Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT04847648

Air-polishing in the Treatment of Peri-implantitis

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology, Institute of Odontology

Gothenburg, 40530, Sweden

About this study

The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in three clinical centers. 80 systemically healthy patients diagnosed with moderate/severe peri-implantitis at ≥1 implant will be enrolled.

Upon enrolment, all patients will receive instructions in oral hygiene measures until adequate plaque control has been established (Plaque Index ≤20%). If required, supraconstructions will be adjusted to facilitate adequate oral hygiene measures. Thereafter, study participants will be randomized into two groups, stratified for smoking (yes/no) and number of implants in need of treatment (single/multiple).

The control group will be subjected to professionally administered non-surgical, mechanical infection control including the use of hand instruments and polishing cups aiming at the removal of all supra-mucosal soft and hard deposits from the target sites. In the test group the aforementioned treatment will be supplemented by the use of an air-polishing device (AirFlow Master, EMS, Nyon, Switzerland) with a specially designed nozzle for sub-mucosal application (PerioFlow Handpiece, EMS, Nyon, Switzerland). Following local anesthesia, the instrument will be used sub-mucosally at all aspects (ie mesial, distal, buccal, lingual) of the affected implant(s) at a power setting reduced to 60% and with a erythritol powder (14 mikrometer, AirFlow Plus Powder, EMS, Nyon, Switzerland). The handpiece will be guided in a circular motion in a corono-apical direction not in contact with the implant surface. Instrumentation time will be limited to 5 seconds at each aspect. Implant-supported supraconstructions will not be removed for the non-surgical treatment. Patients are recalled two weeks later for assessment of patient-experienced outcomes, professional supramucosal cleaning and reinforcement of oral hygiene.

Peri-implant soft tissues will be evaluated at three months. Implant sites with remaining signs of pathology (PPD ≥6 mm and presence of BOP at ≥3 aspects per implant will be subjected to re-treatment according to the initial allocation. The clinical evaluation will be repeated at 6 months. In case of residual signs of pathology, affected sites will be subjected to surgical therapy of peri-implantitis within the subsequent 4 weeks. Full thickness flaps will be elevated and inflamed tissues will be removed. Mineralized deposits on the implant surfaces will be removed with titanium-coated curettes. Surface decontamination will be performed using a rotating titanium brush under irrigation with saline. No bone recontouring of bony walls is intended. Flaps will be sutured to the level of the bone and sutures will be removed after 2 weeks. Implant-supported supraconstructions will be removed for the surgical intervention, if possible.

Maintenance therapy will be provided at 9 and 12 months and based on individual needs during the subsequent follow-up. A renewed evaluation will be performed at 12 and 18 months. Long-term assessments will be carried out annually from years 3 to 5. Should any implant site present with signs of disease progression (increase of PPD >2 mm and additional bone loss >1 mm compared to baseline) at any of the follow-up examinations, the implant will be exited from the study and appropriate additional therapy will be provided.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Probing pocket depth of ≥6 mm
  • Bleeding and/or suppuration on probing at ≥3 aspects per implant
  • Documented radiographic bone loss of ≥2 mm.

Exclusion criteria

  • Implants with bone loss ≥80% of implant length will not be considered.
  • No medical conditions prohibiting non-surgical/surgical treatment of peri-implantitis
  • Implant(s) in function ≥1 year

Treatment and study plan

Air-polishing

Procedure

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

Mechanical decontamination

Procedure

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.

