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Completed

NCT Number: NCT05227300

Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis

The purpose of this study is to determine whether one type of anesthetic (numbing medicine) will work better at numbing the nerve in a tooth than using a different type of anesthetic. A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics.

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Key information

Conditions

Symptomatic Irreversible Pulpitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University School of Dentistry Graduate Endodontics Dept.

Indianapolis, Indiana, 46202, United States

About this study

40 subjects with a mandibular molar diagnosed with symptomatic irreversible pulpitis will be randomly allocated into 2 groups. One group will receive a total of 3 cartridges of a standard, unbuffered 2% lidocaine with 1:100,000 epinephrine via inferior alveolar nerve block (IANB) followed by supplemental buccal and lingual infiltrations, while the other will receive the equivalent yet buffered formulation. An electronic pulp tester (EPT) will be used to objectively determine baseline pulpal status of the affected tooth, followed by 2-minute interval testing following the administration of all local anesthesia. The onset of pulpal anesthesia is defined by the first of 2 consecutive EPT=80 readings, and the endodontic treatment may begin. Profound pulpal anesthesia is ultimately determined if the patients report a comfortable pulpotomy as reflected on the Wong-Baker FACES Visual Analog Scale.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

- In order to participate, subjects must:

  • Be between the ages of 18 and 80 years old
  • Have the ability and willingness to independently consent to treatment and study participation
  • Have an uncomplicated medical history (ASA I and II)
  • Not be pregnant
  • Have no allergies local anesthetics/sulfites (confirmed or self-reported)
  • Not be taking any medications that may affect the proper assessment of the anesthetic (no acetaminophen or short-acting NSAIDs such as ibuprofen within the previous 6 hours; no long-acting NSAIDs such as naproxen within the previous 16 hours)
  • Not require nitrous oxide during treatment, and the injection area should appear healthy with no other pre-existing conditions or infections that may compromise an accurate collection of data
  • Be experiencing signs of irreversible pulpitis (an exaggerated response to cold that lingers longer than 10 seconds) in a mandibular molar at the time of conducting the study

Exclusion criteria

- No subjects will have:

  • A negative response to cold in the proposed treatment tooth
  • A radiographic periradicular pathosis more advanced than a widened periodontal ligament or have an intraoral swelling

Treatment and study plan

Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution

Drug

Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic

2% lidocaine with 1:100,000 epinephrine

Drug

Septodont's standard formulation of 2% lidocaine with epinephrine

Primary outcomes

  1. VAS Scores as Measures of Profoundness of Pulpal Anesthesia

    Time frame: Up to 20 minutes post-drug administration

    The mean Visual Analog Scale (VAS) score, which ranges from a min of 1 to a max of 10. In other words, inadequate anesthesia is considered to be a VAS score that is between 4 and 10 because that is not considered to be "comfortable and profound".

Secondary outcomes

  1. Onset of Pulpal Anesthesia

    Time frame: Up to 20 minutes post-drug administration

    Duration of time in minutes required to achieve pulpal anesthesia, defined as an electrical pulp test score of 80 (which is the maximum stimulation). Any EPT score between 1-79 after 20 minutes post-anesthesia is considered a failure of pulpal anesthesia.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis: A Controlled, Randomized Double-blind Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 7, 2022
Registry last updated
May 14, 2024

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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