NCT01212939

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

2 active sites

Status
terminated

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

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2010

Completed
2 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 4, 2014

Status Verified

April 1, 2014

Enrollment Period

1.2 years

First QC Date

September 29, 2010

Last Update Submit

April 3, 2014

Conditions

Keywords

Dead pulps and open root endsPatients who have teeth with dead pulp and open root ends

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

Age6 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Mahmoud Torabinejad, DDS

    Loma Linda University

    PRINCIPAL INVESTIGATOR

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

Locations