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ID
Source
Brief title
Health condition
Peri-implantitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean peri-implant bleeding score (%)
Secondary outcome
Full-mouth periodontal bleeding score;
- Mean peri-implant and full-mouth periodontal suppuration on probing score (%);
- Mean peri-implant and full-mouth periodontal probing pocket depth;
- Mean peri-implant and full-mouth periodontal plaque score (%);
- Marginal soft tissue recession (REC);
- Microbiological composition of the peri-implant and periodontal area;
- Need for additional surgery at teeth and implants;
- 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;
- Tooth loss, defined as removal of teeth because of progressive marginal bone loss or infection;
- Complications and adverse events.
- Patient satisfaction
Background summary
The most effective approach to treat peri-implantitis remains to be found. Recently, a new pocket irrigator/evacuator device, The Fluxion®, based on an alternated interplay between vacuum and fluid (water), has been introduced. A periodontal study showed decreased probing pocket depths and reduced bleeding on probing1. Moreover patients reported less pain after treatment compared to conventional treatment. Whether the pocket irrigator can be used for treatment of peri-implantitis seems unknown.
Study objective
The aim of the present prospective cohort study is to assess the clinical and microbiological effects and patient-reported pain in the non-surgical treatment of peri-implantitis using a pocket irrigator/evacuator device
Study design
Start inclusion; march 2018
Data collection; march 2018 - march 2019
Data analysis; april 2019
Writing manuscript; june 2019
Submission; july 2019
Intervention
All patients receive extensive oral hygiene instructions (using an electric toothbrush, interdental brushes and floss (Oral-B® superfloss or Meridol® floss, at implants in the esthetic zone only) and mechanical non-surgical debridement of the remaining dentition and the supramucosal areas of the implants using ultrasonic instrumentation (EMS®) and hand instruments (scalers and curettes) in one session. The submucosal areas of the infected implants will be irrigated using the Pocketirrigator for 25 seconds per site (4 sites per implant), twice weekly during a period of 3 weeks.
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)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7746 |
| Other | METC UMCG : METC2017.644 |