Systemic antibiotic therapy (amoxicillin plus metronidazole) as an adjunct to surgical treatment of peri-implantitis; a single blind randomized controlled study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

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

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;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is full-mouth peri-implant bleeding score.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Full-mouth periodontal bleeding score;<br /><br>- Full-mouth peri-implant and periodontal suppuration on probing score (%);<br /><br>- Full-mouth peri-implant and periodontal probing pocket depth;<br /><br>- Full-mouth peri-implant and periodontal plaque score (%);<br /><br>- Marginal soft tissue recession (REC);<br /><br>- Radiographic marginal peri-implant bone level on standardized intraoral<br /><br>radiographs;<br /><br>- Microbiological composition of the peri-implant and periodontal area;<br /><br>- Implant failure, defined as implant mobility of previously clinically<br /><br>osseointegrated implants and removal of non-mobile<br /><br>implants because of progressive marginal bone loss or infection;<br /><br>- Complications and adverse events.</p><br>