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Human Placenta Extract Use in Socket Preservation

NCT06915675 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-11

No results posted yet for this study

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)).

Conditions

  • Dental Extraction

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.

Sponsors & Collaborators

  • botiss biomaterials GmbH

    collaborator UNKNOWN

  • Saint-Joseph University

    lead OTHER

Principal Investigators

  • Ronald Joseph Younes, DDS,MSc, Phd · Saint Joseph University of Beirut

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-23
Primary Completion
2025-02-11
Completion
2025-04-10

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06915675 on ClinicalTrials.gov