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Novel Collagen Scaffold vs Conventional Scaffold in Regeneration of Human Dental Pulp Tissue

NCT03613090 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-05-23

No results posted yet for this study

Summary

The purpose of this investigation is to assess the use of a novel scaffold (an FDA-approved collagen-hydroxyapatite material called Syn-Oss) for regeneration of pulp tissues versus the use of a traditional scaffold (blood clot).

Conditions

  • Root Canal Therapy

Interventions

DRUG

Collagen-hydroxyapatite scaffold (Syn-Oss)

The aim of this study is to add to the existing body of regenerative endodontics research by providing human radiographic evidence for the healing process which occurs after the placement of a FDA-approved collagen-hydroxyapatite scaffold, in the use of a blood clot

DRUG

Collagen Scaffold (Colla-Plug)

Traditionally, endodontic therapy consisted of removing the infected dental pulp from the canal spaces and replacing it with an artificial substitute called gutta percha. Regenerative endodontic research efforts were originally concentrated upon treatment of the immature necrotic tooth whereby stem cells from the bone near the root end were stimulated to grow onto a blood clot scaffold created within the debrided and disinfected canal space. The hope is that the stem cells would differentiate into cells which could potentially replace the lost pulpal tissues, restoring what was lost due to infection.

Sponsors & Collaborators

  • Collagen Matrix

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • David Clanton, DMD · Univeristy of Alabama at Birmingham

  • Paul D Eleazer, DDS · Univeristy of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-04-01
Completion
2019-04-01
FDA Drug
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 NCT03613090 on ClinicalTrials.gov