infection of the gingiva surrounding a dental implant peri-implantitis
Conditions
Interventions
Sponsors
Eligibility
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 a fixed reference point on the dental implant, in combination with bleeding and/or suppuration on probing and a peri-implant probing depth >= 5 mm; 3) The implants have been exposed to the oral environment 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) Diabetes; 5) Systemic use of antibiotics during the last 3 months; 6) Long-term use of anti-inflammatory drugs; 7) Incapability of performing basal oral hygiene measures as a result of physical or mental disorders; 8) Active, uncontrolled periodontal pathology of the remaining dentition; 9) Local use of antibiotics or use of other anti-septic / antimicrobial therapies in the oral cavity during the last 3 months; 10) Use of mouthrinses; 11) Bruxism; 12) Implants placed in skin grafted areas; 13) Implants with bone loss due to other reasons than bacterial infection (e.g. loose screw, inadequate positioning of the implant); 14) Implants with bone loss exceding 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 postition 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 parameters is microbial composition of the biofilm covering the dental implant surface. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary study parameters are: - Modified bleeding index - Probing pocket depth - Suppuration on probing - Microbiological composition of the peri-implant sulcus - Radiographic marginal bone level on standardized intraoral radiographs - Modified plaque index - Implant calculus index - Marginal soft tissue recession (REC) - 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 - Patient satisfaction | — |
Countries
Netherlands