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

NCT ID: NCT03613090

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-04-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Collagen-hydroxyapatite Scaffold (Syn-Oss)

Placement of a collagen-hydroxyapatite scaffold (Syn-Oss), placement of a tricalcium silicate barrier (mineral trioxide aggregate), placement of a composite occlusal restoration (standard dental material).

Group Type: EXPERIMENTAL

Collagen-hydroxyapatite scaffold (Syn-Oss)

Intervention Type: DRUG

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

Collagen Scaffold (Colla-Plug)

Placement of a collagen scaffold (Colla-Plug) over a blood clot, placement of a tricalcium silicate barrier (mineral trioxide aggregate), placement of a composite occlusal restoration (standard dental material). The Colla-Plug material is placed adjacent to the blood clot that has formed inside the root canal space. It act as a matrix for the subsequent placement of the mineral trioxide aggregate material. It has been used as the standard of care in regenerative endodontics since 2004.

Group Type: ACTIVE_COMPARATOR

Collagen Scaffold (Colla-Plug)

Intervention Type: DRUG

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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Single root canal space apparent on a standard dental periapical radiograph

2. Immature tooth apex width at least 1.1mm in diameter as measured from the radiograph

3. No history of antibiotic drug allergy

4. Necrotic pulp as demonstrated by coronal discoloration.

5. Periapical radiolucency

6. Negative pulp sensibility tests

7. Other standard clinical means of assessing pulp vitality status

Exclusion Criteria

1. Any patients having an American Association of Anesthesiologists 4 health classification will be excluded.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Collagen Matrix

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

David Clanton DMD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Clanton, DMD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Alabama at Birmingham

Paul D Eleazer, DDS

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-161031003

Identifier Type: -

Identifier Source: org_study_id