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Safety and Efficacy Evaluation of the Ivory Dentin Graft Device (IvoryGraft) - Long Term Follow-Up

NCT04868825 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-05-03

No results posted yet for this study

Summary

long-term safety and performance of Ivory Dentin Graft. Ivory Dentin Graft is at least as good as the competitor treatment group (OsteoBiol Gen-Os) for alveolar ridge preservation following tooth extraction.

Conditions

  • Deficiency of Alveolar Ridge (Disorder)
  • Alveolar Bone Grafting
  • Mandibular Prosthesis User

Interventions

DEVICE

Ivory Dentin Graft

Ivory Dentin Graft is a bone graft material for the repair or augmentation of bone defects in dental procedures. It consists of sterile 300 - 900 μm porous particles or granules of hydroxyapatite and collagen which retain the natural form of the source porcine dentin and protein matrix. (Packed Vial: 1.00 gr; Packed Syringe: 1.0 gr)

DEVICE

OsteoBiol Gen-Os

Comparator control device A natural porcine origin cortico-cancellous heterologous bone mix consists of sterile 250 - 1000 μm porous particles of hydroxyapatite and collagen (Packed Vial: 1.0 gr)

Sponsors & Collaborators

  • Ivory Graft Ltd.

    lead INDUSTRY

Principal Investigators

  • Tal Lavi, PhD · Ivory Graft Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-07
Primary Completion
2025-01-10
Completion
2025-04-01

Countries

  • Israel

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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 NCT04868825 on ClinicalTrials.gov