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Air-polishing in the Treatment of Peri-implantitis

StatusEnrolling by Invitation
PhaseNot applicable
Started2021-10-14
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 1, 2025 → Dec 15, 2026
See other at-risk trials from Göteborg University

Amendment history

2026-09-08
critical
Study Status v7
Primary completion pushed: 2025-12-01 → 2026-12-15
2025-03-11
minor
Study Status, Study Description v6
Study description+14 characters
[...] ntrol group will be subjected to professionally administered non-surgical, mechanical infection control including the use of hand inst [...]
2024-09-25
minor
Study Status v5
Primary completion date2024-03-01→2025-12-01
Completion date2027-10-01→2028-12-01
2023-02-21
minor
Study Status, Study Description, Arms and Interventions v4
Study description-387 characters
[...] ant surfaces will be removed with titanium-coated curettes. Following a second randomization, stratified for smoking, surfaceSurface decontamination will be performed using gauzes soaked in saline in the control group. In the test group, this treatment will be supplemented by air-polishing (AirFlow Handpiece, EMS, Nyon, Switzerland) with erythritol powder (14 mikrometer, AirFlow Plus Powder, EMS, Nyon, Switzerland) at a powerrotating settingtitanium reducedbrush to 60% and followed by carefulunder irrigation with saline. Air polishing will be limited to 60 seconds per implant. No bone recontou [...]
2021-12-07
notable
Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v3
Trial statusRecruiting→Enrolling by Invitation
Start dateestimated 2021-10-15→confirmed 2021-10-14
Study sitesdetails revised at 1 of 1 site
Show 2 earlier versions
2021-10-01
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2021-10-01→2021-10-15
Study sitesdetails revised at 1 of 1 site
2021-07-27
minor
Study Status v1
Primary completion date2023-12-01→2024-03-01
Completion date2027-06-01→2027-10-01
Start date2021-06-01→2021-10-01
2021-04-12
minor
Original filing
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.
Trial Details
NCT Number NCT04847648
Lead Sponsor Göteborg University
Conditions Peri-Implantitis
Enrollment 80 participants
Start Date 2021-10-14
Primary Completion 2026-12-15 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-09