Clinical trial NCT03613090: Novel Collagen Scaffold vs Conventional Scaffold in Regeneration of Human Dental Pulp Tissue
Official title: Novel Collagen Scaffold vs Conventional Scaffold in Regeneration of Human Dental Pulp Tissue
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Root Canal Therapy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Collagen Matrix
First posted: 2018-08-02
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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:
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Observation 1-Radiodensity at apex @ 1mm from root vertex
timeFrame: Month 0-3, Institutional Review Board proposal and approval
measure: Observation 2 - Increase in dentin wall thickness. It is noted that minimal change is expected over the course of this short-term study.
timeFrame: Months 3-6, patient recruitment and revascularization surgery in Department of Endodontics
measure: Observation 3 - Increase in root length, in mm.
timeFrame: Month 6-12, clinical and radiographic recall and assessment
measure: Observation 4 - Periradicular status
timeFrame: Month 13-15, data analysis and manuscript preparation
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: Univeristy of Alabama at Birmingham
name: David Clanton, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univeristy of Alabama at Birmingham
name: Paul D Eleazer, DDS
role: PRINCIPAL_INVESTIGATOR
References: