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Completed

NCT Number: NCT05338671

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

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.

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Key information

Conditions

Endodontic Disease Dental Pulp Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms Stomatognathic Diseases Symptomatic Irreversible Pulpitis Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Washington- School of Dentistry

Seattle, Washington, 98112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Local anesthetic

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2022
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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