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

Root Canal Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03613090
• Other study ID #: IRB-161031003
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: April 1, 2019

Study information

• Verified date: May 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Root Canal Therapy

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Collagen Matrix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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