Non-surgical Electrolytic Cleaning Peri-implantitis
NCT05275894 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2023-11-24
Summary
Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis.
A prospective clinical and radiographic case series study will be performed to evaluate the clinical performance of the adjunctive use of electrolytic cleaning as an adjunct to a non-surgical therapy protocol that includes curettage of the peri-implant soft tissue. This is study is a proof of principle study, thus, a case series study is selected to start with. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do.
Conditions
- Peri-Implantitis
Interventions
- BEHAVIORAL
-
Implant hygiene instructions and removal of the prosthesis
Verbal instructions on implant hygiene practices and removal of the implant supported prosthesis
- PROCEDURE
-
Non-surgical peri-implantitis treatment /microsurgery
Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA) after applying local anestesia
- PROCEDURE
-
Implant surface decontamination 1(ultrasonic device)
Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
- PROCEDURE
-
Implant surface decontamination 2 (air polishing)
Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).
- PROCEDURE
-
Implant surface decontamination 3 (electrolytic cleaning)
Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.
- DRUG
-
Antibiotic treatment (Metronidazole)
Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
- PROCEDURE
-
Modification and polishing of the prosthesis
If necessary, modification and polishing of the prosthesis to make it cleanable.
Sponsors & Collaborators
-
Universidad Complutense de Madrid
lead OTHER
Principal Investigators
-
Mariano Sanz Alonso · University Complutense Madrid
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-12
- Primary Completion
- 2024-03-30
- Completion
- 2024-12-30
Countries
- Spain
Study Locations
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