Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics A Prospective, Double Blind, Randomized, Three Armed, Parallel, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Probing pocket depth change and bone level stability
研究概览
简要总结
The purpose of this study is to investigate if the use of systemic adjunctive antibiotics in the treatment of periimplantitis is needed.
详细描述
This study will give the opportunity to draw scientifically based conclusions on the recommendations of the use of adjunctive systemic antibiotics in the treatment of peri-implantitis. This study will also be able to determine the ecological impact on the oropharyngeal and intestinal microflora between different antibiotic treatments. The lack of knowledge in this area has been highlighted by the Food and Drug Administration and The Swedish Council on Health Technology Assessment (SBU)
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18-65 year
- •Patients who has been referred by a general dentist to a specialist clinic in periodontology for treatment of peri-implantitis.
- •Having sign of peri-implantitis around at least one osseointegrated dental implant that has been in function for ≥ one year
- •Peri-implantitis is diagnosed when; PPD of ≥ 6mm can be found at a dental implant in association with BOP and/or suppuration together with the loss of marginal alveolar bone of more than 2 mm detected on intraoral radiographs (giving radiographic exposure of at least ≥ 3 fixture threads).
- •Partially or completely edentulous subjects with healthy or treated periodontal conditions enrolled in a regular supportive program.
- •Full-Mouth Plaque Score (FMPS) ≤ 25
- •Signed informed consent
排除标准
- •Known allergy to amoxicillin, penicillin (PcV), metronidazole or betalactamic
- •Contraindication for dental surgical treatment (i.e. immunocompromised, uncontrolled DM (B-GHb-A1C 8-9 %, 64-75 mmol/mol), osteoporosis, I.V bisphosphonate treatment due to malignancy, pregnant and lactating women).
- •Incapability to perform basal oral hygiene measures due to physical or mental disorders.
- •Received systemic antimicrobial therapy in the past three months.
- •Currently on allopurinol, digoxin, disulfiram, lithium, busulfan, 5-fluorouracil, methotrexate, phenytoin, cyclosporine and warfarin.
- •Known severe chronic peripheral or central disease of the nervous system
- •Known alcohol abuse
- •Known hepatic encephalopathy
- •Known lactose intolerance, galactose intolerance
- •Untreated periodontal condition.
- •Implant showing sign of mobility.
- •Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond any transverse openings in hollow implants.
- •Any medical condition or on any concomitant medication that, in the opinion of the investigator, might interfere with the evaluation of the study objectives or jeopardize patient safety
- •Patients with xerostomia or having slow bowel motion will be excluded from the group of patients providing salivary and fecal samples.
研究组 & 干预措施
Placebo
Patients with periimplantitis undergoing surgical treatment with will receive placebo three times daily (TID)
干预措施: Placebo (Drug)
amoxicillin + metronidazole
Patients with periimplantitis undergoing surgical treatment with amoxicillin (500 mg TID) + metronidazole (400 mg TID) for 7 days
干预措施: Amoxicillin Sandoz (Drug)
amoxicillin + metronidazole
Patients with periimplantitis undergoing surgical treatment with amoxicillin (500 mg TID) + metronidazole (400 mg TID) for 7 days
干预措施: Metronidazole Sanofi (Drug)
phenoxymetylpencillin + metronidazol
Patients with periimplantitis undergoing surgical treatment with phenoxymetylpencillin, (800mg×2 TID) + metronidazol (400 mg TID) for 7 days
干预措施: Metronidazole Sanofi (Drug)
phenoxymetylpencillin + metronidazol
Patients with periimplantitis undergoing surgical treatment with phenoxymetylpencillin, (800mg×2 TID) + metronidazol (400 mg TID) for 7 days
干预措施: Phenoxymethylpenicillin Meda (Drug)
结局指标
主要结局
Probing pocket depth change and bone level stability
时间窗: 0,6 and 12 months
次要结局
- Change of clinical soft tissue inflammation, bleeding on probing (BOP)(0, post operative 12 month)
- Soft tissue recession (REC) and clinical attachment level gain (CAL)(0,6 and 12 month)
- • Quantitative and qualitative change in levels of the peri-implant periopathogenic microflora(0,6 and 12 months)
- • Susceptibility changes of the oral and intestinal microflora to amoxicillin, metronidazole and penicillin.(0,6 and 12 month)
- Quantitative and qualitative changes in the oral and intestinal microflora(0,6 and 12 month)
- Concentration of amoxicillin, metronidazole and PcV in saliva and feces(0, 6 and 12 month)
- • Follow-up of adverse events related or unrelated to the investigated medical products(0,6, and 12 month)
研究者
Margareta Hultin
DDS
Karolinska Institutet