Non-surgical Electrolytic Cleaning Peri-implantitis

NCT05275894 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-11-24

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05275894 on ClinicalTrials.gov