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ACTIVE NOT RECRUITING
NCT06915675
NA

Human Placenta Extract Use in Socket Preservation

Sponsor: Saint-Joseph University

View on ClinicalTrials.gov

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)).

Official title: The Adjunction of Flowable Decellularized Human Placental Connective Tissue Matrix in Alveolar Ridge Preservation: A Split Mouth Pilot Study

Key Details

Gender

All

Age Range

20 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-08-23

Completion Date

2025-04-10

Last Updated

2025-04-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

Placental Extract

Participants will receive allografts bone substitutes mixed with flowable human placental derived connective tissue matrix in one extraction socket immediately following tooth extraction.

PROCEDURE

Allograft

Participants will receive allografts bone substitutes solely in one extraction socket immediately following tooth extraction.

Locations (1)

Saint Joseph University of Beirut

Beirut, Beyrouth, Lebanon