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

Phase 2

Withdrawn

Interventions: Drug: Collagen-hydroxyapatite scaffold (Syn-Oss)
Drug: Collagen Scaffold (Colla-Plug)

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Collagen-hydroxyapatite Scaffold (Syn-Oss)	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).
Collagen Scaffold (Colla-Plug)	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.

Primary Outcome Measures

Name	Time	Method
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 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 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
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

Secondary Outcome Measures

Name	Time	Method

Locations (1): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States

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