Clinical and microbiological effect of submucosal irrigation with the Pocketirrigator for treatment of peri-implantitis

Completed

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

• Registration Number: NL-OMON53366
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-06-12
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

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 (Lang and Berglundh 2011);
- 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;
- Uncontrolled diabetes (HbA1c < 7% or < 53 mmol/mol);
- Smoking
- Use of antibiotics during the last 3 months;
- Long-term use of anti-inflammatory drugs;
- Active periodontitis of the remaining dentition (PPD > 5 mm);
- 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 treatment of the peri-implantitis lesions during the last 3 months (scaling or curettage).

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>- 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.<br /><br>- Patient satisfaction</p><br>