Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Andrea Ravida
Study ID
NCT06430268
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • implant decontamination with titanium curette — PROCEDURE
    Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implant, with and without flap elevation.
  • implant decontamination with Air-Flow device — DEVICE
    Air-polishing (Airflow Prophylaxis Master, EMS, Nyon, Switzerland) will be carried out with AIR-FLOW powder PLUS (EMS) containing erythritol (sugar alcohol, 14 μm), amorphous silica and 0.3% chlorhexidine to decontaminate implants with and without flap elevation. The device will be adjusted to a power setting of 5 bar static pressure and a maximum level of irrigation with water.

Study Details

This study will compare 2 methods to clean contaminated implant surfaces: air-polishing device versus titanium curette. Both of these methods will be used in the non-surgical and surgical setting, followed by implant removal. Then, in-vitro analysis to assess the efficacy of surface decontamination will be performed.

Key Dates

Start date
May 21, 2024
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Non-surgical decontamination with titanium curettes followed by explantation
    Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants without any flap elevation.
  • Experimental: Non-surgical decontamination with erythritol powder prior to implant removal
    Without any flap elevation, the supramucosal implant surfaces will be cleaned with the Airflow handpiece, while for the submucosal areas, a Perioflow handpiece and nozzle for submucosal instrumentation will be used. The nozzle will be changed after cleaning each implant.
  • Experimental: Surgical decontamination with titanium curettes prior to implant removal
    Intra-sulcular and, if necessary, vertical releasing incisions will be performed. Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed. Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants
  • Experimental: Surgical decontamination with erythritol powder prior to implant removal
    Intra-sulcular and, if necessary, vertical releasing incisions will be performed. Full-thickness flaps will be elevated in the buccal and lingual aspects and the granulation tissue will be removed.The Airflow handpiece will be moved in a horizontal direction along implant threads from an apical to a coronal position. The angulation of the handpiece and working distance will not be standardized as they may vary according to the area being cleaned.
  • No Intervention: No decontamination prior to implant removal
    No decontamination will be performed on implants in this group.

Primary Outcome Measure

Percentage of clean implant surface area following implant decontamination approaches [ Time Frame: Right after decontamination and implant removal (T0) ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh, School of Dental MedicinePittsburghPennsylvania15213-

Find similar trials in Pittsburgh, PA

By research site
University of Pittsburgh, School of Dental Medicine· Pittsburgh, PA

Related Studies