infecties rondom tand implantaten peri-implant bony defects peri-implant infection
Conditions
Interventions
We will treat 20 test patients with Endobon® Xenograft Granules using a
"non-submerged" regenerative surgical approach according to the specified
procedure, and 20 control patients treated similarly
bone defects
peri-implantitis
regeneration
treatment
Sponsors
Vrije Universiteit
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • During surgical exploration an intra-bony component of at least 3 mm at the deepest point must be present. • The defect should have a minimum of 3 osseous walls (a circumference of the osseous defect of at least 270 degrees). Only 3 and 4 wall intraosseous defects will be included. • The defect must not be wider than 4 mm and the defect angle must be less than 35 degrees from axis of implant.
Exclusion criteria
Exclusion criteria: • Subjects with diabetes mellitus (HbAlc >= 6.5%) • Subjects taking corticosteroids or other anti-inflammatory prescription drug • Subjects taking medications known to induce gingival hyperplasia • Subjects must not be allergic to penicillin or metronidazole • Subjects with a history of taking systemic antibiotics in the preceding month • Subjects must not be pregnant or lactating • Implants placed in grafted bone or previously augmented with bone substitute or other type of regenerative material • If stability of the Endobon® granules or control granules cannot be accomplished in the defect • Failure of obtaining soft tissue closure • Mobile implants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is radiographic vertical reduction of the intra-bony peri-implantitis defects for test and control groups at 6 and 12 months after surgery. The difference in defect fill will be measured on the basis of standardized intra-oral periapical radiographs taken with individualized holders at baseline, and 6 and 12 months after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives to evaluate are: 1) clinical parameters (pocket probing depth [PPD], clinical attachment level [CAL] from stent margin, bleeding on probing, presence /absence pus) 2) patient centered outcomes (subjective satisfaction) 3) graft morbidity 4) esthetics | — |
Countries
The Netherlands
Outcome results
None listed