infection of the soft and hard tissues surrounding dental implants peri-implantitis
Conditions
Interventions
Implants with peri-implantitis (both test and control group) will be surgically
treated (apically repositioned flap, bone recontouring, implant surface
debridement and decontamination). The implant
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 (> 3 months); 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is full-mouth peri-implant bleeding score. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Full-mouth periodontal bleeding score; - Full-mouth peri-implant and periodontal suppuration on probing score (%); - Full-mouth peri-implant and periodontal probing pocket depth; - Full-mouth peri-implant and periodontal plaque score (%); - Marginal soft tissue recession (REC); - Radiographic marginal peri-implant bone level on standardized intraoral radiographs; - Microbiological composition of the peri-implant and periodontal area; - 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; - Complications and adverse events. | — |
Countries
Netherlands
Outcome results
None listed