Effect of adjunctive electrochemical implant surface decontamination in the treatment of periimplantitis: A randomised controlled clinical trial

Not Applicable

Recruiting

• Conditions: T84.7; Infection and inflammatory reaction due to other internal orthopaedic prosthetic devices, implants and grafts

• Registration Number: DRKS00033883
• Lead Sponsor: Mund-Kiefer-Gesichtschirurgie des Klinikums der Universität München LM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Medically healthy adult (ASA classification I-II, age = 18 years old)
-Non-smoker
-Good oral hygiene (FMPS & FMBS = 25 %)
-Patient willing to give written informed consent
-Ability and willingness to follow study procedures
-periodontally without pathological findings or successfully treated
-implants with unresolved periimplantitis as defined by the 2018 World Workshop (Stefan Renvert et al., 2018):
1.Evidence of visual inflammatory changes in the peri-implant soft tissues combined with bleeding on probing and/or suppuration
2.Increasing probing pocket depths as compared to measurements obtained at placement of the supra-structure; and
3.Progressive bone loss in relation to the radiographic bone level assessment at 1 year following the delivery of the implant-supported prosthetics reconstruction; and
4.In the absence of initial radiographs and probing depths, radiographic evidence of bone level =3 mm and/or probing depths =6 mm in conjunction with profuse bleeding represents peri-implantitis
-more than 2mm keratinized and at the same time attached periimplant mucosa

Exclusion Criteria

-Pregnant, intending to conceive or breast feeding
-hematologic diseases, immunosuppression and collagenosis
-untreated periodontitis
-No written informed consent
-Implant mobility
-irrational to treat (bone loss around the implant >75% or less <3mm remaining periimplant bone)
-less than 2mm keratinized periimplant mucosa
-less than 2mm attached periimplant mucosa

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-treatment success = absence of periimplantitis according to Herrera et. al. 2023<br>-implant survival

Secondary Outcome Measures

Name	Time	Method
-periimplant mucositis<br>-probing pocket depths