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Clinical Trial Summary

The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing MinerOss® X Plug with and without Striate+ Membrane to maintain ridge dimension after a tooth extraction.


Clinical Trial Description

The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing two widely accepted treatment modalities that are used to maintain ridge dimension after a tooth extraction. The specific aims of the study are: 1. To demonstrate the efficacy of a Striate+ membrane in conjunction with a bone graft substitute for providing hard tissue regeneration in the socket preservation procedure. 2. To determine the safety of Striate+ membrane when primary flap closure over the membrane is not achieved in the socket preservation procedure. 3. To provide detailed evidence of new bone formation in patients undergoing socket preservation procedures by means of clinical, radiographic, histologic, and histomorphometric analyses. It is currently unclear if one treatment is more effective than the other. The two treatments being compared are: Treatment 1: Socket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10) Treatment 2: Socket preservation sites with bone graft (MinerOss® X Plug) and a non-crosslinked collagen membrane without complete flap closure (secondary intention healing) (n=10) MinerOss® X Plug: A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen. The 20% collagen prevents particulate migration. Striate+ Membrane: A non-crosslinked collagen covering used to keep bacteria out and hold the bone graft in place. Secondary intention healing (without complete flap closure): The wound edges are not brought together (i.e. knee scrape). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05838651
Study type Interventional
Source Harvard School of Dental Medicine
Contact David M Kim, DDS, DMSc
Phone 617-432-1472
Email dkim@hsdm.harvard.edu
Status Not yet recruiting
Phase N/A
Start date May 2023
Completion date May 2025

See also
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Active, not recruiting NCT06251960 - Demineralized Dentin Graft in Preservation of Post-Extraction Sites Associated With Delayed Implant Placement N/A
Recruiting NCT05613075 - Effect of Locally Applied Hyaluronic Acid, Mixed With Autogenous Demineralized Tooth Graft, for Socket Preservation, Versus Autogenous De-mineralized Tooth Graft. N/A
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