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

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).

Study Overview

• Status: Withdrawn
• Conditions: Root Canal Therapy
• Intervention / Treatment: Drug: Collagen-hydroxyapatite scaffold (Syn-Oss); Drug: Collagen Scaffold (Colla-Plug)

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	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
ACTIVE_COMPARATOR: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Collagen Matrix
• Investigators: Principal Investigator: David Clanton, DMD, Univeristy of Alabama at Birmingham; Principal Investigator: Paul D Eleazer, DDS, Univeristy of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2019
• Primary Completion (ANTICIPATED): April 1, 2019
• Study Completion (ANTICIPATED): April 1, 2019

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (ACTUAL): August 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB-161031003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No