Non-surgical Treatment of Peri-implantitis With Electrolytic Cleaning: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Peri-implant disease resolution at 6 month
研究概览
简要总结
Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis.
A prospective clinical and radiographic case series study will be performed to evaluate the clinical performance of the adjunctive use of electrolytic cleaning as an adjunct to a non-surgical therapy protocol that includes curettage of the peri-implant soft tissue. This is study is a proof of principle study, thus, a case series study is selected to start with. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do.
详细描述
Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis. Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis.This is study is a proof of principle study, thus, a case series study is selected to start with. As this is a pilot study to test for the first time the electrolytic cleaning under non-surgical therapy, the sample size has been estimated in a minimum of 25 patients. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do.
Therapeutic success is defined as as a composite index (Sanz & Chapple 2012 criteria of disease resolution) that includes: (1) probing pocket depth < 5 mm, (2) no bleeding on probing/suppuration and (3) no additional bone loss, at 6 and 12 months). Secondary objectives are: Changes in the clinical outcomes measurements.Changes in the radiological outcomes measurements. Changes in the patient-reported outcomes (PROMs). Evaluation of the outcomes related to the prosthetic restoration.
This study will be carried out in the following centers:
- Postgraduate Periodontal Clinic at the Faculty of Odontology-Universidad Complutense of Madrid (Spain)
- CEOSA-Madrid Private Dental Centre
After the non-surgical therapy, patients will be recalled for control visits, with supra- gingival removal of biofilm with air polishing without anaesthesia at:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female age > 18 years.
- •Presence of at least 1 implant with the diagnose of peri-implantitis (Berglundh et al. 2018; Renvert et al. 2018)
- •Peri-implant bone loss < 2/3
- •History of treated periodontal diseases (Caton 2018).
- •Screw retained prosthesis that can be easily unscrewed.
- •Prosthesis that allows access to biofilm control by the patient, or which can be modified accordingly.
- •Absence of implant mobility
排除标准
- •Systemic exclusion criteria
- •Pregnant or lactating women Non-surgical electrolytic cleaning CONFIDENTIAL
- •Patients chronically treated (i.e., two weeks or more) with any medication known to affect periodontal/peri-implant status (i.e., antibiotics intake within 3 months prior to the initiation)
- •Medical conditions requiring prolonged use of steroids and/or with medications that could interfere with bone metabolism.
- •History of leukocyte dysfunction and deficiencies.
- •History of neoplastic disease requiring the use of radiation or chemotherapy.
- •Patients with chronic renal failure requiring dialysis.
- •Patients with metabolic bone disorders such as osteoporosis treated with antiresoptive medications.
- •History of uncontrolled endocrine disorders: hypothyroidism or diabetes.
- •Physical handicaps that would interfere with the ability to perform adequate oral hygiene or patients unable to use daily interproximal cleaning.
- •Alcoholism or drug abuse.
- •History of immunodeficiency syndromes.
- •Tobacco consumption (smoking more than 10 cigarettes per day)
- •Conditions or circumstances, which in the opinion of the investigator, would avoid the completion of study participation, or interfere with analysis of study results, such as history of non-compliance or unreliability, or do have any additional medical condition that contraindicates non-surgical treatment
- •Local exclusion criteria
- •Mucosal diseases such as erosive lichen planus in the area to be treated.
- •History of local irradiation therapy.
- •Implants with peri-implant bone loss beyond 2/3 of the implant length
研究组 & 干预措施
Non-surgical electrolytic cleaning
- Implant hygiene instructions and removal of the prosthesis
- Local anaesthesia
- Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA)
- Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
- Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).
- Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.
- Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
- If necessary, modification and polishing of the prosthesis to make it cleanable.
干预措施: Implant hygiene instructions and removal of the prosthesis (Behavioral)
Non-surgical electrolytic cleaning
- Implant hygiene instructions and removal of the prosthesis
- Local anaesthesia
- Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA)
- Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
- Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).
- Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.
- Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
- If necessary, modification and polishing of the prosthesis to make it cleanable.
干预措施: Non-surgical peri-implantitis treatment /microsurgery (Procedure)
Non-surgical electrolytic cleaning
- Implant hygiene instructions and removal of the prosthesis
- Local anaesthesia
- Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA)
- Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
- Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).
- Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.
- Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
- If necessary, modification and polishing of the prosthesis to make it cleanable.
干预措施: Implant surface decontamination 1(ultrasonic device) (Procedure)
Non-surgical electrolytic cleaning
- Implant hygiene instructions and removal of the prosthesis
- Local anaesthesia
- Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA)
- Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
- Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).
- Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.
- Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
- If necessary, modification and polishing of the prosthesis to make it cleanable.
干预措施: Implant surface decontamination 2 (air polishing) (Procedure)
Non-surgical electrolytic cleaning
- Implant hygiene instructions and removal of the prosthesis
- Local anaesthesia
- Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA)
- Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
- Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).
- Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.
- Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
- If necessary, modification and polishing of the prosthesis to make it cleanable.
干预措施: Implant surface decontamination 3 (electrolytic cleaning) (Procedure)
Non-surgical electrolytic cleaning
- Implant hygiene instructions and removal of the prosthesis
- Local anaesthesia
- Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA)
- Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
- Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).
- Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.
- Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
- If necessary, modification and polishing of the prosthesis to make it cleanable.
干预措施: Antibiotic treatment (Metronidazole) (Drug)
Non-surgical electrolytic cleaning
- Implant hygiene instructions and removal of the prosthesis
- Local anaesthesia
- Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA)
- Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
- Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).
- Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.
- Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
- If necessary, modification and polishing of the prosthesis to make it cleanable.
干预措施: Modification and polishing of the prosthesis (Procedure)
结局指标
主要结局
Peri-implant disease resolution at 6 month
时间窗: 6 months
Probing depth \< 5 mm, with absence of bleeding or suppuration and no additional bone loss (Sanz \& Chapple 2012)
Peri-implant disease resolution at 12 month
时间窗: 12 months
Probing depth \< 5 mm, with absence of bleeding or suppuration and no additional
次要结局
- Implant plaque index at 6 months(6 months)
- Peri-implant probing depth at 12 months(12 months)
- Peri-implant probing depth at 6 months(6 months)
- Suppuration at 12 months(12 months)
- Implant survival rate at 6 months(6 months)
- Implant survival rate at 12 months(12 months)
- Patient centred outcomes of the electrolytic cleaning after 12 months(12 months)
- Implant plaque index at 12 months(12 months)
- Bleeding on probing at 6 months(6 months)
- Bleeding on probing at 12 months(12 months)
- Suppuration at 6 months(6 months)
- Recession of the mucosal margin at 6 months(6 months)
- Patient centred outcomes of the electrolytic cleaning after 6 months(6 months)
- Recession of the mucosal margin at 12 months(12 months)
- Bone loss at 6 months(6 months)
- Bone loss at 12 months(12 months)
- Overall satisfaction after 6 months(6 months)
- Overall satisfaction after 12 months(12 months)