •- Subjects taking antibiotics or other medication as described in Section 8.7 of the protocol
- •- Subjects who have taken any 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 due to anticipated poor compliance with study visits (e.g., transportation challenges or personal issues)
- •- Subjects presenting with signs of untreated advanced periodontal disease and/or poor oral hygiene
- •- Subjects having an average of 2 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 Investigator
研究者
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