Dental Pulp NecrosisNCT00223327
Measurement of Bite Force in Humans
An observational study of Dental Pulp Necrosis and Periapical Periodontitis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This protocol is for a clinical trial to evaluate the reliability of the bite fork as a diagnostic instrument in subjects with pulpal necrosis and apical periodontitis. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Necrosis, Periapical Periodontitis
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to 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
- Healthy volunteers accepted
- Child, Adult
Study population: Normal subjects and patients with orofacial pain presenting in the dental clinic.
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 or premolar
- Diagnosis must be chronic apical periodontitis (CAP) with or without symptoms.
- Intact, mature apices.
- American Society of Anesthesiologists (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 affect their immune system (such as glucocorticoids)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
About this study
This protocol is for a clinical trial to evaluate the reliability of the bite fork as a diagnostic instrument in subjects with pulpal necrosis and apical periodontitis.
Read the detailed description
This clinical trial consists of two parts. We will first use the bite fork in normal volunteers to evaluate its test-retest and inter-rater reliability. We will then use the bite fork in subjects with differing endodontic diagnoses and compare these results with the standard clinical diagnostic test (percussion).
- Conditions
- Dental Pulp Necrosis, Periapical Periodontitis
- Keywords
- pain, Normal pulp and normal periodontal status, Chronic apical periodontitis of pulpal origin
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis, 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 startMar 2005
- 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 Dental Pulp NecrosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asma A Khan, Principal investigator, University of Texas Health Science Center at San Antonio, Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223327
- Sponsor's protocol ID
- 023-1904-101
- 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
- Measurement of Bite Force in Humans
- ClinicalTrials.gov ID
- NCT00223327
- Acronym / sponsor ID
- 023-1904-101
- Conditions
- Dental Pulp Necrosis, Periapical Periodontitis
- Keywords
- pain, Normal pulp and normal periodontal status, Chronic apical periodontitis of pulpal origin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Mar 2005
- 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 protocol is for a clinical trial to evaluate the reliability of the bite fork as a diagnostic instrument in subjects with pulpal necrosis and apical periodontitis.
Detailed description
This clinical trial consists of two parts. We will first use the bite fork in normal volunteers to evaluate its test-retest and inter-rater reliability. We will then use the bite fork in subjects with differing endodontic diagnoses and compare these results with the standard clinical diagnostic test (percussion).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Normal subjects and patients with orofacial pain presenting in the dental clinic.
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 or premolar
- 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 affect 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 Dental Pulp Necrosis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
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 principal investigator
University of Texas Health Science Center at San Antonio, Texas
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 Necrosis and Periapical Periodontitis, 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.