Effect of a Maintenance Protocol Based on the Surgical Treatment of Peri-implantitis and Implant Surface Decontamination With Glycine Powder Air-polishing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Probing Pocket Depth
研究概览
简要总结
This study was designed as a 12-month, two arms, randomized clinical trial to evaluate the efficacy of a supportive treatment protocol (SPIT). Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups. After ultrasonic debridement, the affected implant surfaces of the test group were treated with glycine powder air-polishing, while implants in the control group a rubber cup and polishing paste was used. Maintenance visits were carried every 3 months and clinical, radiological, microbiological and biochemical variables were registered at baseline (6 months after surgery) and after a follow-up period of 12 months (18 months after surgery).
详细描述
Study design:
This study was designed as a 12-month, two arms, RCT to evaluate the efficacy of a SPIC protocol. Thirty patients were randomized, six months after access-flap surgery, in two different SPIT groups. After ultrasonic debridement, the affected implant surfaces of the test group were treated with glycine powder air-polishing, while implants in the control group a rubber cup and polishing paste was used. Maintenance visits were carried every 3 months and clinical, radiological, microbiological and biochemical variables were registered at baseline (6 months after surgery) and after a follow-up period of 12 months (18 months after surgery).
Interventions:
At the 6-month evaluation after the surgery, the baseline data for the present study were obtained and patients were randomised using a computerized block randomization protocol to one of the following SPIC protocols. In the test group, implant surfaces were treated with glycine powder air-polishing after ultrasonic instrumentation; the specific nozzle was activated subgingivally and circumferentially around the implant for 1 minute. In the control group, implants were cleaned with a rubber cup and polishing paste after ultrasonic instrumentation. This SPIC visits were carried out at 6 (baseline visit), 9, 12, 15 and 18 months after surgery.
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 (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of at least one implant with peri-implantitis, defined as: radiographic evidence of bone loss >2 mm, inflammation of the peri-implant mucosa as defined by positive BoP and/or suppuration, and at least one site with PD ≥ 5 mm.
- •Based on the radiographic examination, the affected implant should not have a vertical peri-implant defect. Positive selection was based on the presence of pe-ri-implant lesions wider than 4 mm, with an angle greater than 35 º.
- •In patients with a history of periodontitis, periodontal therapy should have been provided at least 6 months prior to the initiation of the study.
排除标准
- •Presence of relevant medical conditions and/or systemic medications that would contraindicate the surgical procedure or modify the tissue response after therapy.
- •Patients requiring antibiotic prophylaxis.
- •Heavy smokers (> 10 cigarettes/day).
- •Pregnant or lactating women
结局指标
主要结局
Probing Pocket Depth
时间窗: Baseline, 6 and 18 months after the surgical procedure
Changes in Probing Pocket Depth measured in milimeters with a manual periodontal probe
次要结局
- Plaque Index(Baseline, 6 and 18 months after the surgical procedure)
- Radiographic bone loss distance measured from the prosthetic connection platform to the bottom of the intraosseous defect(Baseline, 6 and 18 months after the surgical procedure)
- Distance of Gingival Recession(Baseline, 6 and 18 months after the surgical procedure)
- Suppuration Index(Baseline, 6 and 18 months after the surgical procedure)
- Proportions of putative periodontal pathogens(Baseline, 6 and 18 months after the surgical procedure)
- Bleeding on Probing index(Baseline, 6 and 18 months after the surgical procedure)
- Concentration of the selected cytokines measured in pg/ml (IL1B; Il-6; IL-8; Tumoral Necrosis Factor Alpha)(Baseline, 6 and 18 months after the surgical procedure)
- Frequency of detection of putative periodontal pathogens(Baseline, 6 and 18 months after the surgical procedure)
- Presence of putative periodontal pathogens(Baseline, 6 and 18 months after the surgical procedure)
- Counts of putative periodontal pathogens(Baseline, 6 and 18 months after the surgical procedure)