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临床试验/NL-OMON27505
NL-OMON27505招募中不适用

The use of bone substitutes and adjuvant antibiotic therapy in peri-implantitis surgery: a randomised controlled clinical trial

niversity Medical Center Groningen0 个研究点目标入组 123 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
123

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • the patient is =18 years of age;
  • - adult patients with at least one endosseous implant in the oral cavity with clinical and radiographical evidence of peri-implantitis. Peri-implantitis is defined as probing pocket depth (PPD) of = 6mm in combination with bleeding on probing (BOP) or suppuration on probing (SOP) and radiographic bone loss of =3mm after placing the definitive suprastructure (Berglundh et al. 2018);
  • - the implants have been in function for at least 2 years;
  • - the patient is capable of understanding and giving informed consent.

排除标准

  • Exclusion criteria prior to pre-treatment:
  • - medical and general contra-indications for the procedure;
  • - a history of local radiotherapy to the head and neck region;
  • - pregnancy and lactation;
  • - uncontrolled diabetes mellitus (HbA1c <7% or <53 mmol/mol);
  • - use of intravenous bisphosphonates;
  • - known allergy to chlorhexidine, amoxicillin and/or metronidazole;
  • - long-term use of anti-inflammatory drugs
  • - patient is incapable of performing basic oral hygiene measures as a result of physical or mental disorders;
  • - implants with bone loss exceeding 2/3 of implant length or implants with bone loss beyond the transverse openings in hollow implants;
  • - previous surgical treatment of the peri-implantitis lesions;
  • - chronic bronchitis or asthma.
  • Additional exclusion criteria after pre-treatment:
  • - no peri-implantitis remaining: minor BoP (< 20%), PPD < 6mm, plaque < 20%;
  • - active periodontal disease at the remaining dentition (PPD = 6mm, BOP = 20%) or insufficient oral hygiene (plaque = 20%);
  • - use of antibiotics during the last 3 months.

研究者

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