Endodontic DiseasePhase 4NCT05338671
Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment
A Phase 4 study testing Local anesthetic in people with Endodontic Disease and Post Operative Pain, run by University of Washington at 1 site in United States.
Trial summary
This study will assess the efficacy of two local anesthetics (2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine) in reducing post-operative pain in patients receiving endodontic treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease, Post Operative Pain, Symptomatic Irreversible Pulpitis
- What is being tested?
- Local anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2021to 1 Jun 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of symptomatic irreversible pulpitis on mandibular, posterior tooth
- ASA I or II
- >18 years old
Who cannot join
- Maxillary or mandibular anterior tooth
- Diagnosis of pulp necrosis or reversible pulpitis
- Tooth deemed non-restorable
- <18 years old
- ASA III, IV, or V
- Patients who are contraindicated to take ibuprofen
- Patients with allergies to any medications being assessed in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington- School of Dentistry
Seattle, Washington, 98112
About this study
This study will assess the efficacy of two local anesthetics (2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine) in reducing post-operative pain in patients receiving endodontic treatment.
Read the detailed description
The goal of this study is to assess the efficacy of 2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine in reducing post-operative pain in patients with symptomatic irreversible pulpitis on a mandibular tooth that receive endodontic treatment. Participants of this study will include patients that present to the University of Washington Endodontic clinic and fit the inclusion criteria of being >18 years old, healthy (ASA I or II) and having a diagnosis of symptomatic irreversible pulpitis on a mandibular tooth, that is willing to undergo endodontic treatment in two visits. Upon diagnosis, and informed consent, patients will be asked to participate in this study. If enrolled in the study, participants will receive standard endodontic treatment with temporary placement of Calcium Hydroxide medicament within the canals of the tooth and placement of a temporary filling. They will then be randomized to receive an inferior alveolar nerve block with 1 cartridge (1.8mL) of either 2% lidocaine 1:100,000 epinephrine or 0.5% bupivicaine 1:200,000 epinephrine. Patients will be given a form to track their pain levels for the next 72 hours, that they will return at a follow up visit. This form will use the Heft-Parker visual analog pain scale to track pain levels as well as ask participants to track their use of over the counter analgesics, in particular, Advil/ibuprofen. The pain tracking form will be returned to the clinic and root canal will be completed also at this follow up visit.
- Being tested
- Local anesthetic
- Keywords
- endodontics, root canal, lidocaine, bupivicaine, ibuprofen, symptomatic irreversible pulpitis, post operative pain, heft parker visual analog scale
- Medical subject headings
- Dental Pulp Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anestheticDrug
Patients will receive inferior alveolar nerve block injection following endodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| 2% Lidocaine 1:100,000 epinephrine | Active comparator | Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 2% Lidocaine 1:100,000 epinephrine following endodontic treatment. Receives: Drug: Local anesthetic |
| 0.5% bupivicaine 1:200,000 epinephrine | Active comparator | Participants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 0.5% bupivicaine 1:200,000 epinephrine following endodontic treatment. Receives: Drug: Local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain Level 6 Hours on a Visual Analog Scale
Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.
Measured: Patients will be asked to track pain levels at 6 post-operatively on a visual analog scale
Post-operative Pain Level 12 Hours on a Visual Analog Scale
Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.
Measured: Patients will be asked to track pain level at 12 hours post-operatively on a visual analog scale
Post-operative Pain Level 24 Hours on a Visual Analog Scale
Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.
Measured: Patients will be asked to track pain level at 24 hours post-operatively on a visual analog scale
Post-operative Pain Level 48 Hours on a Visual Analog Scale
Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.
Measured: Patients will be asked to track pain level at 48 hours post-operatively on a visual analog scale
Post-operative Pain Level 72 Hours on a Visual Analog Scale
Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.
Measured: Patients will be asked to track pain level at 72 hours post-operatively on a visual analog scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start29 Sep 2021
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two different arms each receiving an inferior alveolar nerve block with two different local anesthetics
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avina Paranjpe, University of Washington
- Investigators
- Avina Paranjpe, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338671
- Sponsor's protocol ID
- STUDY00013406
- Status last verified
- May 2025
- First submitted
- 19 Jun 2021
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Kahtani A. Effect of long acting local anesthetic on postoperative pain in teeth with irreversible pulpitis: Randomized clinical trial. Saudi Pharm J. 2014 Jan;22(1):39-42. doi: 10.1016/j.jsps.2013.01.004. Epub 2013 Jan 26.
PubMed 24493972Dunsky JL, Moore PA. Long-acting local anesthetics: a comparison of bupivacaine and etidocaine in endodontics. J Endod. 1984 Sep;10(9):457-60. doi: 10.1016/S0099-2399(84)80270-8. No abstract available.
PubMed 6387029Moradi S, Naghavi N. Comparison of bupivacaine and lidocaine use for postoperative pain control in endodontics. Iran Endod J. 2010 Winter;5(1):31-5. Epub 2010 Feb 20.
PubMed 24778680Parirokh M, Yosefi MH, Nakhaee N, Manochehrifar H, Abbott PV, Reza Forghani F. Effect of bupivacaine on postoperative pain for inferior alveolar nerve block anesthesia after single-visit root canal treatment in teeth with irreversible pulpitis. J Endod. 2012 Aug;38(8):1035-9. doi: 10.1016/j.joen.2012.04.012. Epub 2012 May 30.
