Tooth PainCohort DentalNCT01268436
Cohort Comparison of Dental Nerve Block With Other Forms of Analgesia in Alleviating the Pain of Toothache
An observational study of Tooth Pain, run by Albany Medical College at 1 site in United States.
Trial summary
Toothache is a common source of pain for Emergency Department patients. There are several common ways to control the pain of toothache. But we do not know if any one of them is more effective than another. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Pain
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients identified by ED providers as having dental pain will be screened for enrollment.
Who may be able to join
- > 18 years, pain in any tooth
Who cannot join
- duration of pain > 96 hours
- oral trauma within 96 hours of presentation
- facial or neck swelling
- pericoronitis
- visual impairment to less than finger counting within three feet
Trial locations and contacts
1 site in 1 country.
About this study
Toothache is a common source of pain for Emergency Department patients. There are several common ways to control the pain of toothache. But we do not know if any one of them is more effective than another. It is also possible that how we take care of your pain in the Emergency Department will influence the level of pain you experience one or two days from now. This study seeks to answer these questions.
- Conditions
- Tooth Pain
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Injectable pain medication | Patients who receive an injectable form of pain medication. | |
| Oral pain medication | Patients who receive oral pain medication only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Scale
Is there any change in patient report of pain using the Visual Analog Pain Scale before and after treatment.
Measured: Before and After treatment of tooth pain
Secondary outcomes (1)
Need for additional treatment
Does patient require addtional/repeated analgesia or rescue medication?
Measured: while in the Emergency Department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Triner, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268436
- Sponsor's protocol ID
- 2709
- Acronym
- Cohort Dental
- Status last verified
- Dec 2010
- First submitted
- 29 Dec 2010
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Comparison of Dental Nerve Block With Other Forms of Analgesia in Alleviating the Pain of Toothache
- ClinicalTrials.gov ID
- NCT01268436
- Acronym / sponsor ID
- Cohort Dental / 2709
- Conditions
- Tooth Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Dec 2010 (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.
Toothache is a common source of pain for Emergency Department patients. There are several common ways to control the pain of toothache. But we do not know if any one of them is more effective than another. It is also possible that how we take care of your pain in the Emergency Department will influence the level of pain you experience one or two days from now. This study seeks to answer these questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injectable pain medication | – | –Patients who receive an injectable form of pain medication. |
| Oral pain medication | – | –Patients who receive oral pain medication only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients identified by ED providers as having dental pain will be screened for enrollment.
Key inclusion criteria (1 listed)
- > 18 years, pain in any tooth
Key exclusion criteria (5 listed)
- duration of pain > 96 hours
- oral trauma within 96 hours of presentation
- facial or neck swelling
- pericoronitis
- visual impairment to less than finger counting within three feet
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
Visual Analog Pain Scale
Time frame: Before and After treatment of tooth pain
Is there any change in patient report of pain using the Visual Analog Pain Scale before and after treatment.
1 secondary outcome
Need for additional treatment
Time frame: while in the Emergency Department
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 24 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tooth Pain, run by Albany Medical College 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 1 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 24 Mar 2014. 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.
What does the primary outcome measure?
Visual Analog Pain Scale (time frame: Before and After treatment of tooth pain). It is what the study was designed to measure, not a finding.
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 24 Mar 2014.