Systemic antibiotic therapy (amoxicillin plus metronidazole) as an adjunct to initial non-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;
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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>- Full-mouth periodontal bleeding score;<br /><br>- Mean peri-implant and full-mouth periodontal suppuration on probing score (%);<br /><br>- Mean peri-implant and full-mouth periodontal probing pocket depth;<br /><br>- Mean peri-implant and full-mouth 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>- Need for additional surgery at teeth and implants<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>- Tooth loss, defined as removal of teeth because of progressive marginal bone<br /><br>loss or infection;<br /><br>- Complications and adverse events.</p><br>