Novel Collagen Scaffold vs Conventional Scaffold in Regeneration of Human Dental Pulp Tissue
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Observation 1-Radiodensity at apex @ 1mm from root vertex [Month 0-3, Institutional Review Board proposal and approval]
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
- Observation 2 - Increase in dentin wall thickness. It is noted that minimal change is expected over the course of this short-term study. [Months 3-6, patient recruitment and revascularization surgery in Department of Endodontics]
Grade 1 = dentin wall thickness increased by > 1mm Grade 2 = dentin wall thickness < 1mm
- Observation 3 - Increase in root length, in mm. [Month 6-12, clinical and radiographic recall and assessment]
Grade 1 = root length increased > 1 mm Grade 2 = root length increased 0-1 mm Grade 3 = root length shorter than pre-op
- Observation 4 - Periradicular status [Month 13-15, data analysis and manuscript preparation]
Grade 1 = no periradicular radiolucency Grade 2 = periradicular radiolucency 0-1 mm in diameter Grade 3 = periradicular radiolucency > 1 mm in diameter
Eligibility Criteria
Criteria
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:
- Any patients having an American Association of Anesthesiologists 4 health classification will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
Sponsors and Collaborators
- University of Alabama at Birmingham
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-161031003