Dental Pulp RegenerationNCT00595595
Development of a Model to Evaluate Regenerative Endodontic Techniques Using Extract Human Teeth
An observational study of Dental Pulp Regeneration and Dental Pulp Diseases, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Millions of teeth are saved each year by root canal therapy. Although current treatment modalities offer high levels of success for many conditions, an ideal form of therapy might consist of regenerative approaches in which diseased or necrotic pulp tissues are removed and replaced with healthy pulp tissue in order to… Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Regeneration, Dental Pulp Diseases
- How many people
- 1,080 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients presenting for surgical removal of impacted teeth
Who may be able to join
- Pre-existing indication for surgical extraction of impacted teeth
- Age 16-65
Who cannot join
- Ages less than 16 or over 65
- No pre-existing indication for surgical extraction of impacted teeth
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Development of a Model to Evaluate Regenerative Endodontic Techniques
Millions of teeth are saved each year by root canal therapy. Although current treatment modalities offer high levels of success for many conditions, an ideal form of therapy might consist of regenerative approaches in which diseased or necrotic pulp tissues are removed and replaced with healthy pulp tissue in order to revitalize teeth.
Read the detailed description
The long term goal of this research project is to develop a method to regenerate dental pulp-like tissue as an alternative method to conventional root canal treatment. The objective of this study is to identify the methods necessary to regenerate dental pulp-like tissue in human teeth. We will collect small (~4X4mm) pieces of oral mucosa that are normally removed during surgical tooth extractions, isolate human postnatal progenitor/stem cells and, using an in vitro cell culture system, combined isolated cells with various scaffolds and test compounds to determine optimal conditions to differentiate pulp-like tissue (eg, odontoblasts, fibroblasts, endothelium, etc) grown in segments of human roots.
- Conditions
- Dental Pulp Regeneration, Dental Pulp Diseases
- Keywords
- Dental Pulp, Regenerative Medicine, Odontoblasts, Stem Cells, Growth factor differentiation of stem/progenitor cells, Odontoblast-specific cell phenotypes
- Medical subject headings
- Dental Pulp Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startFeb 2007
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp RegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio
- Investigators
- Kenneth M Hargreaves, DDS, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595595
- Sponsor's protocol ID
- HSC20070149H
- Status last verified
- Sep 2012
- First submitted
- 7 Jan 2008
- Last updated
- 17 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Model to Evaluate Regenerative Endodontic Techniques
- ClinicalTrials.gov ID
- NCT00595595
- Acronym / sponsor ID
- HSC20070149H
- Conditions
- Dental Pulp Regeneration, Dental Pulp Diseases
- Keywords
- Dental Pulp, Regenerative Medicine, Odontoblasts, Stem Cells, Growth factor differentiation of stem/progenitor cells, Odontoblast-specific cell phenotypes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Millions of teeth are saved each year by root canal therapy. Although current treatment modalities offer high levels of success for many conditions, an ideal form of therapy might consist of regenerative approaches in which diseased or necrotic pulp tissues are removed and replaced with healthy pulp tissue in order to revitalize teeth.
Detailed description
The long term goal of this research project is to develop a method to regenerate dental pulp-like tissue as an alternative method to conventional root canal treatment. The objective of this study is to identify the methods necessary to regenerate dental pulp-like tissue in human teeth. We will collect small (~4X4mm) pieces of oral mucosa that are normally removed during surgical tooth extractions, isolate human postnatal progenitor/stem cells and, using an in vitro cell culture system, combined isolated cells with various scaffolds and test compounds to determine optimal conditions to differentiate pulp-like tissue (eg, odontoblasts, fibroblasts, endothelium, etc) grown in segments of human roots.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting for surgical removal of impacted teeth
Key inclusion criteria (2 listed)
- Pre-existing indication for surgical extraction of impacted teeth
- Age 16-65
Key exclusion criteria (2 listed)
- Ages less than 16 or over 65
- No pre-existing indication for surgical extraction of impacted teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2012.
Related trials for Dental Pulp Regeneration
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Necrotic Immature Permanent Incisors
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Role of GTR on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M Hargreaves, DDS, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Pulp Regeneration and Dental Pulp Diseases, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2012.