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NCT05615051
Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis
Conditions: Peri-Implantitis
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 60
Sponsor: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Location: Spain
Summary
Two groups are aimed at being investigated in three centers (CICOM, Clinica Branemark and Clinica Joan Pi)Test group: Group electrolytic approach (EA): Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutesControl group: Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze Patients´ group selection will be randomly allocated.
For patients whom their personal clinical record # ends in a number from 0 to 4 will be included in the test group, while for patients whom their personal clinical record # ends from 5-9 will be included in the control group.The infra-osseous component will be regenerated using xenograft (Creos, NB) + autogenous bone in a ratio 1:1 harvested from the adjacent area.
A resorbable membrane (Creos, NB) will be placed to compartmentalize the infra-osseous component following a poncho-like approach.
Eligibility Criteria
Inclusion:Screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months.All patients in age of 18 to 80non-smokersno presence of systemic disease or medication known to alter bone metabolismpartial or complete edentulous patients that have no active periodontal disease.Exclusion criteria:pregnancy or lactationhistory of or current smokersuncontrolled medical conditions,lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites,advanced(A) peri-implantitis (>50% of the implant length).
Source: ClinicalTrials.gov (NCT05615051). StuddyBuddy aggregates publicly available trial information.