Primary outcomes

  1. Proportion of participants/implants displaying pocket closure

    Time frame: 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

  2. Proportion of participants/implants displaying pocket closure

    Time frame: 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

  3. Proportion of participants/implants displaying pocket closure

    Time frame: 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

  4. Patient satisfaction assessed by visual analogue scale

    Time frame: 3 months

    Patient satisfaction as assessed on a 100 mm VAS

  5. Patient satisfaction assessed by visual analogue scale

    Time frame: 6 months

    Patient satisfaction as assessed on a 100 mm VAS

  6. Patient satisfaction assessed by visual analogue scale

    Time frame: 18 months

    Patient satisfaction as assessed on a 100 mm VAS

Secondary outcomes

  1. Changes in probing pocket depth

    Time frame: 3 months

    Reductions in PPD relative to baseline

  2. Changes in probing pocket depth

    Time frame: 6 months

    Reductions in PPD relative to baseline

  3. Changes in probing pocket depth

    Time frame: 18 months

    Reductions in PPD relative to baseline

  4. Changes in probing pocket depth

    Time frame: 3 years

    Reductions in PPD relative to baseline

  5. Changes in probing pocket depth

    Time frame: 4 years

    Reductions in PPD relative to baseline

  6. Changes in probing pocket depth

    Time frame: 5 years

    Reductions in PPD relative to baseline

  7. Changes in bleeding on probing

    Time frame: 3 months

    Reductions in BOP relative to baseline

  8. Changes in bleeding on probing

    Time frame: 6 months

    Reductions in BOP relative to baseline

  9. Changes in bleeding on probing

    Time frame: 18 months

    Reductions in BOP relative to baseline

  10. Changes in bleeding on probing

    Time frame: 3 years

    Reductions in BOP relative to baseline

  11. Changes in bleeding on probing

    Time frame: 4 years

    Reductions in BOP relative to baseline

  12. Changes in bleeding on probing

    Time frame: 5 years

    Reductions in BOP relative to baseline

  13. Changes in marginal soft soft tissue levels

    Time frame: 3 months

    Changes in marginal soft soft tissue levels relative to baseline

  14. Changes in marginal soft soft tissue levels

    Time frame: 6 months

    Changes in marginal soft soft tissue levels relative to baseline

  15. Changes in marginal soft soft tissue levels

    Time frame: 18 months

    Changes in marginal soft soft tissue levels relative to baseline

  16. Changes in marginal soft soft tissue levels

    Time frame: 3 years

    Changes in marginal soft soft tissue levels relative to baseline

  17. Changes in marginal soft soft tissue levels

    Time frame: 4 years

    Changes in marginal soft soft tissue levels relative to baseline

  18. Changes in marginal soft soft tissue levels

    Time frame: 5 years

    Changes in marginal soft soft tissue levels relative to baseline

  19. Changes in radiographic bone levels

    Time frame: 6 months

    Changes in radiographic bone levels relative to baseline

  20. Changes in radiographic bone levels

    Time frame: 18 months

    Changes in radiographic bone levels relative to baseline

  21. Changes in radiographic bone levels

    Time frame: 3 years

    Changes in radiographic bone levels relative to baseline

  22. Changes in radiographic bone levels

    Time frame: 5 years

    Changes in radiographic bone levels relative to baseline

  23. Rate of adverse events

    Time frame: 3 months

    Emphysema

  24. Rate of adverse events

    Time frame: 6 months

    Emphysema

  25. Rate of adverse events

    Time frame: 18 months

    Emphysema

  26. Patient discomfort as expressed on a visual analogue scale

    Time frame: 3.5 months

    Patient discomfort 2 weeks after non-surgical treatment as expressed on a 100 mm VAS

  27. Patient discomfort as expressed on a visual analogue scale

    Time frame: 6.5 months

    Patient discomfort 2 weeks after surgical treatment as expressed on a 100 mm VAS

  28. Esthetic appreciation as expressed on a visual analogue scale

    Time frame: 3 months

    Esthetic appreciation as expressed on a 100 mm VAS

  29. Esthetic appreciation as expressed on a visual analogue scale

    Time frame: 6 months

    Esthetic appreciation as expressed on a 100 mm VAS

  30. Esthetic appreciation as expressed on a visual analogue scale

    Time frame: 18 months

    Esthetic appreciation as expressed on a 100 mm VAS

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

Air-polishing in the Treatment of Peri-implantitis - a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2025
Study completion
2028
First posted
Apr 19, 2021
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.