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

• ClinicalTrials.gov Identifier: NCT03613090
• Recruitment Status: Withdrawn
• First Posted: August 2, 2018
• Last Update Posted: May 23, 2019
• Sponsor: University of Alabama at Birmingham
• Collaborator: Collagen Matrix
• Information provided by (Responsible Party): David Clanton DMD, University of Alabama at Birmingham

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
Root Canal Therapy	Drug: Collagen-hydroxyapatite scaffold (Syn-Oss); Drug: Collagen Scaffold (Colla-Plug)	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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention 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)
• Primary Purpose: Treatment
• Official Title: Novel Collagen Scaffold vs Conventional Scaffold in Regeneration of Human Dental Pulp Tissue
• Estimated Study Start Date: April 1, 2019
• Estimated Primary Completion Date: April 1, 2019
• Estimated Study Completion Date: April 1, 2019

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 :

1. Observation 1-Radiodensity at apex @ 1mm from root vertex [ Time Frame: 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
2. Observation 2 - Increase in dentin wall thickness. It is noted that minimal change is expected over the course of this short-term study. [ Time Frame: 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
3. Observation 3 - Increase in root length, in mm. [ Time Frame: 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
4. Observation 4 - Periradicular status [ Time Frame: 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

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Alabama

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

More Information

• Responsible Party: David Clanton DMD, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03613090
• Other Study ID Numbers: IRB-161031003
• First Posted: August 2, 2018
• Last Update Posted: May 23, 2019
• Last Verified: May 2019

• 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