Clinical, microbiological and radiographical evaluation of implant surface decontamination using air polishing in the surgical treatment of peri-implantitis; a randomized controlled study

Phase 3

Completed

• Conditions: 10041297; peri-implant disease; peri-implant infection; 10004018

• Registration Number: NL-OMON43273
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-01-22
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 58

Inclusion Criteria

- The patient is * 18 years of age;
- Unsuccessful treatment outcome in non-surgical treatment phase (see concomitant METC proposal). The patient has at least one endosseous implant in the oral cavity with remaining clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as probing pockets depths (PPD) of * 5mm in combination with bleeding and/or suppuration on probing and radiographic bone loss * 2 mm after placing the definitive restoration.
- 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 contra-indications for the procedures;
- A history of local radiotherapy to the head and neck region;
- Pregnancy and lactation;
- Uncontrolled diabetes (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;
- Active periodontal disease at remaining dentition (Probing pocket depth*6mm, bleeding*20%) and/or insufficient oral hygiene (plaque*20%)
- 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;
- Chronic bronchitis and asthma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- 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 and bone defect configuration<br /><br>on standardized intraoral 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 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>