NL-OMON36465
Completed
Phase 3
Regenerative surgical treatment of peri-implantosseous defects - a multicenter randomized prospective clinical study - Peri-implantitis/Tigran study
Academisch Centrum voor Tandheelkunde Amsterdam (ACTA)0 sites12 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- infection of toothimplant surrounding tissues
- Sponsor
- Academisch Centrum voor Tandheelkunde Amsterdam (ACTA)
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient should have;
- •\* A peri\-implant intraosseous defect with at least 3 mm defect depth as seen on an intraoral radiograph.
- •\* Clinically a probing depth \* 5 mm combined with bleeding and/or pus should be present at the site.
- •\* During surgical exploration an intraosseous 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).
- •Implants included in the study must have been in function for more than 12 months.
- •Note: If the same patient has more than one defect meeting the inclusion criteria only one such defects will be included in the study. Other defects will be treated according the standard protocol.
Exclusion Criteria
- •Main exclusion criteria:
- •\* Subjects with diabetes mellitus (HbA1c \>6\.5\)
- •\* Subjects taking corticosteroids or other anti\-inflammatory prescription drugs
- •\* Subjects taking medications known to induce gingival hyperplasia
- •\* Subjects must not be allergic to penicillin
- •\* 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 /bone substitute or other type of regenerative material
- •\* Implants previously treated for peri\-implantitis
- •\* If stability of the titanium granules cannot be accomplished in the defect
Outcomes
Primary Outcomes
Not specified
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