Air-polishing in the Treatment of Peri-implantitis

Condition(s) studied

Investigational drug(s) / intervention(s)

Air-polishing: Air-polishing with erythritol powder during non-surgical therapy (at baseline, 5 seconds per surface, and, if necessary, at 3 months).

Mechanical decontamination: Mechanical instrumentation of implant surfaces during non-surgical therapy (at baseline and, if necesarry at 3 months) including the use of hand instruments and polishing cups aiming at the removal of all soft and hard deposits from the target implant.

Study summary

The aim of the present study is to evaluate the potential benefit of the adjunctive use of an air-polishing device in the non-surgical treatment of peri-implantitis as compared to mechanical infection control alone. Following establishment of adequate patient-performed infection control, 80 patients diagnosed with moderate/severe peri-implantitis at ≥1 implant will be randomized to one of two groups. Non-surgical will be carried out by experienced operators in three clinical centers and the mechanical instrumentation (control group) will be supplemented by the use of air-polishing with erythritol powder (AirFlow Master, EMS, Nyon, Switzerland) in the test group. The primary outcome assessed is "pocket closure" (ie probing pocket depth ≤5 mm \& absence of profuse bleeding on probing) after 6 months. Secondary outcomes include changes of clinical signs of soft tissue inflammation, adverse events and patient-reported outcome measures. Outcomes of non-surgical therapy will be evaluated at 3 and 6 months. Sites with remaining pathology at 6 months will be subjected to surgical therapy. Patients are then provided with personalized maintenance care and followed up to a 5-year evaluation.

Eligibility

Primary outcome measure(s)

• Proportion of participants/implants displaying pocket closure — 3 months
  Pocket closure: Probing pocket depth of ≤5 mm and absence of bleeding on probing at ≥3 aspects per implant and absence of suppuration on probing
• Proportion of participants/implants displaying pocket closure — 6 months
  Pocket closure: Probing pocket depth of ≤5 mm and absence of bleeding on probing at ≥3 aspects per implant and absence of suppuration on probing
• Proportion of participants/implants displaying pocket closure — 18 months
  Pocket closure: Probing pocket depth of ≤5 mm and absence of bleeding on probing at ≥3 aspects per implant and absence of suppuration on probing
• Patient satisfaction assessed by visual analogue scale — 3 months
  Patient satisfaction as assessed on a 100 mm VAS
• Patient satisfaction assessed by visual analogue scale — 6 months
  Patient satisfaction as assessed on a 100 mm VAS
• Patient satisfaction assessed by visual analogue scale — 18 months
  Patient satisfaction as assessed on a 100 mm VAS

Trial sites (1)

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