Peri-Implantitis Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion criteria: (1) 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); (2) Individuals who did not undergo surgical or non-surgical peri-implant therapy in the previous 6 months. Exclusion criteria: (1) Acute infection associated with adjacent teeth; (2) Any technical complication that does not allow implant removal using a reverse torque device; (3) Active infectious diseases of any kind; (4) Medical conditions which requires premedication prior to dental treatments/visits; (5) Pregnant women or planning to become pregnant (self-reported); (6) History of radiotherapy in the head and neck or chemotherapy in the last 3 years; (7) Any other diseases or medications that may contraindicate the surgical procedure or compromise wound healing. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh, School of Dental Medicine | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Andrea Ravida | Association for Dental Infection Control |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | Biocompatibility analysis of the implant | Cultivation of osteoblastic cells will be performed and assessed on the implants. | Right after decontamination and implant removal (T0) | |
Secondary | 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) | |
Secondary | Patient satisfaction with the decontamination devices | Patients will be asked to fill out a questionnaire. | Right after decontamination and implant removal (T0) | |
Secondary | Incidence of complications | Incidence of complications will be recorded by the clinician performing the intervention. | Right after decontamination and implant removal (T0) | |
Secondary | 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) | |
Secondary | Corrosion performance | In vitro electrochemical tests will be conducted to determine the corrosion performance. | Right after decontamination and implant removal (T0) | |
Secondary | 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) |
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