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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Root Canal Therapy

Intervention / Treatment
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* Drug: Collagen-hydroxyapatite scaffold (Syn-Oss)
* Drug: Collagen Scaffold (Colla-Plug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 1. Any patients having an American Association of Anesthesiologists 4 health classification will be excluded.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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:
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagen-hydroxyapatite Scaffold (Syn-Oss)<br>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)<br>* 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<br>|
| Active Comparator: Collagen Scaffold (Colla-Plug)<br>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)<br>* 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.<br>|

What is the study measuring?
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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 |