Non-surgical Electrolytic Cleaning Peri-implantitis

Peri-Implantitis Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Peri-Implantitis

• NCT number: NCT05275894
• Study type: Interventional
• Source: Universidad Complutense de Madrid
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 12, 2022
• Completion date: December 30, 2024