Clinical Trial

Human Placenta Extract Use in Socket Preservation

Active, Not Recruiting
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Summary
This split-mouth pilot study evaluates the effectiveness of flowable decellularized Human Placental Connective Tissue Matrix (HPCTM) in alveolar ridge preservation following tooth extraction. Patients will receive HPCTM mixed with allograft particles in one extraction socket and allograft particles solely in the contralateral socket. The primary outcome is to assess dimensional changes in the alveolar ridge in terms of soft tissue shrinkage using a super-imposed intra-oral scans taken at baseline , day 10, 21 and 30 post-op and bone resorption rate by comparing pre-op and 4 months post-op cone beam computed tomography scans. Secondary outcomes include clinical soft tissue healing evaluation and commentary. The HPCTM used in this study is regulated by the US FDA under Section 361 of the Public Health Service Act (21 CFR Part 1271.10(a)).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-04.
Trial Details
NCT Number NCT06915675
Lead Sponsor Saint-Joseph University
Collaborators: Botiss Biomaterials GmbH
Conditions Dental Extraction
Enrollment 10 participants
Start Date 2024-08-23
Primary Completion 2025-02-11 (estimated)
Study Completion 2025-04-10 (estimated)
Updated on ClinicalTrials.gov 2025-04-11