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Air-polishing in the Treatment of Peri-implantitis

NCT04847648 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-03-13

No results posted yet for this 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.

Conditions

  • Peri-Implantitis

Interventions

PROCEDURE

Air-polishing

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

PROCEDURE

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.

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Principal Investigators

  • Kostas Bougas, PhD · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2025-12-01
Completion
2028-12-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04847648 on ClinicalTrials.gov