NCT03613090

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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).

Detailed description

Regeneration of pulp tissues in teeth with immature roots is a new concept based on historical limited success using calcium hydroxide dressings placed into debrided pulp spaces. Obtaining stem cells from the apical papilla (SCAP cells), which are present at the base of all teeth, but are most accessible in teeth with immature apices, greatly enhances clinical success. Current therapies lack ideal messenger chemicals and scaffolds to optimize results.

Conditions

• Root Canal Therapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2018-08-02
• Last updated: 2019-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study