Air-polishing in the Treatment of Peri-implantitis

NCT04847648 | Enrolling By Invitation

• 1 other identifier: 2021-00169
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Non-surgical therapy; Surgical therapy; Air abrasives; Air polishing

Outcome Measures

Primary Outcomes (6)

• Proportion of participants/implants displaying pocket closure

  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 months

• Proportion of participants/implants displaying pocket closure

  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

  6 months

• Proportion of participants/implants displaying pocket closure

  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

  18 months

• Patient satisfaction assessed by visual analogue scale

  Patient satisfaction as assessed on a 100 mm VAS

  3 months

• Patient satisfaction assessed by visual analogue scale

  Patient satisfaction as assessed on a 100 mm VAS

  6 months

• Patient satisfaction assessed by visual analogue scale

  Patient satisfaction as assessed on a 100 mm VAS

  18 months

Secondary Outcomes (30)

• Changes in probing pocket depth

  3 months

• Changes in probing pocket depth

  6 months

• Changes in probing pocket depth

  18 months

• Changes in probing pocket depth

  3 years

• Changes in probing pocket depth

  4 years

Study Arms (2)

Control - Mechanical instrumentation of implant surface

ACTIVE COMPARATOR

The control group will be subjected to non-surgical decontamination including the use of hand instruments and polishing cups aiming at the removal of all supra-mucosal soft and hard deposits from the implant surfaces.

Procedure: Mechanical decontamination

Test - Mechanical instrumentation and air-polishing of implant surface

EXPERIMENTAL

In the test group the mechanical instrumentation will be supplemented by the use of an air-polishing device during non-surgical therapy.

Procedure: Air-polishing; Procedure: Mechanical decontamination

Interventions

Air-polishing PROCEDURE

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

Test - Mechanical instrumentation and air-polishing of implant surface

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.

Control - Mechanical instrumentation of implant surface; Test - Mechanical instrumentation and air-polishing of implant surface

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Department of Periodontology, Institute of Odontology

Gothenburg, 40530, Sweden

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Kostas Bougas, PhD

  Göteborg University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical assessments will be performed by assessors unaware of group allocation. Bone level changes over time will be assessed on radiographs and expressed in mm by examiners blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in three clinical centers.

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 19, 2021
• Study Start: October 14, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)