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Clinical Trials/NL-OMON42142
NL-OMON42142
Completed
Not Applicable

The regenerative surgical treatment of intra-bony peri-implantitis defects with Endobon® (test) versus an established bovine derived bone mineral (control) - Endobon versus BioOss

Vrije Universiteit0 sites40 target enrollmentTBD
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Conditionsinfecties rondom tand implantatenperi-implant bony defectsperi-implant infection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
infecties rondom tand implantaten
Sponsor
Vrije Universiteit
Enrollment
40
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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