Chronic Apical Periodontitis of Pulpal OriginNCT00223470
Cytokine Regulation of Periradicular Pain in Humans
An observational study of Chronic Apical Periodontitis of Pulpal Origin, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This clinical trial evaluates the role of cytokines in patients needing root canal treatment with diagnosis of necrotic pulp and chronic apical periodontitis Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Chronic Apical Periodontitis of Pulpal Origin
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jun 2008
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients presenting to the Endodontics department with an indication for root canal treatment
Who may be able to join
- Patient must be at least 16 years of age.
- Clinical indication for Non-Surgical Root Canal Therapy (NSRCT).
- 1st or 2nd maxillary or mandibular molar
- Diagnosis must be Chronic Apical Periodontitis (CAP) with or without symptoms.
- Intact, mature apices.
- ASA I or II
Who cannot join
- Failure to meet any of the above
- Previous NSRCT
- Previous pulpotomy or pulpectomy
- Suppurative apical periodontitis
- Patients taking medications which can affect their pain rating or medications which effect their immune system ( such as glucocorticoids)
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerity of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
This clinical trial evaluates the role of cytokines in patients needing root canal treatment with diagnosis of necrotic pulp and chronic apical periodontitis
Read the detailed description
This study evaluates whether periradicular exudate concentrations of cytokines differ in patients experiencing pain and mechanical allodynia due to pulpal necrosis with an acute exacerbation of a chronic apical periodontitis, as compared to patients with pulpal necrosis with chronic apical periodontitis, but no pain or mechanical allodynia
- Keywords
- pain
- Medical subject headings
- Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Apical Periodontitis of Pulpal OriginStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Asma A Khan, BDS, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223470
- Sponsor's protocol ID
- 012-1904-455
- Other IDs
- K23DE014864-01A1S1
- Status last verified
- Mar 2012
- First submitted
- 13 Sep 2005
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Regulation of Periradicular Pain in Humans
- ClinicalTrials.gov ID
- NCT00223470
- Acronym / sponsor ID
- 012-1904-455
- Keywords
- pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Oct 2002
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 Sep 2005 (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.
This clinical trial evaluates the role of cytokines in patients needing root canal treatment with diagnosis of necrotic pulp and chronic apical periodontitis
Detailed description
This study evaluates whether periradicular exudate concentrations of cytokines differ in patients experiencing pain and mechanical allodynia due to pulpal necrosis with an acute exacerbation of a chronic apical periodontitis, as compared to patients with pulpal necrosis with chronic apical periodontitis, but no pain or mechanical allodynia
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients presenting to the Endodontics department with an indication for root canal treatment
Key inclusion criteria (6 listed)
- Patient must be at least 16 years of age.
- Clinical indication for Non-Surgical Root Canal Therapy (NSRCT).
- 1st or 2nd maxillary or mandibular molar
- Diagnosis must be Chronic Apical Periodontitis (CAP) with or without symptoms.
- Intact, mature apices.
Key exclusion criteria (5 listed)
- Failure to meet any of the above
- Previous NSRCT
- Previous pulpotomy or pulpectomy
- Suppurative apical periodontitis
- Patients taking medications which can affect their pain rating or medications which effect their immune system ( such as glucocorticoids)
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 9 Mar 2012.
Related trials for Chronic Apical Periodontitis of Pulpal Origin
Not yet recruiting
Using Platelet-rich Fibrin in Regenerative Endodontic Treatment in Mature Permanent Teeth
Chronic Apical Periodontitis, Necrosis of Pulp
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.
Asma A Khan, BDS, 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 Chronic Apical Periodontitis of Pulpal Origin, 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 6 inclusion and 5 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 9 Mar 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 9 Mar 2012.