NCT06430268

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
May 2024Jun 2027

First Submitted

Initial submission to the registry

May 21, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

3.1 years

First QC Date

May 21, 2024

Last Update Submit

June 2, 2025

Conditions

Peri-ImplantitisDental Implant Failed

Keywords

Peri-implantitisDecontaminationImplant Surface

Outcome Measures

Primary Outcomes (1)

  • Percentage of clean implant surface area following implant decontamination approaches

    The cleaned surface area will be planimetrically recorded, and the percentage presence/absence of mineralized deposits as well as scratches on the decontaminated implant surfaces will be determined with the aid of a stereomicroscope.

    Right after decontamination and implant removal (T0)

Secondary Outcomes (8)

  • Bacterial composition of the implants

    Right after decontamination and implant removal (T0)

  • Biocompatibility analysis of the implant

    Right after decontamination and implant removal (T0)

  • Scanning electron microscopy analysis of the cells and residual bacterial deposits

    Right after decontamination and implant removal (T0)

  • Patient satisfaction with the decontamination devices

    Right after decontamination and implant removal (T0)

  • Incidence of complications

    Right after decontamination and implant removal (T0)

  • +3 more secondary outcomes

Study Arms (5)

Non-surgical decontamination with titanium curettes followed by explantation

EXPERIMENTAL

Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants without any flap elevation.

Procedure: implant decontamination with titanium curette

Non-surgical decontamination with erythritol powder prior to implant removal

EXPERIMENTAL

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.

Device: implant decontamination with Air-Flow device

Surgical decontamination with titanium curettes prior to implant removal

EXPERIMENTAL

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

Procedure: implant decontamination with titanium curette

Surgical decontamination with erythritol powder prior to implant removal

EXPERIMENTAL

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.

Device: implant decontamination with Air-Flow device

No decontamination prior to implant removal

NO INTERVENTION

No decontamination will be performed on implants in this group.

Interventions

implant decontamination with titanium curettePROCEDURE

Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implant, with and without flap elevation.

Non-surgical decontamination with titanium curettes followed by explantationSurgical decontamination with titanium curettes prior to implant removal
implant decontamination with Air-Flow deviceDEVICE

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.

Non-surgical decontamination with erythritol powder prior to implant removalSurgical decontamination with erythritol powder prior to implant removal

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult individuals between 18 and 80 years of age who require the explantation of at least one titanium or titanium alloy implant due to severe peri-implantitis (\> 50% bone loss and signs of inflammation);
  • Individuals who did not undergo surgical or non-surgical peri-implant therapy in the previous 6 months.

You may not qualify if:

  • Acute infection associated with adjacent teeth;
  • Any technical complication that does not allow implant removal using a reverse torque device;
  • Active infectious diseases of any kind;
  • Medical conditions which requires premedication prior to dental treatments/visits;
  • Pregnant women or planning to become pregnant (self-reported);
  • History of radiotherapy in the head and neck or chemotherapy in the last 3 years;
  • Any other diseases or medications that may contraindicate the surgical procedure or compromise wound healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh, School of Dental Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Andrea Ravida, DDS MS PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 21, 2024

First Posted

May 28, 2024

Study Start

May 21, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

June 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)