infection of the soft and hard tissues surrounding dental implants peri-implantitis
Conditions
Interventions
Patients with implants affected by peri-implantitis will receive initial
periodontal treatment existing of oral hygiene instructions and mechanical
cleansing of both implants and remaining dentition
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; 10) Full edentulism (no remaining teeth, only implants) 11) Incapability of performing basal oral hygiene measures as a result of physical or mental disorders; 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; 18) Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curretage).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the mean peri-implant bleeding score. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Full-mouth periodontal bleeding score; - Mean peri-implant and full-mouth periodontal suppuration on probing score (%); - Mean peri-implant and full-mouth periodontal probing pocket depth; - Mean peri-implant and full-mouth 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; - Need for additional surgery at teeth and implants - 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; - Tooth loss, defined as removal of teeth because of progressive marginal bone loss or infection; - Complications and adverse events. | — |
Countries
Netherlands
Outcome results
None listed