Peri-Implantitis
Conditions
Brief 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 minutes * Control 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.
Interventions
DEVICESurface decontamination procedure aiming at reconstructive therapy
Surface decontamination of infected implants followed by reconstructive therapy to manage peri-implantitis
Sponsors
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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 80 * non-smokers * no presence of systemic disease or medication known to alter bone metabolism * partial or complete edentulous patients that have no active periodontal disease.
Exclusion criteria
* pregnancy or lactation * history of or current smokers * uncontrolled medical conditions, * lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites, * advanced(A) peri-implantitis (\>50% of the implant length).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of the disease | 12 months | No pocket depth \>6mm, no bleeding on probing, no suppuration, no progressive bone loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic bone gain and clinical outcomes | 12 months | Bone gain and changes in defect angle when compared to baseline radiographic features and evolution of clinical parameters compared to baseline data |
Countries
Spain
Outcome results
None listed