Revitalization of Teeth With Necrotic Pulps and Open Apexes Using Platelet-Rich Plasma

This study has been terminated.
(No advantage seen during continued animal studies. Difficult recruitment.)
Sponsor:
Information provided by (Responsible Party):
Torabinejad, Mahmoud, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01212939
First received: September 29, 2010
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

When root canals of infected teeth with closed ends are cleaned, disinfected and filled, the results are predictable with excellent outcomes. However, in a tooth with incomplete root development, the end of the root(s) must be closed before filling the root canals. One or two-step artificial barrier using mineral trioxide aggregate (MTA) has been used before filling the root canals of these teeth. Despite the high success of this treatment, this procedure does not result in complete root formation and these teeth are susceptible to root fracture. A number of case reports in scientific journal have shown the possibility for regeneration of nerve within the root canal space and continued root development in teeth with dead nerves and open ends. There is very little information regarding the use of stem cells and growth factors from the blood of patients to regenerate the nerves in these teeth. Platelet rich plasma (PRP) from whole blood has been mentioned in the literature as a potential ideal material for regeneration of nerves in these teeth. The purpose of this study is to investigate the use of PRP to regenerate tooth nerve and close the root ends in teeth with root canal infection and open root ends.


Condition
Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Revitalization of Teeth With Necrotic Pulps and Open Apexes Using Platelet-Rich Plasma

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • stop the infection [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Revitalizing the nerve of the tooth [ Time Frame: Every 3-6 months for two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients between the ages of 6-89

Criteria

Inclusion Criteria:

  • People with necrotic pulp and open apex.

Exclusion Criteria:

  • People with vital pulp and closed apexes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212939

Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Loma Linda Dental School
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Torabinejad, Mahmoud
Investigators
Principal Investigator: Mahmoud Torabinejad, DDS Loma Linda University
  More Information

No publications provided

Responsible Party: Torabinejad, Mahmoud, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT01212939     History of Changes
Other Study ID Numbers: IRB# 5100239
Study First Received: September 29, 2010
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Dead pulps and open root ends
Patients who have teeth with dead pulp and open root ends

Additional relevant MeSH terms:
Dental Pulp Necrosis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014