OdontalgiaLAAEPNCT01982799
Local Anesthesia and Analgesics in Endodontic Pain
A study testing Oral ibuprofen, oral naproxen and oral acetaminophen/hydrocodone + ibuprofen in people with Odontalgia, run by University of Minnesota at 1 site in United States.
Trial summary
For patients with a toothache, is pain relief after root canal procedure improved using long acting local anesthetic and analgesics? The purpose of this clinical trial is the investigate the effect of long acting local anesthetic with 1 of 4 oral medication groups, on post-operative endodontic pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Odontalgia
- What is being tested?
- Oral ibuprofen, oral naproxen and oral acetaminophen/hydrocodone + ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2015
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 y.o. American Society of Anesthesiologists physical classification I or II Can understand and complete pain evaluation forms tooth pain (>3 out of 10) needing root canal Ability to read and provide informed consent Must be able to swallow tablets
Who cannot join
- Allergy/intolerance to analgesics (ibuprofen, naproxen, vicodin) Patients who are pregnant Patients currently on pain medications for an unrelated condition Patients unwilling to fill out pain scales Liver or kidney disease Unable to understand and complete consent form and pain evaluation forms
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota School of Dentistry
Minneapolis, Minnesota, 55455
About this study
Official title: Local Anesthesia and Analgesics in Post-Operative Endodontic Pain
For patients with a toothache, is pain relief after root canal procedure improved using long acting local anesthetic and analgesics? The purpose of this clinical trial is the investigate the effect of long acting local anesthetic with 1 of 4 oral medication groups, on post-operative endodontic pain.
Read the detailed description
Patients (n=220) presenting to the University of Minnesota Endodontic clinic, with moderate to severe pain from toothache requiring root canal treatment ,will be invited to participate in the study. The endodontic treatment is NOT part of the research. Patients will complete pain evaluation forms and take 2 doses of prescribed medication. Normally after a root canal procedure, patients will be suggested to take over-the-counter ibuprofen if needed, or prescribed an analgesic if they are having severe pain. We will be randomizing patients in double blind manner to receive regular or long acting local anesthesia and post-op medications (placebo or 1 of 3 analgesics), with the patient evaluating their pain before starting root canal (pre-treatment pain), after root canal, after analgesics and during the following day.
- Conditions
- Odontalgia
- Being tested
- Oral placebo, Oral ibuprofen, oral naproxen, oral acetaminophen/hydrocodone + ibuprofen
- Keywords
- Endodontic treatment, analgesics, anesthesia, post-operative pain
- Medical subject headings
- Toothache, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral placeboDrug
placebo
Oral ibuprofenDrug
Ibuprofen
oral naproxenDrug
naproxen
oral acetaminophen/hydrocodone + ibuprofenDrug
Also called Vicodin plus ibuprofen
vicodin/ibuprofen
| Study group | Role | What they receive |
|---|---|---|
| Endododontic Tx + Long acting local anesthetic | Experimental | long acting local anesthetic Receives: Drug: Oral placebo; Drug: Oral ibuprofen; Drug: oral naproxen; Drug: oral acetaminophen/hydrocodone + ibuprofen |
| Endodontic Tx plus local anesthetic | Experimental | local anesthetic Receives: Drug: Oral placebo; Drug: Oral ibuprofen; Drug: oral naproxen; Drug: oral acetaminophen/hydrocodone + ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of long acting anesthesia and analgesics on endodontic pain
Pain evaluation time points - pretreatment, after endodontic treatment, 2 hrs after analgesic dosing, following day
Measured: 36 hours
Secondary outcomes (1)
Effect of gender and age on post-operative endodontic pain treatment
Effect of gender and age will be evaluated based on data from pain evaluation forms
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Not enough funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OdontalgiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walter Bowles, DDS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982799
- Sponsor's protocol ID
- 22245
- Acronym
- LAAEP
- Status last verified
- Nov 2016
- First submitted
- 31 Oct 2013
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthesia and Analgesics in Post-Operative Endodontic Pain
- ClinicalTrials.gov ID
- NCT01982799
- Acronym / sponsor ID
- LAAEP / 22245
- Conditions
- Odontalgia
- Keywords
- Endodontic treatment, analgesics, anesthesia, post-operative pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Nov 2013 (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.
For patients with a toothache, is pain relief after root canal procedure improved using long acting local anesthetic and analgesics? The purpose of this clinical trial is the investigate the effect of long acting local anesthetic with 1 of 4 oral medication groups, on post-operative endodontic pain.
Detailed description
Patients (n=220) presenting to the University of Minnesota Endodontic clinic, with moderate to severe pain from toothache requiring root canal treatment ,will be invited to participate in the study. The endodontic treatment is NOT part of the research. Patients will complete pain evaluation forms and take 2 doses of prescribed medication. Normally after a root canal procedure, patients will be suggested to take over-the-counter ibuprofen if needed, or prescribed an analgesic if they are having severe pain. We will be randomizing patients in double blind manner to receive regular or long acting local anesthesia and post-op medications (placebo or 1 of 3 analgesics), with the patient evaluating their pain before starting root canal (pre-treatment pain), after root canal, after analgesics and during the following day.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endododontic Tx + Long acting local anesthetic | Experimental | Drug: Oral placebo, Drug: Oral ibuprofen, Drug: oral naproxen, Drug: oral acetaminophen/hydrocodone + ibuprofenlong acting local anesthetic |
| Endodontic Tx plus local anesthetic | Experimental | Drug: Oral placebo, Drug: Oral ibuprofen, Drug: oral naproxen, Drug: oral acetaminophen/hydrocodone + ibuprofenlocal anesthetic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-65 y.o. American Society of Anesthesiologists physical classification I or II Can understand and complete pain evaluation forms tooth pain (>3 out of 10) needing root canal Ability to read and provide informed consent Must be able to swallow tablets
Key exclusion criteria (2 listed)
- Allergy/intolerance to analgesics (ibuprofen, naproxen, vicodin) Patients who are pregnant Patients currently on pain medications for an unrelated condition Patients unwilling to fill out pain scales Liver or kidney disease Unable to understand and complete consent form and pain evaluation forms
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral placeboplacebo | Drug | Endododontic Tx + Long acting local anesthetic, Endodontic Tx plus local anesthetic |
| Oral ibuprofenIbuprofen | Drug | Endododontic Tx + Long acting local anesthetic, Endodontic Tx plus local anesthetic |
| oral naproxennaproxen | Drug | Endododontic Tx + Long acting local anesthetic, Endodontic Tx plus local anesthetic |
| oral acetaminophen/hydrocodone + ibuprofenAlso: Vicodin plus ibuprofenvicodin/ibuprofen | Drug | Endododontic Tx + Long acting local anesthetic, Endodontic Tx plus local anesthetic |
Primary outcome
Effect of long acting anesthesia and analgesics on endodontic pain
Time frame: 36 hours
Pain evaluation time points - pretreatment, after endodontic treatment, 2 hrs after analgesic dosing, following day
1 secondary outcome
Effect of gender and age on post-operative endodontic pain treatment
Time frame: 36 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
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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.
Walter Bowles, DDS principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral ibuprofen, oral naproxen and oral acetaminophen/hydrocodone + ibuprofen in people with Odontalgia, run by University of Minnesota 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 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: withdrawn, as of the sponsor's last update on 3 Nov 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
Effect of long acting anesthesia and analgesics on endodontic pain (time frame: 36 hours). 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 3 Nov 2016.