Microbiological and clinical evaluation of different implant surface decontaminating procedures in the surgical treatment of peri-implantitis; a double blind placebo controlled randomized clinical study.

Completed

• Conditions: infection of the gingiva surrounding a dental implant; peri-implantitis; 10004018

• Registration Number: NL-OMON33406
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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 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

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) 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 remaining dentition;
9) Local use of antibiotics or use of other anti-septic / antimicrobial therapies in the oral cavity during the last 3 months;
10) Use of mouthrinses;
11) Bruxism;
12) Implants placed in skin grafted areas;
13) Implants with bone loss due to other reasons than bacterial infection (e.g. loose screw, inadequate positioning of the implant);
14) Implants with bone loss exceding 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 postition 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 parameters is microbial composition of the biofilm covering the<br /><br>dental implant surface.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters are:<br /><br>- Modified bleeding index<br /><br>- Probing pocket depth<br /><br>- Suppuration on probing<br /><br>- Microbiological composition of the peri-implant sulcus<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<br /><br>- Patient satisfaction</p><br>