NCT05275894

Non-surgical Electrolytic Cleaning Peri-implantitis

Non-surgical Treatment of Peri-implantitis With Electrolytic Cleaning: a Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. 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.This is study is a proof of principle study, thus, a case series study is selected to start with. As this is a pilot study to test for the first time the electrolytic cleaning under non-surgical therapy, the sample size has been estimated in a minimum of 25 patients. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do. Therapeutic success is defined as as a composite index (Sanz \& Chapple 2012 criteria of disease resolution) that includes: (1) probing pocket depth \< 5 mm, (2) no bleeding on probing/suppuration and (3) no additional bone loss, at 6 and 12 months). Secondary objectives are: Changes in the clinical outcomes measurements.Changes in the radiological outcomes measurements. Changes in the patient-reported outcomes (PROMs). Evaluation of the outcomes related to the prosthetic restoration. This study will be carried out in the following centers: * Postgraduate Periodontal Clinic at the Faculty of Odontology-Universidad Complutense of Madrid (Spain) * CEOSA-Madrid Private Dental Centre After the non-surgical therapy, patients will be recalled for control visits, with supra- gingival removal of biofilm with air polishing without anaesthesia at: * 3 months. * 6 months. * 12 months. After non-surgical therapy, patients will be included in a strict peri-implant maintenance therapy program to avoid re-contamination of the affected implants. Removal of biofilm with air polishing without anaesthesia and oral hygiene instruction reinforcement will be performed at: 3 months, 6 months, 9 months and 12 months.

Conditions

• Peri-Implantitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-12
• Primary completion: 2024-03-30
• Completion: 2024-12-30
• First posted: 2022-03-11
• Last updated: 2023-11-24

Locations

1 site across 1 country: Spain