Endodontic Regenerative Procedure for Immature Non-vital Teeth
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 7 - 18 |
| Updated: | 3/21/2019 |
| Start Date: | April 2019 |
| End Date: | January 2023 |
| Contact: | Jacob Al-Hashemi, DDS |
| Email: | jhashemi@bu.edu |
| Phone: | 857-241-0511 |
In this clinical trial the investigators will evaluate an alternate treatment option, which
was developed for teeth with incomplete roots, called Regenerative Endodontic Procedure
(REP). This treatment works by harnessing the blood clot formed within the root canal from
tissues surrounding the root as a scaffold for stem cells. These cells could help to increase
the thickness and length of the root canal walls resulting in root end maturation.
Results from the 50 participants who will receive the REP treatment will be compared with
findings with historical data.
was developed for teeth with incomplete roots, called Regenerative Endodontic Procedure
(REP). This treatment works by harnessing the blood clot formed within the root canal from
tissues surrounding the root as a scaffold for stem cells. These cells could help to increase
the thickness and length of the root canal walls resulting in root end maturation.
Results from the 50 participants who will receive the REP treatment will be compared with
findings with historical data.
All participants will be prospectively assigned to the REP treatment group. Results from the
treatment group will be compared to historical controls of all subjects treated by Ca(OH)2 or
MTA apexification in the last 10 years (2007-2017) at the Boston University Henry M Goldman
School of Dental Medicine.
All materials used in this protocol are FDA approved and commercially available for similar
applications. This study does not seek a new use or application of any materials, instead
recommendations of the American Association of Endodontists (AAE) will be followed to
evaluate outcomes associated with the REP compare to the standard of care Ca(OH)2 or MTA
apexification.
The overall objective for this research is the elimination of any clinical symptoms and the
evidence of bony healing as examined by radiographs.
Other objectives include increased root wall thickness and/or increased root length and
positive response to vitality testing, which if achieved, could indicate a more organized
vital pulp tissue.
treatment group will be compared to historical controls of all subjects treated by Ca(OH)2 or
MTA apexification in the last 10 years (2007-2017) at the Boston University Henry M Goldman
School of Dental Medicine.
All materials used in this protocol are FDA approved and commercially available for similar
applications. This study does not seek a new use or application of any materials, instead
recommendations of the American Association of Endodontists (AAE) will be followed to
evaluate outcomes associated with the REP compare to the standard of care Ca(OH)2 or MTA
apexification.
The overall objective for this research is the elimination of any clinical symptoms and the
evidence of bony healing as examined by radiographs.
Other objectives include increased root wall thickness and/or increased root length and
positive response to vitality testing, which if achieved, could indicate a more organized
vital pulp tissue.
Inclusion Criteria:
Subjects followed prospectively
- 7-18 years old
- salvageable permanent non-vital tooth with immature apex whether anterior or posterior
- receiving dental care at the Henry M. Goldman School of Dentistry Historical controls
- 7-18 year old
- salvageable permanent non-vital tooth with immature apex whether anterior or posterior
- received care and has accessible records at the Henry M. Goldman School of Dentistry
- had either the Calcium hydroxide apexification or MTA apexification between 2007 and
2017
Exclusion Criteria:
- allergic to medications necessary to complete procedure
- health status not in: a) ASA-1 no organic pathology or patients in whom the
pathological process is localized and does not cause any systemic disturbance or
abnormality; nor b) ASA 2 A moderate but definite systemic disturbance, caused either
by the condition that is to be treated or surgical intervention or which is caused by
other existing pathological processes
- history of dental trauma within 6 months due to possibility of internal and external
root resorption.
- if tooth pulp space is needed for post/core final restoration
- pregnancy in female subjects
We found this trial at
1
site
100 East Newton Street
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Phone: 617-638-6613
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