Study Stopped
No advantage seen during continued animal studies. Difficult recruitment.
Revitalization of Teeth With Necrotic Pulps and Open Apexes Using Platelet-Rich Plasma
1 other identifier
observational
10
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2010
CompletedFirst Posted
Study publicly available on registry
October 1, 2010
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 4, 2014
April 1, 2014
1.2 years
September 29, 2010
April 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
stop the infection
6 weeks
Secondary Outcomes (1)
Revitalizing the nerve of the tooth
Every 3-6 months for two years
Eligibility Criteria
All patients between the ages of 6-89
You may qualify if:
- People with necrotic pulp and open apex.
You may not qualify if:
- People with vital pulp and closed apexes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Loma Linda Dental School
Loma Linda, California, 92350, United States
Loma Linda University
Loma Linda, California, 92354, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud Torabinejad, DDS
Loma Linda University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 29, 2010
First Posted
October 1, 2010
Study Start
October 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 4, 2014
Record last verified: 2014-04