Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment

NCT ID: NCT05338671

Last Updated: 2025-05-29

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-29

Study Completion Date

2024-06-01

Brief Summary

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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

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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.

Conditions

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Endodontic Disease Post Operative Pain Symptomatic Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two different arms each receiving an inferior alveolar nerve block with two different local anesthetics
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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2% Lidocaine 1:100,000 epinephrine

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.

Group Type ACTIVE_COMPARATOR

Local anesthetic

Intervention Type DRUG

Patients will receive inferior alveolar nerve block injection following endodontic treatment.

0.5% bupivicaine 1:200,000 epinephrine

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.

Group Type ACTIVE_COMPARATOR

Local anesthetic

Intervention Type DRUG

Patients will receive inferior alveolar nerve block injection following endodontic treatment.

Interventions

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Local anesthetic

Patients will receive inferior alveolar nerve block injection following endodontic treatment.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of symptomatic irreversible pulpitis on mandibular, posterior tooth
* ASA I or II
* \>18 years old

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Avina Paranjpe

Professor: School of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Avina Paranjpe

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington- School of Dentistry

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24493972 (View on PubMed)

Dunsky 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.

Reference Type BACKGROUND
PMID: 6387029 (View on PubMed)

Moradi 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.

Reference Type BACKGROUND
PMID: 24778680 (View on PubMed)

Parirokh 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.

Reference Type BACKGROUND
PMID: 22794202 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00013406

Identifier Type: -

Identifier Source: org_study_id

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