Randomised, non-blinded study to investigate the Cleaning of infected implants with GalvoSurge Dental Implant Cleaning System GS 1000” versus air abrasion.

Phase 1

• Conditions: Periimplantitis; K10.9; Disease of jaws, unspecified

• Registration Number: DRKS00015689
• Lead Sponsor: GalvoSurge Dental AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-25
• Study Completion: 2018-11-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

The patient is 18 years or older.
Adequate oral hygiene must have been established (BoP < 20% and Plaque Index < 20%).
The patient is capable of understanding and giving informed consent.
The patient has one or more implants.
At least one implant has a Periimplantitis.
The implant is an Titan-Implant.
The implant has a diameter between 3.5 to 5 mm.
The Titan-implant has one of the following surfaces: machiniert, sandblasting, sandblasting with acid etching.
The Titan implant has Grade 2 / 4 / 5, is anodic oxidated to Titan Grade 4 or plasma sprayed to Grade 4.
The depth of bone defect is < 8 mm
The morphology of defect is augmentable (defect angle < 45°).

Exclusion Criteria

Medical and/or general contraindications for intraoral surgical procedure.
Implants without Periimplantitis.
Titan implants with a diameter < 3.5 mm and > 5 mm.
Ceramic implants.
Titan implants with ceramic coating.
The depth of bone defect is > 8 mm.
The morphology of defect is not augmentable (defect angle >45 °).
Uncontrolled general Periodontitis.
Smoking of =10 cigarettes/day.
Allergy against antibiotics (1st choice amoxicillin-clavulanic acid, 2nd choice clindamycin).
Allergy against local anaesthetics.
Allegy against sodium formate in aqueous solution.
Pregnancy and nursing women.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the safety endpoint. This endpoint is defined<br>by the adverse events based on the individual adverse events<br>reported by the investigator during treatment procedure and by the<br>patient during treatment procedure and in the observation time after<br>completion of treatment (14 days).<br>The character and severity of adverse events are predefined.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint is the efficacy endpoint as defined below.<br>PCR 1 (polymerase chain reaction): after elevation of flap and<br>removing of granulation tissue by smear.<br>PCR 2: after therapy by smear.<br>? number of bacteria PCR1/PCR2 test<br>versus<br>? number of bacteria PCR1/PCR2 control