PubMed 22794202
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment
- ClinicalTrials.gov ID
- NCT05338671
- Acronym / sponsor ID
- STUDY00013406
- Keywords
- endodontics, root canal, lidocaine, bupivicaine, ibuprofen, symptomatic irreversible pulpitis, post operative pain, heft parker visual analog scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Posted 29 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy of two local anesthetics (2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine) in reducing post-operative pain in patients receiving endodontic treatment.
Detailed description
The goal of this study is to assess the efficacy of 2% lidocaine 1:100,000 epinephrine and 0.5% bupivicaine 1:200,000 epinephrine in reducing post-operative pain in patients with symptomatic irreversible pulpitis on a mandibular tooth that receive endodontic treatment. Participants of this study will include patients that present to the University of Washington Endodontic clinic and fit the inclusion criteria of being >18 years old, healthy (ASA I or II) and having a diagnosis of symptomatic irreversible pulpitis on a mandibular tooth, that is willing to undergo endodontic treatment in two visits. Upon diagnosis, and informed consent, patients will be asked to participate in this study. If enrolled in the study, participants will receive standard endodontic treatment with temporary placement of Calcium Hydroxide medicament within the canals of the tooth and placement of a temporary filling. They will then be randomized to receive an inferior alveolar nerve block with 1 cartridge (1.8mL) of either 2% lidocaine 1:100,000 epinephrine or 0.5% bupivicaine 1:200,000 epinephrine. Patients will be given a form to track their pain levels for the next 72 hours, that they will return at a follow up visit. This form will use the Heft-Parker visual analog pain scale to track pain levels as well as ask participants to track their use of over the counter analgesics, in particular, Advil/ibuprofen. The pain tracking form will be returned to the clinic and root canal will be completed also at this follow up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two different arms each receiving an inferior alveolar nerve block with two different local anesthetics
| Arm | Type | Receives |
|---|---|---|
| 2% Lidocaine 1:100,000 epinephrine | Active comparator | Drug: Local anestheticParticipants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 2% Lidocaine 1:100,000 epinephrine following endodontic treatment. |
| 0.5% bupivicaine 1:200,000 epinephrine | Active comparator | Drug: Local anestheticParticipants in this arm will receive an inferior alveolar nerve block with 1 cartridge (1.8 mL) of 0.5% bupivicaine 1:200,000 epinephrine following endodontic treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of symptomatic irreversible pulpitis on mandibular, posterior tooth
- ASA I or II
- >18 years old
Key exclusion criteria (7 listed)
- Maxillary or mandibular anterior tooth
- Diagnosis of pulp necrosis or reversible pulpitis
- Tooth deemed non-restorable
- <18 years old
- ASA III, IV, or V
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 |
|---|---|---|
| Local anestheticPatients will receive inferior alveolar nerve block injection following endodontic treatment. | Drug | 0.5% bupivicaine 1:200,000 epinephrine, 2% Lidocaine 1:100,000 epinephrine |
Primary outcome
Post-operative Pain Level 6 Hours on a Visual Analog Scale
Time frame: Patients will be asked to track pain levels at 6 post-operatively on a visual analog scale
Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.
Post-operative Pain Level 12 Hours on a Visual Analog Scale
Time frame: Patients will be asked to track pain level at 12 hours post-operatively on a visual analog scale
Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.
Post-operative Pain Level 24 Hours on a Visual Analog Scale
Time frame: Patients will be asked to track pain level at 24 hours post-operatively on a visual analog scale
Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.
Post-operative Pain Level 48 Hours on a Visual Analog Scale
Time frame: Patients will be asked to track pain level at 48 hours post-operatively on a visual analog scale
Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.
Post-operative Pain Level 72 Hours on a Visual Analog Scale
Time frame: Patients will be asked to track pain level at 72 hours post-operatively on a visual analog scale
Participants will be asked to track the amount of pain they have following their endodontic treatment using the Heft-Parker visual analog scale with scores ranging from 0-170 with higher scores signifying more pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24493972Al-Kahtani A. Effect of long acting local anesthetic on postoperative pain in teeth with irreversible pulpitis: Randomized clinical trial. Saudi Pharm J. 2014 Jan;22(1):39-42. doi: 10.1016/j.jsps.2013.01.004. Epub 2013 Jan 26.
- Background: PubMed 6387029Dunsky JL, Moore PA. Long-acting local anesthetics: a comparison of bupivacaine and etidocaine in endodontics. J Endod. 1984 Sep;10(9):457-60. doi: 10.1016/S0099-2399(84)80270-8. No abstract available.
- Background: PubMed 24778680Moradi S, Naghavi N. Comparison of bupivacaine and lidocaine use for postoperative pain control in endodontics. Iran Endod J. 2010 Winter;5(1):31-5. Epub 2010 Feb 20.
- Background: PubMed 22794202Parirokh M, Yosefi MH, Nakhaee N, Manochehrifar H, Abbott PV, Reza Forghani F. Effect of bupivacaine on postoperative pain for inferior alveolar nerve block anesthesia after single-visit root canal treatment in teeth with irreversible pulpitis. J Endod. 2012 Aug;38(8):1035-9. doi: 10.1016/j.joen.2012.04.012. Epub 2012 May 30.
- Individual participant dataSharing planned: No
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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.
Avina Paranjpe principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Local anesthetic in people with Endodontic Disease and Post Operative Pain, run by University of Washington 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 3 inclusion and 7 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 29 May 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Pain Level 6 Hours on a Visual Analog Scale (time frame: Patients will be asked to track pain levels at 6 post-operatively on a visual analog scale). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05338671, which also lists 4 linked publications.
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 29 May 2025.