Systemic Antibiotic Therapy (Amoxicillin Plus Metronidazole) as an Adjunct to Initial Non-surgical Treatment of Peri-implantitis; a Single Blind Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- change from baseline mean peri-implant bleeding score at 3 months
研究概览
简要总结
The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plus metronidazole therapy in conjunction with initial non-surgical treatment of peri-implantitis. The secondary objective is to assess the microbiological effectiveness of this peri-implantitis treatment approach.
The present study is a single-blind, randomized controlled clinical trial. Adult patients with at least one endosseous implant in the oral cavity with clinical and radiographical evidence of periimplantitis will be included in this study.
Patients with implants affected by peri-implantitis will receive initial periodontal treatment existing of oral hygiene instructions and mechanical cleansing of both implants and remaining dentition. Immediately after initial periodontal therapy patients will be instructed to rinse their mouth with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds for 2 weeks. Additionally patients will receive a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days or no recipe.
The main study parameter is the mean peri-implant bleeding score.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is ≥ 18 years of age;
- •The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as a loss of marginal bone ≥ 2 mm as compared to the shoulder of the implant (the level at which the bone is normally located immediately after implant placement), in combination with bleeding and/or suppuration on probing and a peri-implant probing depth ≥ 5 mm;
- •The implants have been in function for at least two years;
- •The patient is capable of understanding and giving informed consent.
排除标准
- •Medical and general contraindications for the surgical procedures;
- •A history of local radiotherapy to the head and neck region;
- •Pregnancy and lactation;
- •Uncontrolled diabetes (HbA1c < 7% or < 53 mmol/mol)
- •Mononucleosis infectiosa
- •Organic neurological disorders
- •Use of antibiotics during the last 3 months;
- •Known allergy to amoxicillin, metronidazole or chlorhexidine;
- •Long-term use of anti-inflammatory drugs;
- •Full edentulism (no remaining teeth, only implants)
- •Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
- •Implants placed in areas augmented with autogenous bone from the crista iliac region;
- •Implants placed in skin grafted areas;
- •Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants;
- •Implant mobility;
- •Implants at which no position can be identified where proper probing measurements can be performed;
- •Previous surgical treatment of the peri-implantitis lesions;
- •Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curettage)
研究组 & 干预措施
Antibiotics group
Patients will receive full-mouth mechanical cleansing of both implants and remaining dentition using ultrasonic instruments (EMS®) and hand instruments (scalers and curettes) in one or multiple sessions (max. 4). Prior to each session patients will rinse their mouth using 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol during 30 seconds. At the final session all previously cleaned areas will be re-examined and cleaned. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days plus a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks.
干预措施: amoxicillin 500 mg + metronidazole 500 mg (Drug)
Antibiotics group
Patients will receive full-mouth mechanical cleansing of both implants and remaining dentition using ultrasonic instruments (EMS®) and hand instruments (scalers and curettes) in one or multiple sessions (max. 4). Prior to each session patients will rinse their mouth using 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol during 30 seconds. At the final session all previously cleaned areas will be re-examined and cleaned. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days plus a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks.
干预措施: non-surgical periodontal and peri-implant treatment (Procedure)
Control group
Patients will receive full-mouth mechanical cleansing of both implants and remaining dentition using ultrasonic instruments (EMS®) and hand instruments (scalers and curettes) in one or multiple sessions (max. 4). Prior to each session patients will rinse their mouth using 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol during 30 seconds. At the final session all previously cleaned areas will be re-examined and cleaned. At the end of the final treatment session, the dental hygienist will give the patients an envelop containing a recipe for 500 ml mouthrinse (0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol, Perio-Aid®). After the final session patients will rinse their mouth using that mouthrinse twice daily during 30 seconds for 2 weeks.
干预措施: non-surgical periodontal and peri-implant treatment (Procedure)
结局指标
主要结局
change from baseline mean peri-implant bleeding score at 3 months
时间窗: 3 months after therapy
in percentages ranging from 0 (no change) to 100 (improvement)
次要结局
- change from baseline full-mouth periodontal bleeding score at 3 months(3 months after therapy)
- change from baseline mean peri-implant and baseline full-mouth periodontal suppuration on probing score at 3 months(3 months after therapy)
- change from baseline mean peri-implant and full-mouth periodontal probing pocket depth at 3 months(3 months after therapy)
- change from baseline mean peri-implant and full-mouth periodontal plaque score at 3 months(3 months after therapy)
- change from baseline marginal soft tissue level at 3 months(3 months after therapy)
- change from baseline radiographic marginal peri-implant bone level at 3 months(3 months after therapy)
- change from baseline in detection frequency of 7 periodontal pathogens potentially residing in the peri-implant and periodontal area at 3 months(3 months after therapy)
- number of patients in need for additional surgery at teeth and implants(3 months after therapy)
- number of patients with implant failure, defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection(3 months after therapy)
- number of patients with tooth loss, defined as removal of teeth because of progressive marginal bone loss or infection(3 months after therapy)
- number of patients with adverse events related to the treatment(3 months after therapy)