Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement: A Multicenter Randomized Controlled Trial.

Mimetis Biomaterials S.L.8 sites in 2 countries102 target enrollmentNovember 16, 2017

ConditionsAlveolar Ridge Preservation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Alveolar Ridge Preservation
Sponsor: Mimetis Biomaterials S.L.
Enrollment: 102
Locations: 8
Primary Endpoint: Bone volume changes
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The hypothesis tested in this clinical trial is that a biomimetic synthetic bone graft substitute (MimetikOss, Mimetis Biomaterials) with similar properties to those of human bone can reach a clinical outcome non inferior to that of a deproteinized bovine bone matrix bone graft substitute (Bio-Oss, Geistlisch) in an alveolar ridge preservation procedure followed by implant placement in terms of bone volume changes (primary end point), bone histological observation implant stability and bone level changes (secondary end points).

Registry

clinicaltrials.gov

Start Date

November 16, 2017

End Date

December 15, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Mimetis Biomaterials S.L.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•\>18 years old.
•Able to sign an informed consent form.
•Patients in need of socket preservation presenting 4 wall defects on premolar and molar zone in the maxilla or in the mandible.
•Healthy extraction site (no infected walls).
•The height of root molar bone support must be \> 6 mm. The height of root molar bone support plus the bone height between the most apical root part and the sinus floor must be \> 3 mm. As described in the picture below. Molar roots must be surgically separated previous to extraction
•Only 4 walled defects are included (3mm max of difference between buccal and lingual plate height).
•Presence of opposite occlusal dentition with natural roots in the area intended for extraction and implant placement.
•Natural roots are adjacent to implant site.
•If patient presents more than 1 defect that could be included in the study, only one will be part of the study, the other sites will be treated with the standard of care.
•Patient in good physical health.

Exclusion Criteria

•Patients with premolar extraction due to the root fracture that present infected two wall type defect.
•Patients presenting the defect in the molar and/or premolar region of the maxilla with the concomitant need of sinus lift.
•Absence of adjacent teeth.
•Lack of opposite occluding dentition in the area intended for extraction and subsequent implant placement.
•3 wall (or less) defects.
•Presence of bone dehiscence superior to 3 mm.
•Fenestration in the area intended to treat.
•Prior bone augmentation in the area planned for treatment (i.e ridge preservation).
•History of systemic diseases that would contraindicate oral surgical treatment or any other disease or medication that might have an influence on the involved tissues, such as intake of bisphosphonates, treatment with heparine, osteogenesis imperfecta, osteoporosis etc.
•Autoimmune disease (Rheumatoid polyarthritis, Crohn, Lupus, Sarcoidosis etc).