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 periimplantitis. 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) Insuline-dependent 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 natural dentition (PPD > 5mm); 9) Implants placed in skin grafted areas; 10) Implants with bone loss due to other reasons than bacterial infection (e.g. loose screw, inadequate positioning of the implant); 11) 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; 12) Implant mobility; 13) Implants at which no position can be identified where proper probing measurements can be performed; 14) Previous surgical treatment of the peri-implantitis lesions;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the modified bleeding index. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary study parameters are: - Microbial composition of the biofilm covering the dental implant surface; - Microbiological composition of the peri-implant sulcus; - Probing pocket depth; - Suppuration on probing; - 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; | — |
Countries
Netherlands