Surgical peri-implantitis therapy by combination of a plasma and a water jet device - Pilot_PeriPLas

Sirona Dental Systems GmbH0 sites61 target enrollmentSeptember 17, 2021

Overview

No summary available.

Registry

who.int

Start Date

September 17, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Sirona Dental Systems GmbH

•1\.Age of the patient \=18 years.
•2\.Patient signed and dated the informed consent form.
•3\.Titanium implant
•4\.Implants must be in place for \= 2 years.
•5\.At least one site with presence of pocket probing depth (PPD) \= 6 mm at selected implant.
•6\.At least one site with BoP (scores 2, 3 and 4, see section 5\.5\.2\.1\) at the selected implant.
•7\.Bone levels \= 3 mm at selected implant apical of the implant\-abutment junction or implant shoulder or in case of tissue level implants of the smooth\-rough transition.
•8\.Sufficient knowledge of German language.

•1\.Unlikely to be able to comply with study procedures, according to Investigator’s judgment.
•2\.Involvement in the planning and conduct of the study or being a dental student or dental professional in a hierarchy dependent position of the participating study center
•3\.Mobility of selected implant.
•4\.Implants with bone loss exceeding 2/3 of the length of the implant.
•5\.Previous surgical peri\-implantitis treatment at selected implant (self\-reported).
•6\.Less than 3 sites can be probed around selected implant.
•7\.Active smokers: only non\-smokers and ex\-smokers are recruited into the study
•8\.Systemic antibiotic treatment (currently or at less than 3 months prior to baseline).
•9\.Requiring anticoagulant treatment (ASS \> 100 mg/day, phenprocoumon, any new oral anticoagulants)
•10\.Long\-term (\> 8 weeks) systemic medication with immunosuppressors, or high doses of corticosteroids (\= 10 mg prednisolon\-equivalent/day) or biologicals (Etanercept, Abatacept and all immunosuppressing (monoclonal) antibodies).