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

NCT03613090 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRB-161031003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Root Canal Therapy

Outcome Measures

Primary Outcomes (4)

• Observation 1-Radiodensity at apex @ 1mm from root vertex

  Grade 1 = no disruption of apical anatomy Grade 2 = Periodontal ligament (PDL) width double thickness, with intact lamina dura Grade 3 = break in lamina dura

  Month 0-3, Institutional Review Board proposal and approval

• Observation 2 - Increase in dentin wall thickness. It is noted that minimal change is expected over the course of this short-term study.

  Grade 1 = dentin wall thickness increased by \> 1mm Grade 2 = dentin wall thickness \< 1mm

  Months 3-6, patient recruitment and revascularization surgery in Department of Endodontics

• Observation 3 - Increase in root length, in mm.

  Grade 1 = root length increased \> 1 mm Grade 2 = root length increased 0-1 mm Grade 3 = root length shorter than pre-op

  Month 6-12, clinical and radiographic recall and assessment

• Observation 4 - Periradicular status

  Grade 1 = no periradicular radiolucency Grade 2 = periradicular radiolucency 0-1 mm in diameter Grade 3 = periradicular radiolucency \> 1 mm in diameter

  Month 13-15, data analysis and manuscript preparation

Study Arms (2)

Collagen-hydroxyapatite Scaffold (Syn-Oss)

EXPERIMENTAL

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).

Drug: Collagen-hydroxyapatite scaffold (Syn-Oss)

Collagen Scaffold (Colla-Plug)

ACTIVE COMPARATOR

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.

Drug: Collagen Scaffold (Colla-Plug)

Interventions

Collagen-hydroxyapatite scaffold (Syn-Oss) 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-hydroxyapatite Scaffold (Syn-Oss)

Collagen Scaffold (Colla-Plug) 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.

Collagen Scaffold (Colla-Plug)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Single root canal space apparent on a standard dental periapical radiograph
• Immature tooth apex width at least 1.1mm in diameter as measured from the radiograph
• No history of antibiotic drug allergy
• Necrotic pulp as demonstrated by coronal discoloration.
• Periapical radiolucency
• Negative pulp sensibility tests
• Other standard clinical means of assessing pulp vitality status

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Collagen Matrix: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Study Officials

• David Clanton, DMD

  Univeristy of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Paul D Eleazer, DDS

  Univeristy of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Investigators will screen routine root canal treatment-seeking patients who present normally to clinic as potential study participants. The patients selected will be those who will require root canal therapy as a part of their routine dental care. Participant will be randomly assigned to one or two groups:

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: August 2, 2018
• Study Start: April 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

US (1)