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

Efficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants: A Randomized Clinical Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Peri-Implantitis; Dental Implant Failed
• Intervention / Treatment: Procedure: implant decontamination with titanium curette; Device: implant decontamination with Air-Flow device

Detailed Description

A screening visit will be performed to determine the elegibility of the individuals to participate in the study. Information related to the target implant (e.g., brand, material, surface, dimensions, time of function, history of treatment of peri-implantitis) and reconstruction (e.g., cemented or screwed prosthesis, single, multi-unit or full-arch) will be collected. Intra-oral radiographs will be obtained or exported from patients' dental records, and the marginal bone level (MBL) will be measured at the mesial and distal aspects of the implants by one calibrated investigator using an image analysis software (Image J; National Institutes of Health, Bethesda, MD, USA). The anatomy of the bone defect will be determined.

Randomization will be performed in a stratified manner, in sets of 10 implants, by a computer software, to obtain equally balanced groups based on implant characteristics (site, brand, design). A researcher not involved in the clinical interventions will be responsible for randomization.

At the day of implant removal, a single calibrated examiner will assess the following parameters at six sites around each experimental implant using an UNC 15 periodontal probe: (1) Plaque accumulation, using the modified plaque index [mPI]; (2) Probing depth (mm); (3) Bleeding on probing, using the modified gingival index [mGI] ; (4) Suppuration; (5) Recession (mm). The width of keratinized mucosa (KM) will be obtained in the mid-buccal and mid-lingal aspect of the implants (mm). A standard tessellation language (STL) file of the arch of interest using an intraoral optical scanner (Trios 3, 3Shape, Denmark) will be obtained.

Surface decontamination protocols:

All cleaning procedures will be performed without the suprastructures. A notch will be performed on the buccal side of all implant shoulders with the aid of a bur, in order to distinguish the different implant surfaces during the microbiological and biocompatibility analysis phases.

Following local anesthesia, implants will be randomly assigned to the following study groups:

1. Non-surgical decontamination with titanium curettes prior to implant removal (n = 20);
2. Non-surgical decontamination with erythritol powder prior to implant removal (n = 20);
3. Surgical decontamination with titanium curettes prior to implant removal (n = 20);
4. Surgical decontamination with erythritol powder prior to implant removal (n = 20);
5. No decontamination prior to implant removal (n=10).

In the surgical groups, 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.

All giant (visible) calculus will be removed with an ultrasonic tip in advance, without touching the implant surface directly. Copious irrigation with saline will be performed in both groups prior to implant decontamination. All implants will be cleaned by the same operator with the aid of dental surgical loupes. The time needed for the operator to consider the implant surface clean will be recorded.

• Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implants.

• 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. The device will be adjusted to a power setting of 5 bar static pressure and a maximum level of irrigation with water.

  • Non-surgical group: 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.
  • Surgical group: 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.

Implant removal:

Once the decontamination procedure has been completed, all the implants will be explanted with the aid of a reverse torque device (Implant Removal Kit; Zimmer Biomet); no trephines will be used. During the procedure, care will be taken to avoid damage to the implant and its surface. The retrieved implants will be immersed in a transport medium (Dulbecco's Modified Eagle Medium) and stored in sterile plastic vials at 4°C until further analysis.

In all study groups, the explanted sites will be again curetted and the soft tissues will be sutured with interrupted or crossed sutures. Subjects will receive detailed verbal and written postoperative instructions, as well as a prescription for anti-inflammatory medication (ibuprofen [600mg], for 3-5 days, as needed for pain control). Patients will be instructed to rinse gently with 0.12% chlorhexidine twice daily for 1 week. Sutures will be removed after 2 weeks.

Subsequently, a second randomization will take place to direct each implant (n = 10 in each decontamination group) for microbiological/elementary composition analysis and biocompatibility analysis. In-vitro analysis post surface decontamination includes assessing the cleaning efficacy, microbiological analysis, biocompatibility analysis including cultivation of cells, RNA extraction, Reverse Transcription (RT) and Real-Time RT-Polymerase Chain Reaction (Real-Time RT-PCR) , and elementary composition analysis including implant surface degradation, corrosion performance and atomic composition.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh, School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: implant decontamination with titanium curette; Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implant, with and without flap elevation.
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	Procedure: implant decontamination with titanium curette; Titanium curettes (Hu-Friedy, Chicago, Illinois, USA) will be used for supra and submucosal around the implant, with and without flap elevation.
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.	Device: implant decontamination with Air-Flow 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.
No Intervention: No decontamination prior to implant removal; No decontamination will be performed on implants in this group.
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.	Device: implant decontamination with Air-Flow 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial composition of the implants	Shotgun metagenomic sequencing will be used to identify the bacterial composition in the residual biofilms.	Right after decontamination and implant removal (T0)
Biocompatibility analysis of the implant	Cultivation of osteoblastic cells will be performed and assessed on the implants.	Right after decontamination and implant removal (T0)
Scanning electron microscopy analysis of the cells and residual bacterial deposits	SEM images of the surfaces of negative control implants (brand new) and treated implants for each decontamination method will be exemplarily taken after instrumentation and cell culture.	Right after decontamination and implant removal (T0)
Patient satisfaction with the decontamination devices	Patients will be asked to fill out a questionnaire.	Right after decontamination and implant removal (T0)
Incidence of complications	Incidence of complications will be recorded by the clinician performing the intervention.	Right after decontamination and implant removal (T0)
Implant surface degradation	Three-dimensional images and roughness line profiles will be acquired by laser scanning confocal microscopy.	Right after decontamination and implant removal (T0)
Corrosion performance	In vitro electrochemical tests will be conducted to determine the corrosion performance.	Right after decontamination and implant removal (T0)
Atomic composition of the implants after removal	The atomic composition of the surface of the decontaminated implants will be examined using energy-dispersive x-ray spectroscopy (EDS).	Right after decontamination and implant removal (T0)

Collaborators and Investigators

• Sponsor: Andrea Ravida
• Collaborators: Association for Dental Infection Control
• Investigators: Principal Investigator: Andrea Ravida, DDS MS PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Peri-implantitis; Decontamination; Implant Surface
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Peri-Implantitis
• Other Study ID Numbers: STUDY23100029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No