DRKS00015689CompletedPhase 1
Randomised, non-blinded study to investigate the Cleaning of infected implants with GalvoSurge Dental Implant Cleaning System GS 1000” versus air abrasion. - DICSGS-1
GalvoSurge Dental AG0 sites24 target enrollmentStarted: October 25, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (—)
- Sex
- All
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.
Investigators
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