on surgical peri-implantitis treatment

Completed

Conditions: Peri-implantitis

Registration Number: NL-OMON23755

Lead Sponsor: niversity Medical Center Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

The patient is = 18 years of age;
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 progressive loss of marginal bone = 2mm, as compared to the baseline radiograph (after placing the definitive restoration) in combination with bleeding and/or suppuration on probing;
The implants have been in function for at least two years;
The patient is capable of understanding and giving informed consent.

Exclusion Criteria

-Medical and general contraindications for the procedures;
-A history of local radiotherapy to the head and neck region;
-Pregnancy and lactation;
-Uncontrolled diabetes mellitus (HbA1c < 7% or < 53 mmol/mol);
-Use of antibiotics during the last 3 months;
-Known allergy to chlorhexidine;
-Long-term use of anti-inflammatory drugs;
-Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
-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;
-Implant mobility;
-Implants at which no position can be identified where proper probing measurements can be performed;
-Previous surgical treatment of the peri-implantitis lesions;
-Previous non-surgical treatment of the peri-implantitis lesions during the last 3 months (scaling or curettage)
-Chronic bronchitis and asthma
-Presents of natural dentition (only for patients in heamatological study)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Mean peri-implant bleeding score (%)<br>- Mean peri-implant and full-mouth periodontal suppuration on probing score (%);<br>- Mean peri-implant and full-mouth periodontal probing pocket depth; <br>- Mean peri-implant and full-mouth periodontal plaque score (%);<br>- mPISA<br>

Secondary Outcome Measures

Name	Time	Method
- Full-mouth periodontal bleeding score;<br>- Marginal soft tissue recession (REC);<br>- Radiographic marginal peri-implant bone level <br>- Microbiological composition of the peri-implant and periodontal area;<br>- Need for additional surgery at teeth and implants;<br>- 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;<br>- Tooth loss, defined as removal of teeth because of progressive marginal bone loss or infection;<br>- Complications and adverse events.<br>- Immunological biomarkers (IL-1b, IL-6, TNFa, MMP8-, MCP-1, MIP1a, OPG, sRANKL, INFgamma, G-CSF)