Metronidazole as an Adjunct of Non- Surgical Treatment of Peri-implantitis : a 6-months Placebo- Controlled Clinical Trial in Humans
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in probing depth
研究概览
简要总结
The use of systemic antibiotics as and adjunct to non-surgical peri-implant therapy may be an improvement in comparison to these therapies alone. The primary objective is the evaluation of significant changes in probing pocket depth between non-surgical with or without antibiotics.
This is a controlled-placebo clinical trial design. Patients with osseointegrated oral implants will be selected and recruited from a university clinic. Oral hygiene instruction and non-surgical debridement at implants will be provided with ultrasonic devices and immediately after, patients will be prescribed:
Group Control: A placebo with the same characteristics as the antibiotic Group Test: Systemic antibiotics (Metronidazole 250mg, 2 capsules three times a day, for 7 days Three and six months after non-surgical treatment, clinical parameters will be registered and radiographs compared using reproducible landmarks. Any adverse event will be also recorded.
详细描述
Microbial colonization of implant surface is the main causative factor of periimplantitis. Non-surgical treatment have been shown to be ineffective in bacterial control. The capacity of certain bacteria to invade soft tissues in periodontal lesions and a possible invasion in peri-implant diseases, could also be a good reason. Mombelli and Lang in a case-series study observed a significant reduction on probing depths and microbial parameters after non-surgical treatment and systemic antimicrobial therapy (ornidazole) of implants affected by marked loss of bone.
The rationale for conducting this research is to demonstrate that there may be significant differences in clinical, radiographic and microbiological parameters if systemic metronidazole is prescribed in conjunction with non-surgical treatment of peri-implantitis lesions. If there are differences, and a further improvement is observed in evaluated parameters, treatment protocols for these prevalent lesions could have been modified.
The objective of this research is to check whether there are differences in clinical, radiographic and microbiological parameters when performing non-surgical treatment to treat peri-implantitis with adjunctive administration of systemic metronidazole or a placebo.
Design: This research is designed as a parallel group, placebo-controlled, randomized, double-blind clinical study.
Population: Patients who come to the Periodontology Department, Faculty of Dentistry, University of Santiago de Compostela with dental implants presenting pathology.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
It will not be possible to know which patient will correspond the prescription of the antibiotic or the placebo until the end of treatment. One of the researchers will be masked and will deliver the boxes with the placebo or the antibiotic according to the result of randomization. He will be different from the researcher who perform the treatment. This means that the treatment group will be masked to patients and dentists.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older than 18 years.
- •Presence of at least 1 implant diagnosed with peri-implantitis (Presence of BOP and/or suppuration, with 2 mm of detectable bone loss after initial remodeling, and PD≥ 4 mm as defined by Daubert et al. 2015).
- •Absence of implant mobility.
- •History of taking systemic antibiotics in the preceding 3 months.
- •No systemic pathology that contraindicated the completion of treatment.
- •The patient understands the treatment and willing to comply.
- •The patient is willing to give written informed consent and can do
排除标准
- •Pregnant.
- •Metronidazole allergies
- •Patients on treatment with bisphosphonates.
- •Uncontrolled periodontal disease.
研究组 & 干预措施
Metronidazole 250mg
Systemic antibiotic: Metronidazole 250mg , 2 capsules three times a day, for 7 days.
干预措施: Metronidazole 250 MG (Drug)
Placebo
Placebo: same shape, size and dosis as test
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Change in probing depth
时间窗: baseline, 2 and 6 months after treatment
Probing depth is the distance from the gingival margin to the bottom of the periodontal pocket (junctional epithelium). It is measured with a millimetric probe CP15 Hu-Friedy UNC at six points in each implant (mesial, distal and medial in buccal and lingual).
次要结局
- Attachment level(baseline, 2 and 6 months after treatment)
- Recession(baseline, 2 and 6 months after treatment)
- Bleeding Index(baseline, 2 and 6 months after treatment)
- Peri-implant bone loss.(baseline, 2 and 6 months after treatment)
- plaque index(baseline, 2 and 6 months after treatment)
- Microbiological variable(baseline and 6 months after treatment)
研究者
Juan Blanco Carrión
Principal investigator
University of Santiago de Compostela