Clinical and microbiological evaluation of different implant surface decontaminating procedures in the surgical treatment of peri-implantitis; a randomized controlled study
- Conditions
- infection of the gingiva surrounding a dental implantperi-implantitis10004018
- Registration Number
- NL-OMON39778
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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.
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is the modified bleeding index.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary study parameters are:<br /><br>- Microbial composition of the biofilm covering the dental implant surface;<br /><br>- Microbiological composition of the peri-implant sulcus;<br /><br>- Probing pocket depth;<br /><br>- Suppuration on probing;<br /><br>- Radiographic marginal bone level on standardized intraoral radiographs;<br /><br>- Modified plaque index;<br /><br>- Implant calculus index;<br /><br>- Marginal soft tissue recession (REC);<br /><br>- Implant failure, defined as implant mobility of previously clinically<br /><br>osseointegrated implants and removal of non-mobile implants because of<br /><br>progressive marginal bone loss or infection;<br /><br>- Complications and adverse events;</p><br>