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Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB

NCT06038695 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-06-18

No results posted yet for this study

Summary

The goal of this study is to test a volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB, specifically in patients who have an immediate implant placement for teeth #5-#12.

The main question this study aims to answer is does the recombinant human platelet-derived growth factor-BB accelerate the formation of blood vessels and augment tissue volume around the immediate implant.

Participants will be asked to undergo immediate implant placement using volume-stable collagen matrix in combination with recombinant human platelet-derived growth factor-BB, as well as attend 11 study visits over the course of 1.25 years.

Conditions

  • Tooth Extraction
  • Immediate Implant Placement

Interventions

DEVICE

Xenogeneic Volume-Stable Collagen (VCMX) graft with growth factor-BB

* Fibro-Gide is the Volume-Stable Collagen Matrix. * Recombinant human platelet-derived growth factor-BB will be found within the device of GEM21S.

Sponsors & Collaborators

  • I-Ching Wang

    lead OTHER

Principal Investigators

  • I-Ching Wang, DDS,MS · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

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 NCT06038695 on ClinicalTrials.gov