Systemic antibiotic therapy (amoxicillin plus metronidazole) as an adjunct to surgical treatment of peri-implantitis; a single blind randomized controlled study - Systemic amoxicillin plus metronidazole in surgical peri-implantitis treatment

niversity Medical Center Groningen0 个研究点开始时间: 2013年10月18日最近更新: 2014年3月31日

适应症

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•1) The patient is = 18 years of age;
•2) 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;
•3) The implants have been in function for at least two years;
•4) The patient is capable of understanding and giving informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1) Medical and general contraindications for the surgical procedures;
•2) A history of local radiotherapy to the head and neck region;
•3) Pregnancy and lactation;
•4) Uncontrolled diabetes (HbA1c < 7% or < 53 mmol/mol)
•5) Mononucleosis infectiosa
•6) Organic neurological disorders
•7) Use of antibiotics during the last 3 months;
•8) Known allergy to amoxicillin, metronidazole or chlorhexidine;
•9) Long-term use of anti-inflammatory drugs;
•10) Full edentulism (no remaining teeth, only implants)
•11) Active periodontal disease at remaining dentition (PPD=6mm, bleeding=20%) and/or insufficient oral hygiene (plaque=20%)
•12) Implants placed in areas augmented with autogenous bone from the crista iliac region;
•13) Implants placed in skin grafted areas;
•14) 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;
•15) Implant mobility;
•16) Implants at which no position can be identified where proper probing measurements can be performed;
•17) Previous surgical treatment of the peri-implantitis lesions;

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