Peri-implantitis Oral Health
Conditions
Interventions
Test patients are treated with Endobon® Xenograft Granules using a "non-submerged" regenerative surgical approach according to the specified procedure, and control patients treated similarly with an e
Sponsors
Academic Center for Dentistry Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. During surgical exploration an intra-bony component of at least 3 mm at the deepest point must be present. 2. 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 3. The defect must not be wider than 4 mm and the defect angle must be less than 35 degrees from axis of implant Note: If the same patient has more than one defect meeting the inclusion criteria only one such defect will be included in the study and the other defects will be treated with standard open flap debridement
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus (HbAlc = 6.5%) 2. Taking corticosteroids or other anti-inflammatory prescription drug 3. Taking medications known to induce gingival hyperplasia 4. Allergic to penicillin or metronidazole 5. History of taking systemic antibiotics in the preceding month 6. Pregnant or lactating 7. Stability of the Endobon® granules or control granules cannot be accomplished in the defect 8. Failure of obtaining soft tissue closure 9. Mobile implants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vertical radiographic bone fill of peri-implant intra-bony defects measured on the basis of standardized intraoral periapical radiographs at at baseline, 6 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| All measured at 6 sites/implant at baseline, 6 months and 12 months: 1. Pocket probing depth 2. Bleeding on probing 3. Dichotomous scoring of suppuration (pus) 4. Dichotomous scoring of plaque | — |
Countries
Netherlands
Outcome results
None listed